Month: July 2018

DC Durable Medical Equipment Company Owner Pleads Guilty To Defrauding Medicaid

This week, it was announced that the owner of a company that provided durable medical equipment had pleaded guilty to a federal charge of health care fraud. The defendant carried out a scheme to fraudulently obtain more than $9.4 million in District of Columbia Medicaid payments. 72-year-old Waveney Blackman of Bowie, Maryland pleaded guilty. She is now scheduled to be sentenced on October 18, 2018.

The defendant was the sole owner and CEO of WaveCare Health Services LLC, which was also known as WaveCare Healthcare Services LLC. The company provided durable medical equipment, such as wound care and incontinence supplies to Medicaid beneficiaries and others. The company became a Medicaid provider in 2008. Plea documents show that Blackman devised and carried out a scheme to submit false and fraudulent claims to Medicaid for durable medical equipment .. read more

Healing lamp lights the way for improved treatment of chronic ulcers

Chronic skin ulcers such as those associated with diabetes are notoriously difficult to treat. As a result, we’ve seen experimental approaches such as spray-on skin, ultrasound band-aids, and silver-laced dressings. Now, scientists are getting very good results using a high-tech lamp.

Developed by a team from Britain’s University of Manchester and Salford Royal NHS Trust, the device has a total of 32 bulbs which emit a combination of infrared, red and ultraviolet light.

Led by Dr. Michael Hughes, the researchers tested it on eight patients suffering from systemic sclerosis, a condition in which the immune system attacks the fingers and toes. Each person received two 15-minute treatments per week, for a period of three weeks … read more

Till We Get the Healing Done

It is estimated that in the United States alone, diabetes affects 29 million people. Patients who suffer from this illness are susceptible to chronic leg and foot ulcers. These diabetic wounds are particularly likely to lead to amputations, due to a disruption in the healing process caused by the illness. In this context, finding aids to artificially accelerate the healing process for diabetic wounds is crucial.

One presently used technique for accelerating the healing process, is the direct injection of stem cells into the wound. This has been shown to significantly increase the rate of wound healing. However, the injection protocol reduces the lifespan of the cells though mechanical damage. Once the cells have been injected, there is no cell matrix present, further limiting their viability … read more

Trinity University students researching a new diabetic wound care treatment

At Trinity University’s Department of Engineering Science, students aren’t just taking the summer off. Many are doing important research about diabetes that they hope will eventually save limbs and lives.

“Everyone is very excited to hear about the work we are doing, and it’s nice to hear that it’s going to impact lives around me,” junior Abbie Jones said.

Abbie and her research partner Adil have been working on a way to help common diabetic wounds heal faster using something called a “hydro-gel wound dressing,” which helps heal from the inside out.

“With a hydro-gel, you can lay more inside and on top of the wound, instead of a Band-Aid, to help with the wound healing process,” said Jones, adding that research like this is needed because the number of diabetics is skyrocketing. “There are a large number of Type 2 diabetics in the U.S. currently, and many of them have the foot ulcers that are common occurrence with diabetes.”

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Diabetes doubles risk for hospital-acquired foot ulcers

Patients with diabetes have at least double the risk for developing hospital-acquired foot ulcers vs. those without diabetes, according to a study published in BMJ Open Diabetes Research & Care.

In a prospective, multilevel regression analysis, Frances Wensley, PhD, MBBS,formerly of the Royal Free Hospitals NHS Foundation Trust in London, and colleagues analyzed data from 18,946 patients with 28,642 admissions of at least 2 days to the Ipswich Hospital NHS Trust between October 2008 and September 2010, including 3,076 individuals with diabetes with 5,043 admissions. Patients included in the analysis were aged at least 50 years and developed a hospital-acquired foot ulcer at least 48 hours after hospital admission. For all admissions, the analyses included data on diabetes, heel ulcer, length of stay and other covariates. The researchers compared patients with vs. without diabetes … read more

CMS ends hyperbaric oxygen treatment experiment despite savings

The CMS will not continue an experiment that saved Medicare millions of dollars by reducing the use of non-emergency hyperbaric oxygen therapy.

The treatment uses pressurized oxygen to help expedite wound healing, particularly for diabetic wound care. Since the CMS launched the experiment in 2015, its spending per beneficiary per quarter dropped by $60, according to a report released Monday by the CMS. Federal data shows the experiment saved the government $17.6 million by 2017.

Only Illinois, Michigan and New Jersey participated in the prior authorization experiment for non-emergency hyperbaric oxygen therapy. Those states were chosen because of their high utilization and improper payment rates.

The demonstration ended in February 2018, and the savings it generated didn’t harm quality of care, according to the report … read more

Use of negative pressure wound therapy in a chronic leg wound with

coexisting rheumatoid arthritis: a case study

We present a case of a 69-year-old woman with rheumatoid arthritis. The patient’s condition was managed with steroid therapy for more than 12 years. She had a coexisting infected chronic ulceration in the left leg, which was treated with negative pressure wound therapy for 52 days. Use of this therapy within the wound reduced exudate and the bacterial count, which dramatically accelerated the process of wound healing.

The introduction of negative pressure wound therapy (NPWT) in the early 1990s resulted in a change in the concept of care and treatment of wounds of various aetiologies in the hospital and outpatient care settings. NPWT is increasingly being used in primary and home health care because of its non-invasiveness, high efficacy, shortening the time of wound healing, and improving wound healing, thereby greatly reducing the need for hospital treatment.^1–3 NPWT requires specialized equipment with manual control of negative pressure. Negative pressure is maintained in the wound bed with ready-made sterile sets (sponge, proper dressing, adapter, polyurethane foil). Negative pressure causes wound shrinkage and reduction of the bacterial count by evacuating the effusion into a disposable canister placed on the device.^4,5 Although the potential of NPWT … read more

Decision Memo for Hyperbaric Oxygen (HBO) Therapy

(Section C, Topical Oxygen) (CAG-00060R)

The Centers for Medicare & Medicaid Services (CMS) received a reconsideration request to remove the coverage exclusion of Continuous Diffusion of Oxygen Therapy (CDO) from NCD Manual 20.29, Section C. This section of the NCD (Topical Application of Oxygen) considers treatment known as CDO as the application of topical oxygen and nationally non-covers this treatment.

After examining the evidence, CMS has decided that no National Coverage Determination is appropriate at this time concerning the use of topical oxygen for the treatment of chronic wounds. We will amend NCD 20.29 by removing Section C, Topical Application of Oxygen and Medicare coverage of topical oxygen for the treatment of chronic wounds will be determined by the local contractors.

Summary:

Chronic wounds are prevalent in the Medicare population and cause a disproportionate burden on beneficiaries and their families and caretakers. CMS recognizes the need for new therapies that will heal wounds and the standardization of wound care in general. Overall, since the evidence on chronic wound healing from topical oxygen therapies has increased over the past few years, CMS believes a national non-coverage decision is no longer appropriate. CMS received 17 public comments and most of the commenters support this position. However, given the inability to identify the characteristics of chronic wounds that best respond to topical oxygen therapy and the type of patients’ best suited to use this therapy, we are not able to define a patient population that would benefit from topical oxygen therapy in a national coverage determination at the present time. Ongoing research in the US and Europe and pending publications may provide additional evidence that may support a national determination in the future. CMS realizes that double blinded RCTs cannot always be used in order to answer questions regarding the outcomes of exposure to various treatment regimens in the wound care space. However we acknowledge that various investigative groups have, and are currently, studying the treatment of chronic wounds by TOT through randomized controlled trials. CMS reviewed a number of articles from commenters, considered all additional information and has determined to finalize the proposed decision.

Conclusion

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OxyGenesys Dissolved Oxygen Dressing at Northwestern University

Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound healing will be observed over 14 days.

At least 12 study visits will occur over a 3 month timeframe. Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound healing will be observed over 14 days (follow up assessments include wound photography, pain scores, wound biopsies, exudate collection, gene expression and proteomic analysis, scar assessment and adverse event collections. Study visits will occur at:

Prescreening Visit; Day of wounding; Day 2; Day 7; Day 8-14 (until all wounds have healed); Day 28; Day 42; Abdominoplasty Surgery. An abdominoplasty will occur after day 42.

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What would our health care system look like if doctors spoke the same

language as engineers?

Medical school students today are trained to diagnose complicated diseases, but they are rarely trained to engineer the solutions themselves. To change that, soon Texas A&M University will start training doctors and nurses to also be engineers.

“Our technology [is] is a bandage that generates oxygen from the chemical decomposition of hydrogen peroxide,” Frey said. A chemical reaction between the layers of the bandage creates a concentrated oxygen gas which Frey said helps a wound heal. MedNoxa is seeking FDA clearance to sell the bandages by prescription and over the counter … read more

OxyBand 3×4 Inch Application Video

Application directions for applying the OxyBand 3×4 Wound Care Device on a wound.
OxyBand provides pure oxygen into the wound for up to 5 days promoting faster
healing with decidedly less pain than the current standard of care.

Introduction to OxyBand

Not all foams redistribute pressure equally

Recent research demonstrates the effectiveness of various foam dressings for pressure redistribution. Jeffrey Niezgoda, MD (APWCA Vice-President) recently published his findings in a poster presentation (SAWC 2018). His results demonstrated that all foams are not equivalent in the ability to provide pressure relief in patients at risk for developing pressure ulcers. OxyBand Rescue out performed all other foam dressings currently on the market, providing superior reduction in average pressures and peak pressures, while at the same time maximizing contact area. The NPUAP has recently published recommendations advocating the use of foam dressings to provide pressure redistribution in an attempt to reduce the risk of pressure ulcer formation in at risk patients. A copy of the Poster is provided.

From the The American Professional Wound Care Association® (APWCA)

Patients With Infected Diabetic Foot Ulcers Need Quick Referral

Patients with an infected diabetic foot ulcer have a far worse prognosis than previously thought, with 15% of patients dying within a year, less than half of the ulcers healing in the same time period, and one in seven individuals having all or part of their foot amputated, results from a new UK study reveal.

The analysis of almost 300 patients with infected diabetic foot ulcers also showed that, even if the ulcer healed, nearly 10% experienced a recurrence within 12 months and more than 25% of patients underwent some kind of procedure.

It’s therefore crucial that such patients are reviewed quickly and referred for specialist care if required, say Mwidimi Ndosi, PhD, of the University of West Bristol, United Kingdom, and colleagues in their paper published online November 20 in Diabetic Medicine … read more (registration required)

Smart Textiles Offer Development Opportunities In Medical

The medical field benefits from textile innovations, and the rapid development of sensor technology brings new products to the healthcare and wellness market.

The textile news has presented a number of stories centered in and around the medical industry in recent months. Whether the news relates to implantables and grafts, coatings and additives for wellness and bacteria protection, or innovative uniform fabrics, the textile industry is playing a role in medical progress. One particular area of note is sensor technology. Rapid development is taking place in the sensor market, and many companies are developing smart textile products for medical and health-related applications.

Making Socks Smart
Recently, San Francisco-based health technology company Siren introduced Neurofabric™, a Diabetic Sock and Foot Monitoring System that features microsensors embedded directly into the fabric. Six sensors — three across the ball of the foot, one in the arch and one on the heel — continuously monitor foot temperature looking for variation … read more

Acute and Impaired Wound Healing: Pathophysiology and Current Methods for

Drug Delivery, Part 1: Normal and Chronic Wounds: Biology, Causes, and Approaches to Care

This is the first installment of 2 articles that discuss the biology and pathophysiology of wound healing, review the role that growth factors play in this process, and describe current ways of growth factor delivery into the wound bed. Part 1 discusses the latest advances in clinicians’ understanding of the control points that regulate wound healing. Importantly, biological similarities and differences between acute and chronic wounds are considered, including the signaling pathways that initiate cellular and tissue responses after injury, which may be impeded during chronic wound healing.

Acute and chronic wounds affect millions of people in the United States and around the world. In recent decades, clinicians have gained a better understanding of the mechanisms of normal wound repair process and causes of delays in healing. This progress has led to significant improvement in the quality of life of affected patients. This article reviews the latest insights and opportunities for wound repair science and innovations in wound care … read more

Medscape Residents Salary & Debt Report 2018

How much are residents earning in 2018, and are they satisfied with their earnings? How much debt do they have? More than 1900 residents in 29-plus specialties told us how much they earn, as well as the hours they work, how much scut work they have, and what their relationships with attendings, nurses, and PAs are like. All participants were enrolled in US medical resident programs. Average resident salary appears to be trending upward. Over the past 3 years, the average salary has increased by about 7%. The average salary for residents overall is $59,300 … read more

Efficacy of Honeydew Honey and Blossom Honey

on Full-thickness Wound Healing in Mice

The wound healing properties of honey, including blossom honey, are well known; however, the effects of honeydew honey during the wound healing process have not yet been investigated and thus remain unclear.Objective. This study compares the effects of honeydew honey with those of blossom honey. Materials and Methods. A total of 140 mice were divided into 2 control groups, which received either a hydrocolloid dressing (HCD; n = 22) or gauze (n = 22), and 4 experimental groups: honeydew honey (n = 23), Acacia honey (n = 23), Manuka honey (n = 22), and Japanese Pharmacopoeia honey (n = 28). Two circular full-thickness wounds were made and measured for 14 days. Each wound in the experimental groups was treated with 0.1 mL of honey and covered with gauze. Dressings in the control and experimental groups were changed daily. Results. The wounds in all of the honey groups and the HCD group were moist by day 14, while those in the gauze group were dry. The ratio of wound area to initial wound area and the number of inflammatory cells decreased during the inflammatory phase in all honey groups. However, the honey groups exhibited reepithelialization rates of < 40%, numerous neutrophils, weak wound contraction, and impaired collagen deposition in wounds after day … read more

Spider silk could be used to create artificial skin to help heal wounds

Unless your name is Peter Parker, you may not be aware of quite how versatile spider silk is as a material. In fact, aside from spinning webs, spider silk can also be used for a plethora of applications — from improving the quality of microphones in hearing aids to forming incredibly strong-yet-lightweight shields to forming microcapsules for delivering anti-cancer vaccines.

Now researchers from Sweden and India have come up with yet another novel use for spider silk’s unusual mix of strength and elasticity: Creating artificial skin and wound dressings for helping heal wounds.

“We have developed two types of silk-based constructs: Nanofibrous matrices which serve as bioactive wound dressings, and microporous sponges cultured with human skin cells to serve as artificial skin,” Biman Mandal, an associate professor in the Department of Biosciences … full article in Digital Trends

Healogics Inc. agrees to $22.51 million settlement

Jacksonville-based hyperbaric oxygen therapy company billed Medicare for unnecessary and unreasonable treatments.

Hyperbaric oxygen therapy provider Healogics Inc. agreed to pay up to $22.51 million to settle allegations that it violated the federal False Claims Act by knowingly causing wound care centers to bill Medicare for unnecessary and unreasonable treatments.

The company, based in Jacksonville, manages more than 700 hospital-based wound care centers in the U.S., including at Baptist Medical Center … read more

Phase 3 CREDENCE Renal Outcomes Trial of INVOKANA® is Being Stopped

Early for Positive Efficacy Findings

– INVOKANA® has the potential to be the first new therapy in more than 15 years for slowing the progression of chronic kidney disease in patients with type 2 diabetes

– Worldwide, 160 million patients with type 2 diabetes are at risk for developing chronic kidney disease

– CREDENCE assessed INVOKANA® for renal protection by evaluating the risk reduction of the composite endpoint of time to dialysis or kidney transplantation, doubling of serum creatinine, and renal or cardiovascular death, when used in addition to standard of care

RARITAN, N.J., July 16, 2018 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Phase 3 CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) clinical trial, evaluating the efficacy and safety of INVOKANA^® (canagliflozin) versus placebo when used in addition to standard of care for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), is being stopped early based on the achievement of pre-specified efficacy criteria.

The decision is based on a recommendation from the study’s Independent Data Monitoring Committee (IDMC) that met to review the data during a planned interim analysis. This recommendation was based on demonstration of efficacy, as the trial had achieved pre-specified criteria for the primary composite endpoint of end-stage kidney disease (time to dialysis or kidney transplantation), doubling of serum creatinine, and renal or cardiovascular (CV) death, when used in addition to standard of care … read more

Prevention and Management of Diabetic Foot Ulcers

BEST PRACTICE RECOMMENDATIONS FOR THE Prevention and Management of Diabetic Foot Ulcers

Diabetes mellitus (DM) is a metabolic disorder characterized by hyperglycemia that leads to microvascular, macrovascular and neuropathic complications. In 2016, there were 11 million Canadians living with type 1, type 2 or pre-diabetes, and every three minutes another Canadian is diagnosed. Certain populations are at higher risk for developing type 2 DM, including those of Asian, African, Hispanic and Indigenous decent. The rates of DM are three to five times higher in Indigenous populations, an issue compounded by unique barriers to care including, but not limited to, a lack of cultural competency among health-care providers, jurisdictional confusion, limited access to care, geographical location and language barriers.1,2 Foot health should be a major consideration for people with diabetes and for those who care for them. Foot complications in this high-risk population can lead to a cascade of negative complications, potentially resulting in loss of limb and life. The lifetime risk for foot ulceration in people with diabetes is 15 to 25%. According to the International Diabetes Federation … read more (PDF)

Differences in Joint Mobility and Foot Pressures Between

Black and White Diabetic Patients

Limited joint mobility is common in diabetes and is related to high foot pressures and foot ulceration. We have examined the differences in joint mobility and foot pressures in four groups matched for age, sex, and duration of diabetes: 31 white diabetic, 33 white non‐diabetic, 24 black diabetic, and 22 non‐diabetic black subjects. Joint mobility was assessed using a goniometer at the fifth metacarpal, first metatarsal, and subtalar joints. In‐shoe and without shoes foot pressures were measured using an F‐Scan system. Neuropathy was evaluated using clinical symptoms (Neuropathy Symptom Score), signs (Neuropathy Disability Score), and Vibration Perception Threshold. There was no difference between white and black diabetic patients in Neuropathy Symptom Score, Neuropathy Disability Score, and Vibration Perception Threshold. Subtalar joint mobility was significantly reduced in white diabetic patients (22 ± 7°) compared to white controls (26 ± 4°, black diabetic patients (25 ± 5°), and black controls (29 ± 7°), and increased in black controls compared to white controls and black diabetic patients … read more

Study: Diabetic Foot Complications Among The Top 10 Causes Of Disability

David G. Armstrong DPM MD PhD

Diabetes-related lower extremity complications are a major cause of global disability, according to a recent study in Diabetic Medicine.

The study notes that of the 435 million people worldwide estimated to have diabetes, about 19 to 34 percent will experience a foot ulcer during their lifetimes.1 My coauthors and I note that diabetic foot complications are a leading cause of infection, hospitalization and amputation throughout the world although evidence-based care can prevent these outcomes … read more

Osiris Announces Enrollment of Patients in a Clinical Trial Evaluating

GrafixPL PRIME™ in the Treatment of Chronic Venous Leg Ulcers

COLUMBIA, Md., July 11, 2018 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (OTC Pink:OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, announced the initiation of its “Multicenter, Prospective, Randomized, Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL PRIME™ in the Treatment of Chronic Venous Leg Ulcers.”

This study is expected to enroll up to 200 patients in approximately 30 clinical sites. Patients will be randomized 1:1 to receive GrafixPL PRIME plus standard compression therapy (SOC) versus SOC alone in patients with chronic venous leg ulcers (VLUs). The study objective is to evaluate the safety and efficacy of weekly applications of GrafixPL PRIME plus SOC versus SOC alone for chronic VLUs with a size between 1 cm2 and 25 cm2. Patients in the SOC alone group whose ulcers do not close will be offered GrafixPL PRIME adjunct to SOC in a crossover extension treatment phase of up to 12 treatments … read more

Nutrition Management of Individuals with Diabetes and Pressure Injuries

by Dr. Nancy Munoz, DCN, MHA, RDN, FAND

The presence of diabetes can have a negative impact on wound healing rates. Increased glucose levels can stiffen the arteries and contribute to narrowing of the blood vessels. This can influence pressure injury development and is a risk factor for impaired wound healing.

Overview of Diabetes Mellitus
Diabetes is an illness in which the individual’s blood glucose level is above the established range. Glucose is present in the foods we eat. Most foods contain a blend of carbohydrates, proteins, and fats. The amount of each of these nutrients in the foods we consume determines how quickly the body transforms food into glucose. For instance, consuming carbohydrates affects blood glucose levels one to two hours after the meal. Ingesting protein has very little influence on blood glucose levels, and the glucose from the fat in foods is slowly absorbed and does not contribute to increased glucose levels … read more

CAN WE WOUND BIOFILMS?

These complex 3D structures of bacteria explain many of the challenges clinicians face with wound care, infection and healing. Scientists are fighting back.

Antonie van Leeuwenhoek (1632-1723) was the first person to delve into the field of microbiology and document initial observations of bacteria. After this preliminary discovery, microbiology was not actively studied again until the 1800s, when it began to gain a foothold in contemporary medicine. Fast-forward to today’s labs, where clinicians are becoming more knowledgeable in the bacteriology of wound healing, and researchers are identifying new ways to overcome long-standing challenges in wound healing, such as biofilms.

Biofilm is a term used to describe a colony of microorganisms, such as bacteria, fungi or yeast, encased by an extracellular polymeric substance (EPS). The EPS forms a shield, often causing the bacteria to be … read more

KCI Expands Offering of Next Generation

Negative Pressure Wound Therapy Dressing

SAN ANTONIO–(BUSINESS WIRE)– KCI, an Acelity Company, today announced the launch of the V.A.C. VERAFLO CLEANSE CHOICE™ Large Dressing designed for use with V.A.C. VERAFLO™ Therapy to cleanse larger wounds with thick, fibrous exudate and infectious material such as slough, and may be used on patients when surgical debridement must be delayed or is not possible or appropriate. With a unique, three-layer foam design with an array of holes, V.A.C. VERAFLO CLEANSE CHOICE™ Dressing allows for selective wound cleansing beyond traditional negative pressure wound therapy (NPWT) dressings, and provides flexibility in treating wounds of various depths.

“As an industry leader, we understand that wound care is incredibly complex and clinicians need more options – the combination of our core V.A.C.® Therapy technology with these new dressings shows remarkable potential for upending the traditional wound care approach, as illustrated by a growing body of clinical data,” said R. Andrew Eckert, President and CEO of Acelity. “Since launching V.A.C. VERAFLO CLEANSE CHOICE™ Dressing last year, we have seen tremendous response from clinicians with rapid adoption of the platform. Innovating for patients and customers is a driving force for our company, and we continue striving to revolutionize wound healing.”

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Therapy can accelerate wound healing

Using microcurrent therapy along with traditional wound care approaches significantly reduces wound size and lessens pain, according to a study in the Journal of Wound Care.

Harikrishna K.R. Nair, M.D., head of the wound care unit at Malaysia’s Hospital Kuala Lumpur, studied the effect of microcurrents on 100 chronic wound patients over four months in 2016. Their diagnoses included diabetic foot ulcers, venous leg ulcers and pressure ulcers … read more

Doctors who focus on the foot and brain team up on a smart insole

Professors David Armstrong and Charles Liu at first seemed to be an unlikely pair.

But the podiatric surgeon and neurosurgeon clicked on a personal level and promptly realized they had a lot to offer each other as Keck School of Medicine of USC collaborators.

Both were already studying how much information a person takes in through the nerves of the feet, how to preserve, repair or replace that information system, and how nerve damage can affect a patient’s mobility.

Armstrong is interested in metabolic health, mobility and neuropathy—the loss of nerve sensitivity that can occur in patients with diabetes, Liu noted.

“As a neurosurgeon, I’m interested in lower-extremity function and metabolic health, too,” he said. “In my work, I think about how to restore mobility to patients who can’t feel their legs. It’s a similar problem to diabetic foot ulcers.”

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A Total Offloading Foot Brace for Treatment of Diabetic Foot Ulcers

Results From a Halted Randomized Controlled Trial

Introduction. Foot offloading is the mainstay treatment for plantar diabetic foot ulcers (DFUs). Objective. This multicenter, single-blinded, randomized controlled trial evaluates the efficacy of a total offloading foot brace for healing plantar DFUs. Materials and Methods. Seventeen patients were randomized to standard therapy (ie, reducing stress and pressure via mechanical offloading) or offloading foot brace. Comparison of plantar pressures was performed using digital pressure sensing films. The ulcers were assessed by physical inspection and digital planimetry of photographs. Results. Reductions in peak plantar pressures ranged from 67.3% to 89.4% (P = .09). Healing at weeks 12 to 15 had minimal differences (brace vs. control: 71.7% vs. 80.3%, respectively). Although not significant, earlier periods of the brace versus the control demonstrated faster wound healing in weeks 2 to 5 (36.0% vs. 6.8%, respectively) and weeks 6 to 9 (50.7% vs. 17.0%, respectively). Conclusions. The total offloading foot brace minimizes plantar pressure, allowing for early healing of DFUs, and optimizations in brace design may enhance healing of plantar DFUs … read more

Controlling Bacterial Burden in Chronic Wounds

Bioburden in chronic wounds can be a principal contributor to inflammation, clinical wound infection, and further delayed wound healing. Clinically diagnosing infection in chronic wounds can be problematic because most individuals susceptible to developing chronic wounds are subject to physiological states that often blunt typical infectious responses in various ways.¹ These responses include pain, erythema, febrile state, leukocytosis, edema and increased wound exudate, wound odor, etc. For example, a patient with a neuropathic ulcer and diabetes mellitus may not report pain or fever or present with leukocytosis but will have increased edema and wound exudate. A patient with an ischemic ulcer of peripheral arterial disease may report pain, erythema, fever, and leukocytosis but not have perfusion sufficient to produce edema or increased wound exudate.¹ It is imperative to understand how to concurrently manage factors that can contribute to infection, as well as assess for symptoms and implement interventions to prevent infection … read more

Corstrata Announces Availability of New Tech Empowered

Diabetic Foot Ulcer & Amputation Prevention Solution

SAVANNAH, GA. (PRWEB) JULY 10, 2018

CORSTRATA, a provider of digital healthcare IT solutions and services for wound management, announced today the availability of the company’s new Diabetic Foot Ulcer & Amputation Prevention Solution. The Solution is designed to prevent costly and complicated wounds from developing and is the first comprehensive program that leverages state-of-the-art technology and a team of top-tier Board Certified Wound Clinicians for the early detection of ulcers that often lead to hard-to-heal wounds and amputations among the growing U.S. diabetic population.

Diabetic foot ulcers (DFUs) are a common, limb-threatening and expensive complication of Type 1 and Type 2 diabetes. Today, more than 30M people in the U.S. have diabetes and more than 1.7M suffer from new DFUs per year with a 40% reulceration rate. 80K of these diabetics ultimately require an amputation and the risk of death at 5 years for DFU patients is 2.5 times as high as the risk for a patient with diabetes without a foot ulcer.

“The Corstrata Diabetic Foot Ulcer and Amputation Solution offers an important advancement in both the detection and prevention of one of the most costly and complex types of wounds to heal,” said Katherine Piette, Chief Executive Officer and Founder, Corstrata. “The mobile and remote monitoring technology combined with our deep clinical expertise in diabetic foot ulcer prevention and wound management, enable us to help payers and value-based care organizations significantly reduce their risk and costs associated with ulcerations in diabetic members.”

The Corstrata program is a comprehensive end-to-end technology-enabled solution that uses the HIPAA compliant, Corstrata Intervention & Engagement mobile app and the industry’s only FDA approved smart thermometric mat. The Solution is designed to help value-based care organizations and payers with the following:

High-Risk Patient Identification
Program Enrollment
Daily Remote Patient Monitoring
Member Engagement & Education
Timely Evidenced-Based Intervention for Prevention of DFU
Empowering Members for Self-Management

“Research indicates that the use of early detection technology, coupled with evidence-based interventions, can prevent 75% of foot ulcers in this high-risk population,” said Joseph Ebberwein, Chief Financial Officer and Founder, Corstrata. Lower extremity amputation studies and clinical trials have shown that Diabetic Foot Ulcer and Amputation prevention solutions can greatly reduce costly hospital visits and procedures associated with ulcerations and amputations, including:

Reduction in Hospitalizations
Decreased Hospital Days
Reduction in Amputations
Decreased Emergency Room Visits
Decreased Foot Ulcer Recurrence

Corstrata was also recently named a semifinalist in the T1D Exchange 2018 Diabetes Innovation Challenge. A poster depicting the Corstrata DFU solution was showcased at the public event on May 21, 2018, at the Royal Sonesto Boston in Cambridge, MA.

Learn more about the Corstrata Diabetic Foot Ulcer and Amputation Prevention Solution at Corstrata.com/Diabetic-Foot-Ulcer-Prevention.

About Corstrata
Corstrata was founded in 2015 by two passionate healthcare experts with the goal of improving access to technology enabled, evidence-based care for patients with chronic wounds, which currently costs the U.S. $33B annually. Home health agencies, hospices, self-funded employers, clinically integrated networks of doctors and related practitioners (CINs), and third-party payers (Medicare Advantage, Medicaid MCOs) can benefit from Corstrata’s unique combination of professional expertise, digital technologies and telemedicine to treat wound patients and support practitioners anywhere, any time. The company delivers a Comprehensive Wound Care Management Program, Wound Patient Consultations, and specific services such as wound program assessment, formulary design, treatment guidelines assessment, wound documentation review, and practitioner education. Wound program development is available for Pressure Injury (Ulcer) Prevention and Management, Diabetic Foot Ulcer Prevention and Management, Ostomy Care and Management, and Palliative Wound Management. For more information about Corstrata, visit Corstrata.com.

From PRWeb

Smart Bandages Give Better Treatment to Chronic Wounds

Engineers from Tufts University have developed a new prototype bandage that actively monitors the condition of chronic wounds and delivers the appropriate drug treatments to improve the chances of healing.

Chronic skin wounds from burns, diabetes and other medical conditions can overwhelm the regenerative capabilities of the skin and can lead to persistent infections and amputations.

However, the researchers designed the bandages with healing elements and thermoresposive drug carries that deliver tailored treatments in response to embedded pH, and temperature sensors that track infection and inflammation … read more

A smart bandage placed on an arm. Temperature and pH sensors in the bandage (right) are read by a microprocessor (left), which may trigger release of drug from the bandage by sending a current through heating elements. Credit: Tufts University

Low-cost prosthetic foot mimics natural walking

Prosthetic limb technology has advanced by leaps and bounds, giving amputees a range of bionic options, including artificial knees controlled by microchips, sensor-laden feet driven by artificial intelligence, and robotic hands that a user can manipulate with her mind. But such high-tech designs can cost tens of thousands of dollars, making them unattainable for many amputees, particularly in developing countries.

Now MIT engineers have developed a simple, low-cost, passive prosthetic foot that they can tailor to an individual. Given a user’s body weight and size, the researchers can tune the shape and stiffness of the prosthetic foot, such that the user’s walk is similar to an able-bodied gait. They estimate that the foot, if manufactured on a wide scale, could cost an order of magnitude less than existing products … read more

How to apply silver nitrate

Topical application of silver nitrate is often used in wound care to help remove and debride hypergranulation tissue or calloused rolled edges in wounds or ulcerations. It’s also an effective agent to cauterize bleeding in wounds. Silver nitrate is a highly caustic material, so it must be used with caution to prevent damage to healthy tissues.

Application method
Silver nitrate applicators are firm wooden sticks with 75% silver nitrate and 25% potassium nitrate embedded on the tip. Moistening the tip sparks a chemical reaction that burns organic matter (skin), coagulates tissue, and destroys bacteria.

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Retired surgeon leads local diabetes study

SHERIDAN — After working as an orthopedic surgeon for 20 years, Dr. Scott Nickerson was forced into an early retirement by diabetes.

After graduating from the Johns Hopkins University School of Medicine, Nickerson moved to Sheridan in 1977 to work as an orthopedic surgeon at Sheridan Orthopaedics, which was a small three-doctor practice at the time.

One of the many complications of diabetes is neuropathy, nerve damage that can lead to pain, weakness and loss of sensation in the extremities.

Nickerson said after living with diabetes for about 10 years, he began to notice his hands were getting clumsy.

“I would drop tools a little bit or just not have quite the sensation you would depend on to do the work,” Nickerson said. “Plus it would hurt me a lot to be on my feet.”

Nickerson decided to retire so the effects of his neuropathy would not affect his work as a surgeon … read more

Electrically charged bandages help to heal burn wounds

combat antibiotic resistance

Researchers from the Ohio State University Wexner Medical Center have developed special electrically charged bandages that can prevent infections, combat antibiotic resistance and enable healing in burn wounds. This type of dressing turns electrically active when it comes in contact with bodily fluids. According to Dr. Chandan Sen, director of Ohio State’s Center for Regenerative Medicine and Cell Based Therapies, who led the study with colleagues at the Medical Center’s Comprehensive Wound Center and Center for Microbial Interface Technology, “Drug resistance in bacteria is a major threat, and antibiotic-resistant biofilm infections are estimated to account for at least 75 percent of bacterial infections in the United States. This is the first pre-clinical long-term porcine study to recognize the potential of ‘electroceuticals’ as an effective platform technology to combat wound biofilm infection.”

Medilight develops light system to heal wounds

European project makes bandage that bathes wound in blue light to speed recovery.

With the objective of using light to improve wound healing and within the framework of the European project MEDILIGHT, Swiss company CSEM and six partners have developed a new solution for treating chronic wounds. This portable device delivers blue light to improve and accelerate the healing process. The prototype was first presented this week at the project wrap-up event on July 2nd, at the URGO Laboratories in Dijon, France.

Chronic wounds are often difficult to treat, because they do not follow the typical injury healing process or time-frame. The resulting burden is significant, affecting over 40 million patients worldwide and costing healthcare systems an estimated €40 billion annually.

Blue light is known for its anti-microbial and anti-inflammatory effects in the initial stages of the healing process; it does not damage tissue, unlike the hazardous UV light. However, clear evidence of the beneficial effects of blue-light irradiation in the later stages of wound healing was still missing, thus hindering the development of effective solutions for complete therapy … read more

Heberprot-P to Deliver Effective Treatment Against Amino Acid

Metabolism Disorders; Nestle Health Sciences and Codex Collaboration to Enhance CodeEvolver Enzyme Platform

Metabolism is essentially a process that the human body uses to gain energy from food intake. In case of a metabolic disorder, improper food digestion takes place. Amino acids are referred to as building blocks. In case of metabolism disorders, breaking of amino acids becomes difficult that can lead to difficulty in getting them in cells. These complications can lead to generation of harmful substances in the body that can ultimately lead to life threatening or serious health problems. Such disorders are typically inherited, which makes their early diagnosis followed by effective treatment imperative. New-born babies are screened for such disorders via blood tests. According to analysis of Future Market Insights, the global market for amino acid metabolism disorders treatment is expected to grow at a high CAGR during the forecast period, 2017-2026 … read more

Superbug-Resistant Bandages

A staple of the news headlines in the UK over the past couple of years has been the periodic outbreak of so-called ‘Superbug’ infections in hospitals, when antibiotic-resistant strains of bacteria cause a high proportion of secondary infections in patients. Although the majority of such infections are relatively mild, they can develop into potentially fatal conditions including sepsis, toxic shock syndrome and necrotizing pneumonia. To keep things in context, the Superbug (or methicillin-resistant Staphylococcus aureus (MRSA)), for all its virulence, is simply the latest and most advanced version of a problem that spans human history – how to effectively combat bacterial infections that develop in wounds or injuries. Such infections were nearly always fatal before the development and wide-scale use of antibiotics; for example, in a military context, secondary infection and disease accounted for a far greater number of casualties than outright combat (at higher than a 2:1 ratio in the US Civil War) in the nineteenth century. In the ongoing medical arms race between diseases and treatment, then, MRSA is the next evolution on the side of the diseases, and a challenge that scientists and medics are working to meet … read more

Restoring the Wound Base: The Role of Tissue Management

Successful utilization of the TIME model for wound bed preparation requires a working knowledge of chronic wound tissue types. In addition, building on this foundational knowledge is the development of accurate wound assessment skills. These components combined will assist the clinician in implementing the appropriate interventions for each wound.

Viable Chronic Wound Tissue Types
The term “viable” describes vascular tissue with dynamic biological activity.

Epithelium: This should be dry to touch and can appear white or light pink; it is composed of restratified keratinocytes arising from the basement membrane of the dermis.

Granulation: This appears light pink to red and should be moist with a bumpy texture. Capillaries give granulation tissue its characteristic color, and collagen made from fibroblasts provides structural support. If granulation tissue is pale (poor perfusion), dark red or ruddy (vascular congestion or stasis), or “bubbly” or friable (bleeds with very gentle contact), it is technically considered non-viable because it will not support migrating epithelial cells … read more

Wound care and leg ulcer advances feature at conference

IT is estimated that annually the NHS treats over two million wounds at a cost of £5.3 billion and with tougher financial constraints being announced every year, there needs to be ongoing research to ensure the lack of finances doesn’t affect the quality of wound care available.

This was the topic of the opening lecture at the 3rd International Skin Integrity and Tissue Viability Conference hosted by the University of Huddersfield’s Institute of Skin Integrity and Infection Prevention (ISIaIP), in conjunction with the Journal of Wound Care.

The conference attracted 110 delegates from around the world and they listened to the former Head of Vascular Surgery at Bradford’s Royal Infirmary Professor Peter Vowden, as he gave the opening lecture entitled The Burden of Wound Care.

The recently retired wound care expert explained how wounds impose substantial health economic burden on the UK’s NHS.

He argued that it was comparable to that of managing obesity, which in 2012/2013 was valued at £5 billion. “Clinical and economic benefits would accrue from improved systems of care and an increased awareness of the impact that wounds impose on patients and the NHS”, said Professor Vowden … read more

Expert explains how wounds impose health economic burden on the UK’s NHS

Former Head of Vascular Surgery at Bradford’s Royal Infirmary Professor Peter Vowden gave the opening address at the 3rd International Skin Integrity and Tissue Viability Conference which explored advances in and the management of all aspects wound care.

It is estimated that annually the NHS treats over two million wounds at a cost of £5.3 billion and with tougher financial constraints being announced every year, there needs to be ongoing research to ensure the lack of finances doesn’t affect the quality of wound care available.

Paulsen takes another run at repealing the medical device tax

Rep. Erik Paulsen (R-Minn.), facing a tough re-election campaign, is taking yet another run at repealing the medical device tax.

Althought the 2.3% levy on prescribed medical devices was enacted as part of the Affordable Care Act in 2010, it didn’t go into effect until 2012 and was mothballed two years later; that moratorium, extended earlier this year, is slated to end in 2020.

Paulsen, who filed his first bill to repeal the tax back in 2010, introduced his latest repeal bid in January 2017. The bill, H.R. 184, or the “Protect Medical Innovation Act of 2017,” aims to “amend the Internal Revenue Code of 1986 to repeal the excise tax on medical devices.” The bill has 269 co-sponsors, including 43 Democrats.

Citing “sources familiar with the plan,” The Hill reported yesterday that the U.S. House of Representatives could vote on the Paulsen bill as early as this month … read more

Moldable Hyaluronan Hydrogel Enabled by Dynamic

Metal–Bisphosphonate Coordination Chemistry for Wound Healing

Biomaterial‐based regenerative approaches would allow for cost‐effective off‐the‐shelf solution for the treatment of wounds. Hyaluronan (HA)‐based hydrogel is one attractive biomaterial candidate because it is involved in natural healing processes, including inflammation, granulation, and reepithelialization. Herein, dynamic metal–ligand coordination bonds are used to fabricate moldable supramolecular HA hydrogels with self‐healing properties. To achieve reversible crosslinking of HA chains, the biopolymer is modified with pendant bisphosphonate (BP) ligands using carbodiimide coupling and chemoselective “click” reactions. Hydrogel is formed immediately after simple addition of silver (Ag⁺) ions to the solution of HA containing BP groups (HA‐BP). Compared with previous HA‐based wound healing hydrogels, the HA‐BP·Ag⁺ hydrogel is highly suitable for clinical use as it can fill irregularly shaped wound defects without the need for premolding. The HA‐BP·Ag⁺ hydrogel shows antimicrobial properties to both Gram‐positive and Gram‐negative bacterial strains, enabling prevention of infections in wound care. In vivo evaluation using a rat full‐thickness skin wound model shows significantly lower wound remaining rate and a thicker layer of regenerated epidermis as compared with the group left without treatment. The presented moldable and self‐healing supramolecular HA hydrogel with “ready‐to‐use” properties possesses a great potential for regenerative wound treatment … read more

Gel-E wins FDA OTC nod for gel-e Flex flowable hemostat

Early stage wound care company Gel-e said today it won FDA 510(k) clearance for its gel-e Flex as an over-the-counter flowable hemostat.

The College Park, Md.-based company said the clearance expands the labeling for the local management of lacerations and minor bleeding, and said the products were specifically designed to be usable by both trained professionals and patients.

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2018 Innovations in Neuro Therapies, Wound Management

Injectable Bandages, Biosensors, Skin Electrocardiograms, and Medical Cables – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Innovations in Neuro Therapies, Wound Management, Injectable Bandages, Biosensors, Skin Electrocardiograms, and Medical Cables” report has been added to ResearchAndMarkets.com’s offering.

The latest edition of Medical Device TOE profiles a wide diversity of innovations impacting the healthcare industry.

This issue identifies and describes early-stage innovations such as neuromodulation therapy to manage post-traumatic stress disorder (PTSD), implantable sensors for continuous medical monitoring, and bodyworn monitoring devices for mobile cardiac monitoring.

Mature technologies that have been, or are nearing, commercialization, such as drug-coated balloons for peripheral artery disease, and a novel delivery vehicle for timed release of vaccines are also discussed.

Key Topics Covered:

Neuromodulation Therapy for Traumatic Brain Injury
Pneumatic Compression Therapies for Lymphedema
Urinary Bladder Matrix for Wound Management & Soft Tissue Repair
Wearable Headphone to Completely Clear-out Earwax Buildup
Connected Device for Analysis of Wheezing Trend
Injectable Biosensors to Stream Medical Data
Ultra-thin Wearable Electrocardiogram Device
A Novel Biomaterial to Design Cancer Vaccines
Novel Drug-coated Balloon for Peripheral Artery Disease Treatment
Ultrathin Insulation for Medical Cables
Database of Key Industry Participants

For more information about this report visit https://www.researchandmarkets.com/research/nb5dbk/2018_innovations?w=4

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Related Topics: Biotechnology, Infusions and Injectables , Wound Care

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