Use of Hypothermically Stored Amniotic Membrane on Diabetic Foot Ulcers: A Multicentre Retrospective Case Series
Summary: Researchers from US-based wound care sites published a multicentre retrospective case series in the Journal of Wound Care (March 2024 supplement) reporting clinical outcomes for diabetic foot ulcers (DFUs) managed with hypothermically stored amniotic membrane (HSAM), a cellular, acellular and matrix-like product (CAMP) classified as a human cellular and tissue-based product (HCT/P) under FDA oversight. HSAM differs from dehydrated and cryopreserved amniotic membrane allografts in that hypothermic storage conditions preserve viable differentiated and stem cell populations, growth factors, cytokines, and extracellular matrix proteins more completely — a distinction the authors argue may enhance clinical effectiveness. The study enrolled 50 patients across multiple US wound care sites; 68% were male with a mean age of 66.7 years. The majority of DFUs (88%) were present for fewer than 6 months at first presentation, and mean wound area at first presentation was 3.5 cm². From first presentation to baseline (the visit at which HSAM was first applied), mean percentage wound area reduction was −68.3%, reflecting the contribution of standard of care (SoC) pre-treatment. HSAM was then applied on top of continued SoC, and patients were followed over 12 weeks. The results suggest positive outcomes in terms of continued wound closure, with reduction in time to complete wound closure (CWC) noted as a key patient benefit — since shortened healing time translates to reduced financial burden and improved quality of life. The case series adds real-world evidence to prior randomized controlled trial data for HSAM in DFUs, including a 14-site RCT (Serena et al., 2020) that demonstrated a 60% closure rate at 12 weeks and a 75% greater probability of weekly wound closure versus standard of care alone.
Key Highlights:
- 50 patients across multiple US wound care sites; 68% male, mean age 66.7 years; 88% of DFUs present <6 months at first presentation
- Mean wound area 3.5 cm²; mean percentage area reduction of −68.3% from first presentation to HSAM baseline (reflecting SoC pre-treatment effect)
- HSAM mechanism: hypothermic storage preserves viable cells, stem cells, growth factors, cytokines, and ECM proteins — a key advantage over dehydrated and cryopreserved amnion products
- Prior RCT (Serena et al., 2020, n=76): HSAM produced 60% closure at 12 weeks vs. 38% SoC (p=0.004) and 75% greater probability of wound closure on a weekly basis over 16 weeks
- Shortened time to CWC cited as having downstream financial and quality-of-life benefits — average DFU cost estimated at $38,000–$54,000 if leading to amputation
- Authors: Anna Sanchez (San Antonio New Step, TX), Alan Hartstein and Hisham Ashry (Palm Beach Foot & Ankle, FL), Maryam Raza; data coordination supported by Organogenesis Inc.
Keywords: amniotic membrane wound care, hypothermically stored amniotic membrane, diabetic foot ulcer CAMPs, placental allograft wound, HSAM DFU, cellular tissue products wound healing
Anna Sanchez Alan Hartstein Hisham Ashry Maryam Raza