Clinical Trial Spotlight: Evaluating RGN-137 for Diabetic Foot Ulcers
Study Title: A Study to Evaluate the Safety and Efficacy of RGN-137 in Subjects With Diabetic Foot Ulcers (DFUs)
ClinicalTrials.gov Identifier: NCT05099367
Study Overview: This Phase 2, randomized, double-blind, placebo-controlled trial aims to assess the safety and efficacy of RGN-137, a topical gel formulation of thymosin beta 4, in promoting the healing of diabetic foot ulcers.
Key Details:
- Intervention: Participants will receive either RGN-137 topical gel or a placebo, applied to the ulcer site.
- Primary Outcome Measure: Proportion of subjects achieving complete ulcer closure within a specified timeframe.
- Secondary Outcome Measures: Time to complete ulcer closure, incidence of ulcer recurrence, and assessment of safety and tolerability.
Eligibility Criteria:
- Adults aged 18 years and older with Type 2 Diabetes Mellitus.
- Presence of a diabetic foot ulcer of a specified size and duration.
- Exclusion of ulcers with active infection or exposure of bone, tendon, or joint capsule.
Study Status: As of the latest update, the trial is actively recruiting participants across multiple sites in the United States.
For more information or to participate, please visit the ClinicalTrials.gov page.
Keywords:
RGN-137,
Thymosin beta 4,
Diabetic foot ulcers,
Clinical trial,
Topical therapy