NCT06557122

Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers

A Randomized Controlled Clinical Trial Evaluating the Efficacy of a Unique Advanced Bioengineered Skin Substitute With Standard of Care Versus an Active Comparator With Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Encoll Corp · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute. The commercially available product is Helicoll® Advanced Skin Substitute. In this trial two groups of subjects with Wagner 1 diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. Half of the patients will have their SOC treatment with Epifix® or Grafix® and the other half will receive a 510K FDA cleared Helicoll® Advanced Skin Substitute as the primary treatment. The primary endpoint is the percentage wound area reduction of the target ulcer. Secondary endpoints include the proportion of subjects that obtain complete closure over the 5-week treatment period, the time to achieve complete wound closure of the target ulcer by the end of 5 weeks, and mean number of IP applications.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	SOC and Advanced Bioengineered Skin Substitute	SOC primary dressing with Helicoll®
OTHER	SOC and Active Comparator	SOC primary dressing with Epifix® or Grafix®

Timeline

• Start date: 2024-07-25
• Primary completion: 2024-10-25
• Completion: 2024-10-25
• First posted: 2024-08-16
• Last updated: 2025-05-22
• Results posted: 2025-05-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study