NCT06764953

Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone

A Randomized Controlled Clinical Trial Evaluating The Efficacy of an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Skye Biologics Holdings, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with SOC versus FIBRACOL™ with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse events or reactions (side effects) * Change in pain levels * Occurrence of infection

Detailed description

The purpose of this clinical evaluation is to collect patient outcome data on a commercially available E-GRAFT™ that is a dehydrated thick amniotic allograft processed and approved for use as a Human Cellular and Tissue- Based Product (HCT/P) under FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act. In this trial, two groups of Venous Leg Ulcers (VLUs) will receive standard of care (SOC) treatment for their condition. Half of the patients will receive a 510K FDA cleared Collagen alginate dressing FIBRACOL™ and the other half will have E-GRAFT™ dehydrated tissue allograft as the primary dressing. The primary endpoint is the percentage of patients that go on to complete closure of the target ulcer between the two groups: SOC with FIBRACOL™ or SOC with E-GRAFT™. Secondary endpoints include the proportion of subjects achieving complete wound closure of the target ulcer by the end of 12 weeks.

Conditions

• Venous Leg Ulcers

Interventions

Type	Name	Description
OTHER	E-GRAFT ™	E-GRAFT™ that is a dehydrated thick amniotic allograft processed and approved for use as a Human Cellular and Tissue-Based Product (HCT/P) under FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act.
DEVICE	FIBRACOL™	510K FDA cleared Collagen alginate dressing

Timeline

• Start date: 2024-12-28
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study