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

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 28, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Venous Leg Ulcers
Interventions
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

Trial Locations (1)

24016

RECRUITING

Professional Education and Research Institute, Roanoke

All Listed Sponsors
lead

Skye Biologics Holdings, LLC

INDUSTRY