CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations

NARecruitingINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

July 20, 2026

Study Completion Date

July 20, 2026

Conditions
Diabetic Foot Ulcer (DFU)Venous Leg UlcerWound; Foot
Interventions
OTHER

IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap

BioLab Membrane Wrap LiteTM is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. Membrane Wrap LiteTM is a single-layer human tissue allograft, containing solely the amnion layer of Amniotic Membrane \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271.

OTHER

IP2: BioLab Tri-Membrane Wrap

BioLab Tri-Membrane WrapTM is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. Tri-Membrane WrapTM is a triple-layered human tissue allograft, containing amnion-chorion-amnion layers \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271.

Trial Locations (7)

11791

RECRUITING

Jevlos Health, Inc, Syosset

33134

RECRUITING

Solutions Medical Research, Coral Gables

33176

RECRUITING

Nova Medical Services - Research Division LLC, Miami

46202

RECRUITING

Indiana University Health Methodist Hospital, Indianapolis

63128

RECRUITING

St. Louis Foot and Ankle, LLC, St Louis

77054

RECRUITING

Hope Vascular and Podiatry, Houston

93030

RECRUITING

FOMAT Medical Research, Oxnard

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BioLab Holdings

INDUSTRY

lead

Capsicure, LLC

NETWORK