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

NCT07046767 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2025-10-22

No results posted yet for this study

Summary

CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs

Conditions

  • Diabetic Foot Ulcer (DFU)
  • Venous Leg Ulcer
  • Wound; 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.

Sponsors & Collaborators

  • BioLab Holdings

    collaborator INDUSTRY

  • Capsicure, LLC

    lead NETWORK

Principal Investigators

  • Windy Cole, DPM · Capsicure, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-07-20
Completion
2026-07-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07046767 on ClinicalTrials.gov