RecruitingNot ApplicableNCT07046767

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

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

Sponsor

Capsicure, LLC

Enrollment

165 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Male or female 18 years of age and older
\. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of \>4 weeks duration and visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks
Subjects' wound size is minimum of 2 cm2 and maximum of 25cm2
If the subject has more than one eligible wound the largest wound will be selected (the index wound)
Subject is able and willing to follow the protocol requirements
Subject has signed informed consent

Exclusion Criteria9

Inability to adhere to the study protocol or study visit schedule
Pregnancy
Child-bearing potential without appropriate contraception
Lactation
Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.
Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)
The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
Known contraindications to the use of amniotic tissue grafts
The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics

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Interventions

OTHERIP1: 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.

OTHERIP2: 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.