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

NCT07046767 | Recruiting

• 1 other identifier: CAMP RWE
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

DCF; VLU; Diabetic Foot Ulcer; Venus Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Wound Closure

  To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting wound healing compared to standard of care alone in venous leg ulcers and diabetic foot ulcers across the continuum of care. Thus, the incidence of index ulcers obtaining complete wound closure by 12 weeks will be collected.

  12 Weeks

Secondary Outcomes (1)

• Wound percent area reduction

  Weeks 4, 8, and 12

Study Arms (3)

Standard of Care

NO INTERVENTION

This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 165 in wound type.)

IP1: BioLab Membrane Wrap Lite

EXPERIMENTAL

This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 165 in wound type.)

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

IP2: BioLab Tri-Membrane Wrap

EXPERIMENTAL

This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 165 in wound type.)

Other: IP2: BioLab Tri-Membrane Wrap

Interventions

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

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.

IP1: BioLab Membrane Wrap Lite

IP2: BioLab Tri-Membrane Wrap OTHER

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.

IP2: BioLab Tri-Membrane Wrap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capsicure, LLC: lead
• BioLab Holdings: collaborator

Study Sites (7)

FOMAT Medical Research

Oxnard, California, 93030, United States

RECRUITING

Solutions Medical Research

Coral Gables, Florida, 33134, United States

RECRUITING

Nova Medical Services - Research Division LLC

Miami, Florida, 33176, United States

RECRUITING

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

St. Louis Foot and Ankle, LLC

St Louis, Missouri, 63128, United States

RECRUITING

Jevlos Health, Inc

Syosset, New York, 11791, United States

RECRUITING

Hope Vascular and Podiatry

Houston, Texas, 77054, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Foot Injuries

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins; Leg Injuries; Wounds and Injuries

Study Officials

• Windy Cole, DPM

  Capsicure, LLC

  STUDY DIRECTOR

Central Study Contacts

Marissa Docter, RN, BSN, MD

CONTACT

512-571-2966; mdocter@capsicure.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 165 in wound type).

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)