CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
NCT ID: NCT07046767
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
165 participants
INTERVENTIONAL
2025-10-01
2026-07-20
Brief Summary
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Detailed Description
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Hybrid prospective platform 2 arm, comparative, randomized multicenter study with a CSM matched retrospective control group Interventional comparative study
* IP 1: BioLab Membrane Wrap Lite
* IP2: BioLab Tri-Membrane Wrap
Standard of care: Debridement, maintenance of proper moisture balance, reduction in bacterial burden, offloading and multilayer compression.
Patients with nonhealing venous leg ulcerations or diabetic foot ulcers of at least 4-weeks duration that have failed to show 50% PAR with SOC therapies Patients receiving SOC therapies for hard-to-heal VLUs and/or DFUs
To gather prospective real-world evidence (RWE) in both diabetic foot ulcers and venous leg ulcers increasing the understanding of treatment performance in everyday clinical settings, capturing insights from a more diverse patient population than traditional clinical trials. This information is vital for evaluating the effectiveness of innovative wound care strategies in practical, real-life scenarios
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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).
TREATMENT
NONE
Study Groups
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Standard of Care
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.)
No interventions assigned to this group
IP1: BioLab Membrane Wrap Lite
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 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.
IP2: BioLab Tri-Membrane Wrap
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.)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. 2\. 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
3. Subjects' wound size is minimum of 2 cm2 and maximum of 25cm2
4. If the subject has more than one eligible wound the largest wound will be selected (the index wound)
5. Subject is able and willing to follow the protocol requirements
6. Subject has signed informed consent
Exclusion Criteria
2. Pregnancy
3. Child-bearing potential without appropriate contraception
4. Lactation
5. Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.
6. 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)
7. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
8. Known contraindications to the use of amniotic tissue grafts
9. The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics
18 Years
ALL
No
Sponsors
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BioLab Holdings
INDUSTRY
Capsicure, LLC
NETWORK
Responsible Party
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Principal Investigators
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Windy Cole, DPM
Role: STUDY_DIRECTOR
Capsicure, LLC
Locations
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FOMAT Medical Research
Oxnard, California, United States
Solutions Medical Research
Coral Gables, Florida, United States
Nova Medical Services - Research Division LLC
Miami, Florida, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States
St. Louis Foot and Ankle, LLC
St Louis, Missouri, United States
Jevlos Health, Inc
Syosset, New York, United States
Hope Vascular and Podiatry
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CAMP RWE
Identifier Type: -
Identifier Source: org_study_id
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