Amniotic Membrane Product for Foot and Leg Ulcers
(CAMPR-II Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
CAMPR-II Trial: A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a saline-hydrated allogeneic dual-layer amniotic membrane product or a synthetic, resorbable polymeric wound matrix to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs
Who Is on the Research Team?
Windy Cole, DPM
Principal Investigator
Capsicure, LLC
Are You a Good Fit for This Trial?
This trial is for people with hard-to-heal diabetic foot ulcers (DFUs) or venous leg ulcers (VLUs). Participants should have chronic wounds that haven't responded well to standard treatments. Specific inclusion and exclusion criteria are not detailed here.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product
- Synthetic, Resorbable Polymeric Wound Matrix
Trial Overview
The study compares two advanced wound dressings—a saline-hydrated amniotic membrane wrap and a synthetic, dissolvable wound matrix—against past patient data. The goal is to see which helps heal stubborn foot and leg ulcers better.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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 147 in wound type.)
The 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 147 in wound type.)
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 147 in wound type.)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Capsicure, LLC
Lead Sponsor
BioLab Holdings
Industry Sponsor
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