CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapsicure, LLC
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Male or female 18 years of age and older
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
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)
Disqualifiers
Inability to adhere to the study protocol or study visit schedule
Pregnancy
Child-bearing potential without appropriate contraception
Lactation
Trial design
Design model
Parallel
Treatments tested in this trial
IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap
Other interventionBioLab 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
Other interventionBioLab 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.
Treatment groups
165 Participants
are divided into 3 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: IP1: BioLab Membrane Wrap LiteExperimental treatment 1 intervention
Group C: IP2: BioLab Tri-Membrane WrapExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
12 WeeksSecondary outcomes
1
Wound percent area reduction
To demonstrate real world utilization and utility of two novel amniotic tissue grafts to support a variety of meaningful clinical outcomes in an at-risk patient population this study will collect wound percent area reduction at 4, 8, 12 weeks, change from baseline in quality of life, based on changes in index wound quality of life Wound-Q, and subject pain scores.
Time frame
Weeks 4, 8, and 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Capsicure, LLC
Lead sponsor
BioLab Holdings
Collaborator
Source ClinicalTrials.gov