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
Qualifiers
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
Treatments tested in this trial
- IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap
- IP2: BioLab Tri-Membrane Wrap
Treatment groups
165 Participants
are divided into 3 treatment groupsSponsors and collaborators
Capsicure, LLC
Lead sponsor
BioLab Holdings
Collaborator
Source ClinicalTrials.gov