Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorStability Biologics
About this trial
This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot and venous leg ulcers.
Eligibility criteria
Qualifiers
1. Subjects must be at least 21 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 cm2 measured post debridement .
Disqualifiers
The potential subject is known to have a life expectancy of < 6 months.
The potential subject's target ulcer is not secondary to diabetes.
The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
The target ulcer exposes tendon or bone.
Trial design
Treatments tested in this trial
- Standard of Care-DFU
- AmnioCore - DFU
- Amnio Quad-Core - DFU
- Standard of Care-VLU
- Amnio Tri-Core - VLU
- AmnioCore Pro
- Amniocore Pro +
Treatment groups
324 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Stability Biologics
Lead sponsor
SerenaGroup, Inc.
Collaborator
Source ClinicalTrials.gov