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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Standard of Care-DFU
Other interventionBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
AmnioCore - DFU
Other interventionParticipants will receive weekly applications of AmnioCore and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amnio Quad-Core - DFU
Other interventionParticipants will receive weekly applications of Amnio Quad-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Standard of Care-VLU
Other interventionBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amnio Tri-Core - VLU
Other interventionParticipants will receive weekly applications of Amnio Tri-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
AmnioCore Pro
Other interventionParticipants will receive weekly applications of AmnioCore Pro and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amniocore Pro +
Other interventionParticipants will receive weekly applications of Amniocore Pro + and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Treatment groups
324 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Standard of Care-DFUActive comparator 1 intervention
Group B: AmnioCore - DFUExperimental treatment 1 intervention
Group C: Amnio Quad-Core - DFUExperimental treatment 1 intervention
Group D: Amniocore Pro + - DFUExperimental treatment 1 intervention
Group E: Standard of Care-VLUActive comparator 1 intervention
Group F: Amnio Tri-Core - VLUExperimental treatment 1 intervention
Group G: AmnioCore Pro - VLUExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Determine the between-arm difference
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design.
Time frame
1-12 WeeksSecondary outcomes
1
Time to closure
To determine the between-arm difference in the time to closure over 12 weeks for CAMP plus SOC versus SOC alone.
Time frame
1-12 Weeks2
Percent Area Reduction
To determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus SOC alone.
Time frame
1-12 weeks3
Change in pain in target ulcer
To determine the between-arm difference in pain for patients that present with a VAS score of greater than 4.
Time frame
1-12 Weeks4
Adverse Events
To evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus SOC alone.
Time frame
1-14 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stability Biologics
Lead sponsor
SerenaGroup, Inc.
Collaborator
Source ClinicalTrials.gov