Actively Recruiting
A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing Human Placental Membrane Products and Standard Care for Nonhealing Diabetic Foot and Venous Leg Ulcers
Led by BioLab Holdings · Updated on 2026-02-09
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
BioLab Holdings
Lead Sponsor
S
Serena Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of human placental membrane products combined with standard care for treating nonhealing diabetic foot ulcers and venous leg ulcers. This multicenter, prospective, controlled trial follows a rescue design where patients who do not heal with standard care in a related trial may receive one of the study products. Patients must meet specific medical criteria for cellular or matrix-like products as outlined by Medicare guidelines. Participants are randomly assigned to receive one of several human amniotic membrane allograft products—Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Lite™, or Membrane Wrap-Hydro™—along with standard care. These products are applied weekly until the ulcer heals or up to a maximum of 12 weeks. The trial includes a rescue phase for those who fail to heal in the standard care arm of a previous related study. During the study, participants attend weekly visits for treatment application and monitoring. Researchers will assess wound closure percentage within 1 to 12 weeks as the primary outcome. Secondary measures include time to wound closure, area reduction, adverse events, quality of life improvements, and pain levels for those with significant pain. The total participation period may last up to 12 weeks, with regular evaluations to track healing and safety.
CONDITIONS
Brief Title
A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The participant must be at least 18 years old.
- Must have a diagnosis of type 1 or type 2 Diabetes mellitus.
- If multiple ulcers are present, the target ulcer must be the same one treated in the BIOCAMP study.
- Must agree to use the prescribed offloading method throughout the study.
- Must agree to attend weekly study visits as required.
- Must be willing and able to complete the informed consent process.
- Must have participated in the BIOCAMP trial in the standard of care only arm and not achieved complete closure by 12 weeks.
You will not qualify if you...
- Life expectancy less than 6 months.
- Target ulcer not caused by diabetes.
- Infected ulcer or cellulitis in surrounding skin.
- Ulcer exposing tendon or bone.
- Evidence of osteomyelitis complicating the ulcer.
- Infection requiring systemic antibiotic therapy.
- Receiving immunosuppressants or cytotoxic chemotherapy.
- Taking hydroxyurea.
- Applied topical steroids to the ulcer surface within one month before the first treatment.
- Previous partial amputation causing foot deformity that impedes proper offloading.
- Glycated hemoglobin (HbA1c) 12% or higher within 3 months before the first treatment.
- Acute or inactive Charcot foot impeding offloading.
- Pregnant or planning pregnancy within 6 months.
- End stage renal disease requiring dialysis.
- Medical or psychological condition interfering with study assessments.
- Malnutrition indicator score below 17.
- Did not participate in the BIOCAMP trial.
- Participated in BIOCAMP but was not in the standard of care only arm.
- Achieved complete closure in BIOCAMP trial.
- Treated the target ulcer with skin substitutes or hyperbaric oxygen therapy in the month before first treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 weeks or until ulcer closure
Participants will receive weekly applications of one of the human placental membrane products along with Standard of Care for their diabetic foot or venous leg ulcers until ulcer closure or a maximum of 12 weeks, whichever occurs first.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Center for Foot and Ankle Disorders
Philidelphia, Pennsylvania, United States, 19146
Actively Recruiting
Research Team
B
Bennett Sarver
T
Thomas Serena, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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