Human placental membrane products plus standard care for nonhealing diabetic foot and venous leg ulcers

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.

This trial will try human placental membrane products together with standard wound care to help adults whose diabetic foot ulcers or venous leg ulcers have not healed.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BioLab Holdings (Industry-sponsored)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Philidelphia, Pennsylvania)
• Trial ID: NCT07364630 on ClinicalTrials.gov

What this trial studies

This is a prospective, controlled, multicenter modified multi-platform rescue trial that gives human placental membrane products to patients who failed to heal on standard of care in the BIOCAMP trial. Patients who were in the BIOCAMP SOC arm and did not achieve complete closure by 12 weeks may enter this rescue arm and receive one of several placental membrane products. Participants must meet local Medicare Administrative Contractor (MAC) medical necessity criteria for cellular/acellular matrix-like products and agree to weekly study visits and prescribed offloading during treatment. The study uses standardized wound care plus application of one of the investigational membrane products and follows patients for wound closure outcomes.

Who should consider this trial

Good fit: Adults (≥18) with type 1 or 2 diabetes who were in the BIOCAMP standard-of-care arm, have the same target ulcer not healed by 12 weeks, meet MAC LCD medical necessity for CAMPs, and can attend weekly visits and use prescribed offloading.

Not a fit: Patients with non-diabetic ulcers, active infection or surrounding cellulitis, a life expectancy under six months, or who do not meet MAC medical necessity criteria are unlikely to benefit from this rescue intervention.

Why it matters

Potential benefit: If successful, the intervention could increase healing rates and shorten time to closure for nonhealing diabetic foot and venous leg ulcers.

How similar studies have performed: Prior trials of placental/amniotic membrane products for chronic foot and leg ulcers have shown promising healing rates in some controlled studies, but results vary and long-term evidence remains limited.

Eligibility criteria

Inclusion Criteria:

* The potential subject must be at least 18 years of age or older.
* The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
* If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the BIOCAMP study.
* The potential subject must consent to using the prescribed offloading method for the duration of the study.
* The potential subject must agree to attend the weekly study visits required by the protocol.
* The potential subject must be willing and able to participate in the informed consent process.
* The potential subject must have participated in the BIOCAMP trial in the SOC only arm and NOT achieved complete closure by the 12-week endpoint.

Exclusion Criteria:

* 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 or there is cellulitis in the surrounding skin.
* The target ulcer exposes tendon or bone.
* There is evidence of osteomyelitis complicating the target ulcer.
* There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
* The potential subject is taking hydroxyurea.
* The potential subject has applied topical steroids to the ulcer surface within one month of TV-1.
* The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of TV-1.
* The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
* The potential subject has end stage renal disease requiring dialysis.
* The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
* The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
* The potential subject did not participate in the BIOCAMP trial.
* The potential subject participated in the BIOCAMP trial and was not randomized to the SOC only arm.
* The potential subject participated in the BIOCAMP trial and achieved complete closure.
* The target ulcer was treated with CAMPs, also defined as skin substitute, or hyperbaric oxygen therapy (HBOT) in the month prior to TV-1.

Where this trial is running

Philidelphia, Pennsylvania

• Center for Foot and Ankle Disorders — Philidelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Bennett Sarver

Conditions Diabetic Foot Ulcer; Foot Ulcer Chronic; DFU; Ulcer Foot; Venous Leg Ulcer; Venous Ulcer; Leg Ulcers; Ulcer