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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Bennett Sarver
• Email: info@serenagroups.com
• Phone: 1-833-865-6300

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using human placental membrane wraps with regular wound care to help heal stubborn diabetic foot and venous leg ulcers

  This trial tests whether adding one of four human placental membrane wraps to standard wound care helps people with nonhealing diabetic foot or venous leg ulcers heal faster and more completely than standard care alone.

  Recruiting Phase 4 BioLab Holdings · Philidelphia, Pennsylvania · NCT07089602

• Wound matrix treatments for nonhealing diabetic foot ulcers

  This trial will test whether adding special wound matrix products to standard care helps close hard-to-heal diabetic foot ulcers in adults with type 1 or 2 diabetes within 12 weeks.

  Recruiting Phase 4 Sequence LifeScience, Inc. · Monroeville, Pennsylvania · NCT07086443

• Evaluating new treatments for nonhealing diabetic foot and venous leg ulcers.

  This study is testing whether new treatments for stubborn diabetic foot and leg ulcers can help people heal better when combined with standard care compared to just standard care alone.

  Recruiting Phase 4 Tiger Biosciences, LLC. · Monroeville, Pennsylvania · NCT06826339

• How long healed diabetic foot ulcers stay closed after CAMPX treatment

  This follow-up tests whether diabetic foot ulcers that fully closed by 12 weeks in the CAMPX trial stay closed over a year using home photographic and thermal scans with the BlueDrop OneStep Foot Scanner.

  Recruiting Applied Biologics, LLC · Clinton Township, Michigan · NCT07360418

• Single-layer placental graft plus standard care for stubborn diabetic foot ulcers

  This trial will try a single-layer placental-based graft together with usual wound care for adults whose diabetic foot ulcers did not heal after standard treatment in an earlier trial.

  Recruiting Phase 4 Applied Biologics, LLC · Hollywood, Florida · NCT07159282

• Evaluating how long venous leg ulcers stay closed after treatment

  This study is testing how long venous leg ulcers stay closed after treatment with a special fish skin graft compared to standard care alone.

  Recruiting Kerecis Ltd. · Monroeville, Pennsylvania · NCT06697925

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.