Single-layer placental graft plus standard care for stubborn diabetic foot 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 multicenter, prospective, controlled Phase 4 rescue trial that gives a single-layer placental-based allograft in addition to standard of care to patients who failed to achieve closure in the standard-of-care arm of the prior CAMPX trial. Participants must meet local Medicare LCD medical necessity criteria for cellular/acellular matrix-like products and agree to weekly clinic visits and prescribed offloading. The protocol requires consent, target ulcer confirmation (diabetes-related), and excludes infected ulcers and patients with life expectancy under six months. The trial is managed by Applied Biologics with sites including Royal Research in Hollywood, Florida.

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 CAMPX 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 CAMPX 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 has applied topical steroids to the ulcer surface within one month of initial screening.
* 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 the initial screening visit.
* 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 CAMPX trial.
* The potential subject participated in the CAMPX trial and was not randomized to the SOC only arm.
* The potential subject participated in the CAMPX trial and achieved complete closure.

Where it's running

• Royal Research
  Hollywood, Florida, 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.

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• Evaluating a new placental-based treatment for diabetic foot ulcers

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

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• Using dehydrated human amnion membrane to treat nonhealing diabetic foot ulcers

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• Human placental membrane products plus standard care for nonhealing diabetic foot 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.

  Recruiting BioLab Holdings · Philidelphia, Pennsylvania · NCT07364630

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.