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Study for Non-Healing Diabetic Foot and Venous Leg Ulcers

This study is looking at different human placental membrane products (Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Lite™, Membrane Wrap-Hydro™) to see how well they help heal non-healing diabetic foot ulcers and venous leg ulcers (open sores on the leg or foot). You would receive weekly applications of one of these products along with standard care for up to 12 weeks, or until your ulcer closes. The study aims to see how much the wounds close during this time. You may be able to join if you are at least 18 years old, have type 1 or 2 diabetes, and meet other specific criteria for your ulcer. The study is currently recruiting about 50 participants, but its overall status is unclear.

Study design
This is a multicenter, prospective, controlled study involving about 50 participants. It's designed as a "rescue" trial, meaning participants who didn't heal in a previous study (BIOCAMP) may join this one.
What's involved
You would receive weekly applications of a study product and standard care for up to 12 weeks, or until your ulcer heals. You must also agree to use a prescribed offloading method.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, percentage of wound closure, is measured between 1 and 12 weeks.

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NCT07364630

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.

Recruiting
PHASE4Ages 18+InterventionalTreatment
BioLab Holdings
~50 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:Tri-Membrane Wrap™ DFUMembrane Wrap™ DFUMembrane Wrap-Lite™ DFUMembrane Wrap-Hydro™ DFUTri-Membrane Wrap™ VLUMembrane Wrap™ VLU

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Wound Closure
Measured over 1-12 Weeks

Conditions

Diabetic Foot Ulcer
Foot Ulcer Chronic
DFU
Ulcer Foot
Venous Leg Ulcer (VLU)
Venous Leg Ulcer
Venous Ulcer
Leg Ulcers
Ulcer

Explore related trials

Diabetic foot ulcerStasis ulcer

Where it's being run

1 sites across 1 states
Pennsylvania1

Who to contact

Bennett Sarver
[email protected]
1-833-865-6300
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percentage of Wound Closure1-12 Weeks

    The percentage of target ulcers achieving complete wound closure in 12 weeks.