Study of Placental Membrane Products for Diabetic Foot Ulcers
This study is looking at new ways to help non-healing diabetic foot ulcers and venous leg ulcers close. It compares different human placental membrane products (Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Lite™, and Membrane Wrap-Hydro™) combined with standard care, against standard care alone. Standard care involves cleaning, removing dead tissue (debridement), managing moisture, and relieving pressure (offloading) from the ulcer. You could be eligible if you are at least 18 years old, have type 1 or 2 diabetes, and have a diabetic foot ulcer between 1.0 and 20 cm². The main goal is to see what percentage of people achieve complete ulcer closure within 12 weeks. The study status is currently unclear.
- Study design
- This is a multi-center, randomized controlled study involving 650 participants. Participants will be randomly assigned to receive one of four placental membrane products plus standard care, or standard care alone.
- What's involved
- If you join, you will receive weekly treatment for up to 12 weeks, or until your ulcer closes. This includes weekly applications of your assigned treatment and regular evaluations by the investigator.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured over 12 weeks, with ulcer closure confirmed 2 weeks later.
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NCT07089602
Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Recruiting
PHASE4Ages 18+InterventionalTreatmentBioLab Holdings
~650 participants
Updated 2025-07-28 on ClinicalTrials.gov
What's tested:Standard of Care DFUTri-Membrane Wrap™ DFUMembrane Wrap™ DFUMembrane Wrap-Lite™ DFUMembrane Wrap-Hydro™ DFUStandard of Care 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
Determine the between-arm difference percentage of subjects achieving complete closure of target ulcer over 12 weeks.
Measured over 1-12 Weeks
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
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.
At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20 cm2 measured post debridement with the eKare inSight® imaging device.
The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.
The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.
The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
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 be at least 21 years of age or older.
At enrollment, the potential subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.
The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care prior to the initial screening visit.
The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
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.
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 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 surface area of the potential subject's target ulcer has reduced in size by more than 40% in the 4 weeks prior to Treatment Visit 1 ("historical" run-in period\*). OR The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit AND The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV-1 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 has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
The potential subject is known to have a life expectancy of \< 6 months.
The potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
The potential subject's target ulcer exposes tendon or bone.
There is evidence of osteomyelitis complicating the potential subject's target ulcer.
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 has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
The surface area of the potential subject's target ulcer has reduced in size by more than 40% in the 4 weeks prior to Treatment Visit 1 ("historical" run-in period\*). OR The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit AND The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV-1 visit.
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 has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
The potential subject has a wound with active or latent infection.
The subject has a disorder that would create unacceptable risk of post-operative complication.
What this trial measures
- Determine the between-arm difference percentage of subjects achieving complete closure of target ulcer over 12 weeks.1-12 Weeks
To determine the between-arm difference of multiple Human Placental Membrane (HPM) products plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers over 12 weeks using a modified dual platform (Matriarch) trial design. The initial plan is to evaluate several HPM per wound type; however, the modified platform design permits the inclusion of additional placental and umbilical cord derived products and can continue in perpetuity.