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

A Multicenter, Prospective, Randomized Controlled Modified Multi- Platform 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

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.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 650 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BioLab Holdings (Industry-sponsored)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Philidelphia, Pennsylvania)
• Trial ID: NCT07089602 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized controlled Phase 4 study that will enroll about 650 participants across up to 30 sites. Subjects are randomly assigned to receive one of four different human placental membrane products plus standard of care or standard of care alone, with weekly applications for up to 12 weeks or until the ulcer fully closes. Target ulcers are measured weekly using a digital imaging device and closure is confirmed two weeks after initial 100% closure. The design includes optional weekly dressing changes and regular investigator assessments to document healing progress.

Who should consider this trial

Good fit: Adults (≥18) with type 1 or 2 diabetes who have a nonhealing foot ulcer (Wagner grade 1–2) between 1.0 and 20 cm2 that has been present despite at least 4 weeks of standard care and who have adequate limb perfusion are ideal candidates.

Not a fit: Patients with exposed tendon or bone, poor blood flow to the affected limb, ulcers outside the specified size or duration limits, or those unable to attend weekly in-person visits are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, adding the placental membrane products could help more ulcers fully close and shorten the time to complete healing compared with standard care alone.

How similar studies have performed: Prior clinical work with placental membrane products has reported improved healing in some chronic wounds, but product types and study quality vary so evidence is promising but not uniformly conclusive.

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.
* 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:

  1. ABI between 0.7 and ≤ 1.3;
  2. TBI ≥ 0.6;
  3. TCOM ≥ 40 mmHg;
  4. PVR: biphasic.
* If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
* 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.

Exclusion Criteria: DFU

* 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.

  a. eKare inSight® imaging device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable)
* 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.

Inclusion Criteria:VLU

* 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:

  1. ABI between 0.7 and ≤ 1.3;
  2. TBI ≥ 0.6;
  3. TCOM ≥ 40 mmHg;
  4. PVR: biphasic.
* If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
* 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 Criteria:

* 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.

  a. \*eKare inSight® imaging device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable)
* 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.

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; DFU; Diabetic Foot Ulcer; Foot Ulcer, Diabetic; Ulcer Foot; Venous Leg Ulcer; Leg Ulcer; Leg Ulcers Venous