Recruiting

Human Placental Membrane Products with Standard of CareTrial 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

Sponsor:

BioLab Holdings

Code:

NCT07089602

Conditions

Diabetic Foot

DFU

Diabetic Foot Ulcer

Foot Ulcer, Diabetic

Ulcer Foot

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care DFU

Tri-Membrane Wrap™ DFU

Membrane Wrap™ DFU

Membrane Wrap-Lite™ DFU

Membrane Wrap-Hydro™ DFU

Study Details

Brief summary:

The purpose of this study is to evaluate 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.

Conditions

Diabetic Foot

DFU

Diabetic Foot Ulcer

Foot Ulcer, Diabetic

Ulcer Foot

Study ID

NCT07089602

Start date

Jul 15, 2025

Status verified date

Jul, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

650 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: DFU Standard of Care

Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Off-loading using the off-loading boot or total contact cast (TCC).

experimental: DFU Tri-Membrane Wrap™ + SOC

Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.

experimental: DFU Membrane Wrap™ + SOC

Membrane Wrap™ is an allograft derived from human amniotic membrane.

experimental: DFU Membrane Wrap-Lite™ + SOC

Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.

experimental: DFU Membrane Wrap-Hydro™ + SOC

Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.

active comparator: VLU Standard of Care

Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Compression using multilayer compression wraps.

experimental: VLU Tri-Membrane Wrap™ + SOC

Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane.

experimental: VLU Membrane Wrap™ + SOC

Membrane Wrap™ is an allograft derived from human amniotic membrane.

experimental: VLU Membrane Wrap-Lite™ + SOC

Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.

experimental: VLU Membrane Wrap-Hydro™ + SOC

Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.

Interventions

Standard of Care DFU

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Tri-Membrane Wrap™ DFU

Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Membrane Wrap™ DFU

Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Membrane Wrap-Lite™ DFU

Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Membrane Wrap-Hydro™ DFU

Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Standard of Care VLU

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Tri-Membrane Wrap™ VLU

Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Membrane Wrap™ VLU

Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Membrane Wrap-Lite™ VLU

Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Membrane Wrap-Hydro™ VLU

Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Primary outcome measure

Determine the between-arm difference percentage of subjects achieving complete closure of target ulcer over 12 weeks. [ Time Frame: 1-12 Weeks ]

Central Contacts and Locations

Central contacts

Bennett Sarver

888-960-1343 bsarver@serenagroups.com

Thomas Serena

814-688-4000 tserena@serenagroups.com

Locations

Center for Foot and Ankle Disorders

Recruiting

Philidelphia, Pennsylvania, United States, 19146

Contacts

Ryan Breisinger

412-965-5737 rbreisinger@serenagroups.com

More Information

Sponsor

BioLab Holdings

Last update posted

Jul 28, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BioLab Holdings on 2025-07-28.