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

NCT07089602 | Recruiting Phase 4

• 1 other identifier: BIOCAMP
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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; Venous Leg Ulcer; Leg Ulcer; Leg Ulcers Venous; Ulcer

Outcome Measures

Primary Outcomes (1)

• Determine the between-arm difference percentage of subjects achieving complete closure of target ulcer over 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.

  1-12 Weeks

Secondary Outcomes (7)

• Time to Closure

  1-12 weeks

• Percent Area Reduction (PAR)

  1-12 weeks

• Determine improvement in quality of life

  1-12 Weeks

• Pain in patients who present with VAS greater than 4

  1-12 weeks

• Proportion of patients that reach complete closure over 65

  1-12 weeks

Study Arms (10)

DFU Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care DFU

DFU Tri-Membrane Wrap™ + SOC

EXPERIMENTAL

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

Other: Tri-Membrane Wrap™ DFU

DFU Membrane Wrap™ + SOC

EXPERIMENTAL

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

Other: Membrane Wrap™ DFU

DFU Membrane Wrap-Lite™ + SOC

EXPERIMENTAL

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

Other: Membrane Wrap-Lite™ DFU

DFU Membrane Wrap-Hydro™ + SOC

EXPERIMENTAL

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

Other: Membrane Wrap-Hydro™ DFU

VLU Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care VLU

VLU Tri-Membrane Wrap™ + SOC

EXPERIMENTAL

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

Other: Tri-Membrane Wrap™ VLU

VLU Membrane Wrap™ + SOC

EXPERIMENTAL

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

Other: Membrane Wrap™ VLU

VLU Membrane Wrap-Lite™ + SOC

EXPERIMENTAL

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

Other: Membrane Wrap-Lite™ VLU

VLU Membrane Wrap-Hydro™ + SOC

EXPERIMENTAL

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

Other: Membrane Wrap-Hydro™ VLU

Interventions

Standard of Care DFU OTHER

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.

DFU Standard of Care

Tri-Membrane Wrap™ DFU OTHER

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.

DFU Tri-Membrane Wrap™ + SOC

Membrane Wrap™ DFU OTHER

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

DFU Membrane Wrap™ + SOC

Membrane Wrap-Lite™ DFU OTHER

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.

DFU Membrane Wrap-Lite™ + SOC

Membrane Wrap-Hydro™ DFU OTHER

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.

DFU Membrane Wrap-Hydro™ + SOC

Standard of Care VLU OTHER

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.

VLU Standard of Care

Tri-Membrane Wrap™ VLU OTHER

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.

VLU Tri-Membrane Wrap™ + SOC

Membrane Wrap™ VLU OTHER

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

VLU Membrane Wrap™ + SOC

Membrane Wrap-Lite™ VLU OTHER

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.

VLU Membrane Wrap-Lite™ + SOC

Membrane Wrap-Hydro™ VLU OTHER

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.

VLU Membrane Wrap-Hydro™ + SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ABI between 0.7 and ≤ 1.3;
• TBI ≥ 0.6;
• TCOM ≥ 40 mmHg;
• PVR: biphasic.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• BioLab Holdings: lead
• SerenaGroup, Inc.: collaborator

Study Sites (1)

Center for Foot and Ankle Disorders

Philidelphia, Pennsylvania, 19146, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer; Varicose Ulcer; Leg Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bennett Sarver

CONTACT

888-960-1343; bsarver@serenagroups.com

Thomas Serena

CONTACT

814-688-4000; tserena@serenagroups.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a multi-center, prospective, randomized controlled clinical study consisting of 650 subjects from up to 30 centers. The subjects are randomized to receive 1 of 4 treatments, either with Tri-Membrane Wrap™ (HPM-1); Membrane Wrap™ (HPM-2); Membrane Wrap-Lite™ (HPM-3); Membrane Wrap-Hydro™ (HPM-4); and SOC. The target ulcers are evaluated weekly by the investigator.

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 28, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)