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.

NCT07364630 | Recruiting Phase 4

• 1 other identifier: RescueX
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study is 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.

Conditions

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

Keywords

Leg Ulcer; Ulcer; Venous Ulcer; Venous Leg ulcer; VLU; DFU; Diabetic Foot Ulcer; Foot Ulcer; Diabetic foot

Outcome Measures

Primary Outcomes (1)

• Percentage of Wound Closure

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

  1-12 Weeks

Secondary Outcomes (6)

• Time to Closure

  1-12 weeks

• Percentage Area Reduction

  1-12 weeks

• Adverse Events

  1-12 Weeks

• Determine improvement in Quality of Life

  1-12 weeks

• Determine improvement in Quality of Life

  1-12 weeks

Study Arms (8)

Tri-Membrane Wrap™ DFU

OTHER

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

Other: Tri-Membrane Wrap™ DFU

Membrane Wrap™ DFU

OTHER

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

Other: Membrane Wrap™ DFU

Membrane Wrap-Lite™ DFU

OTHER

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

Other: Membrane Wrap-Lite™ DFU

Membrane Wrap-Hydro™ DFU

OTHER

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

Other: Membrane Wrap-Hydro™ DFU

Tri-Membrane Wrap™ VLU

OTHER

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

Other: Tri-Membrane Wrap™ VLU

Membrane Wrap™ VLU

OTHER

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

Other: Membrane Wrap™ VLU

Membrane Wrap-Lite™ VLU

OTHER

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

Other: Membrane Wrap-Lite™ VLU

Membrane Wrap-Hydro™ VLU

OTHER

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

Other: Membrane Wrap-Hydro™ VLU

Interventions

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.

Tri-Membrane Wrap™ DFU

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.

Membrane Wrap-Lite™ DFU

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.

Membrane Wrap-Hydro™ DFU

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.

Tri-Membrane Wrap™ VLU

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.

Membrane Wrap™ VLU

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.

Membrane Wrap-Lite™ VLU

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.

Membrane Wrap-Hydro™ VLU

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.

Membrane Wrap™ DFU

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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioLab Holdings: lead
• Serena Group: 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

1-833-865-6300; info@serenagroups.com

Thomas Serena, MD

CONTACT

1-833-865-6300; Info@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 follows a rescue design: patients in the SOC arm who fail to heal during the BIOCAMP Prospective Modified Dual Platform Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive one of the study products. Patients enrolled in this trial must still meet medical necessity criteria for cellular, acellular, matrix-like, products (CAMPs) recently published by the Medicare Administrative Contractor's (MAC) in their local coverage determinations (LCD).

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 23, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)