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. (BIORESCUE)

BioLab Holdings

Status and phase: Enrolling; Phase 4

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

Treatments: Other: Membrane Wrap™ DFU; Other: Membrane Wrap-Hydro™ VLU; Other: Tri-Membrane Wrap™ DFU; Other: Tri-Membrane Wrap™ VLU; Other: Membrane Wrap-Hydro™ DFU; Other: Membrane Wrap™ VLU; Other: Membrane Wrap-Lite™ DFU; Other: Membrane Wrap-Lite™ VLU

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07364630

To be determined

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
• 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.

Exclusion criteria

• 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.
• The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.
• The potential subject did not participate in the BIOCAMP trial.
• The potential subject participated in the BIOCAMP trial and was not randomized to the SOC only arm.
• The potential subject participated in the BIOCAMP trial and achieved complete closure.
• The target ulcer was treated with CAMPs, also defined as skin substitute, or hyperbaric oxygen therapy (HBOT) in the month prior to TV-1.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 8 patient groups

Tri-Membrane Wrap™ DFU

Other group

Description:

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

Treatment:

Other: Tri-Membrane Wrap™ DFU

Membrane Wrap™ DFU

Other group

Description:

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

Treatment:

Other: Membrane Wrap™ DFU

Membrane Wrap-Lite™ DFU

Other group

Description:

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

Treatment:

Other: Membrane Wrap-Lite™ DFU

Membrane Wrap-Hydro™ DFU

Other group

Description:

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

Treatment:

Other: Membrane Wrap-Hydro™ DFU

Tri-Membrane Wrap™ VLU

Other group

Description:

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

Treatment:

Other: Tri-Membrane Wrap™ VLU

Membrane Wrap™ VLU

Other group

Description:

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

Treatment:

Other: Membrane Wrap™ VLU

Membrane Wrap-Lite™ VLU

Other group

Description:

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

Treatment:

Other: Membrane Wrap-Lite™ VLU

Membrane Wrap-Hydro™ VLU

Other group

Description:

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

Treatment:

Other: Membrane Wrap-Hydro™ VLU