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)

February 5, 2026 updated by: BioLab Holdings
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philidelphia, Pennsylvania, United States, 19146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tri-Membrane Wrap™ DFU
Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane.
Other: 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.
Other: Membrane Wrap™ DFU
Membrane Wrap™ is an allograft derived from human amniotic membrane.
Other: 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.
Other: Membrane Wrap-Lite™ DFU
Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.
Other: 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.
Other: Membrane Wrap-Hydro™ DFU
Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.
Other: 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.
Other: Tri-Membrane Wrap™ VLU
Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane.
Other: 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.
Other: Membrane Wrap™ VLU
Membrane Wrap™ is an allograft derived from human amniotic membrane.
Other: 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.
Other: Membrane Wrap-Lite™ VLU
Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.
Other: 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.
Other: Membrane Wrap-Hydro™ VLU
Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Wound Closure
Time Frame: 1-12 Weeks
The percentage of target ulcers achieving complete wound closure in 12 weeks.
1-12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Closure
Time Frame: 1-12 weeks
Time to closure for the target ulcer.
1-12 weeks
Adverse Events
Time Frame: 1-12 Weeks
The number of product- or procedure- related adverse events.
1-12 Weeks
Percentage Area Reduction
Time Frame: 1-12 weeks
Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination.
1-12 weeks
Determine improvement in Quality of Life
Time Frame: 1-12 weeks
To determine the between-arm difference in the quality of life for subjects receiving HPM plus SOC compared to SOC alone using the Forgotten Wound Score (FWS) questionnaire. Forgotten wound scores situations on a scale of "never" to "mostly."
1-12 weeks
Determine improvement in Quality of Life
Time Frame: 1-12 weeks
To determine the between-arm difference in the quality of life for subjects receiving HPM plus SOC compared to SOC alone using the Wound Quality of Life (wQOL) questionnaire. Scores on a scare from "Not at all" to "Very much."
1-12 weeks
Pain in patients who present with VAS greater than 4
Time Frame: 1-12 Weeks
To determine the between-arm difference in pain for patients that present with a Visual Analog Sale (VAS) score of greater than 4. The VAS has a scale of 0-10. 0 Meaning no pain and 10 being the worst pain
1-12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioLab Holdings

Collaborators

Serena Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RescueX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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