Diabetic Foot UlcerBIORESCUENCT07364630
Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
A study testing Tri-Membrane Wrap™ DFU, Membrane Wrap™ DFU and Membrane Wrap-Lite™ DFU in people with Diabetic Foot Ulcer and Foot Ulcer Chronic, run by BioLab Holdings at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Foot Ulcer Chronic, DFU
- What is being tested?
- Tri-Membrane Wrap™ DFU, Membrane Wrap™ DFU and Membrane Wrap-Lite™ DFU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2026to Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Foot and Ankle Disorders
Philidelphia, Pennsylvania, 19146
Ryan Breisinger, 412-965-5737, rbreisinger@serenagroups.com
About this study
Official title: 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
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.
Read the 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).
- Conditions
- Diabetic Foot Ulcer, Foot Ulcer Chronic, DFU, Ulcer Foot, Venous Leg Ulcer (VLU), Venous Leg Ulcer
- Being tested
- Tri-Membrane Wrap™ DFU, Membrane Wrap™ DFU, Membrane Wrap-Lite™ DFU, Membrane Wrap-Hydro™ DFU, Tri-Membrane Wrap™ VLU
- Keywords
- Leg Ulcer, Ulcer, Venous Ulcer, Venous Leg ulcer, VLU, DFU, Diabetic Foot Ulcer, Foot Ulcer, Diabetic foot
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Varicose Ulcer, Leg Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-Membrane Wrap™ DFUOther
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™ DFUOther
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™ DFUOther
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™ DFUOther
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.
Tri-Membrane Wrap™ VLUOther
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™ VLUOther
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™ VLUOther
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™ VLUOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tri-Membrane Wrap™ DFU | Other | Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane. Receives: Other: Tri-Membrane Wrap™ DFU |
| Membrane Wrap™ DFU | Other | Membrane Wrap™ is an allograft derived from human amniotic membrane. Receives: Other: Membrane Wrap™ DFU |
| Membrane Wrap-Lite™ DFU | Other | Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane. Receives: Other: Membrane Wrap-Lite™ DFU |
| Membrane Wrap-Hydro™ DFU | Other | Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane. Receives: Other: Membrane Wrap-Hydro™ DFU |
| Tri-Membrane Wrap™ VLU | Other | Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane. Receives: Other: Tri-Membrane Wrap™ VLU |
| Membrane Wrap™ VLU | Other | Membrane Wrap™ is an allograft derived from human amniotic membrane. Receives: Other: Membrane Wrap™ VLU |
| Membrane Wrap-Lite™ VLU | Other | Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane. Receives: Other: Membrane Wrap-Lite™ VLU |
| Membrane Wrap-Hydro™ VLU | Other | Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane. Receives: Other: Membrane Wrap-Hydro™ VLU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Wound Closure
The percentage of target ulcers achieving complete wound closure in 12 weeks.
Measured: 1-12 Weeks
Secondary outcomes (6)
Time to Closure
Time to closure for the target ulcer.
Measured: 1-12 weeks
Percentage Area Reduction
Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination.
Measured: 1-12 weeks
Adverse Events
The number of product- or procedure- related adverse events.
Measured: 1-12 Weeks
Determine improvement in Quality of Life
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."
Measured: 1-12 weeks
Determine improvement in Quality of Life
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."
Measured: 1-12 weeks
Pain in patients who present with VAS greater than 4
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
Measured: 1-12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start2 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioLab Holdings
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364630
- Sponsor's protocol ID
- RescueX
- Acronym
- BIORESCUE
- Status last verified
- Feb 2026
- First submitted
- 16 Jan 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No