Recruiting

Placental Membrane Products

Sponsor:

BioLab Holdings

Code:

NCT07364630

Conditions

Diabetic Foot Ulcer

Foot Ulcer Chronic

DFU

Ulcer Foot

Venous Leg Ulcer (VLU)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tri-Membrane Wrap™ DFU

Membrane Wrap™ DFU

Membrane Wrap-Lite™ DFU

Membrane Wrap-Hydro™ DFU

Tri-Membrane Wrap™ VLU

Study Details

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)

Study ID

NCT07364630

Start date

Jan 2, 2026

Status verified date

Feb, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Tri-Membrane Wrap™ DFU

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

other: Membrane Wrap™ DFU

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

other: Membrane Wrap-Lite™ DFU

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

other: Membrane Wrap-Hydro™ DFU

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

other: Tri-Membrane Wrap™ VLU

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

other: Membrane Wrap™ VLU

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

other: Membrane Wrap-Lite™ VLU

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

other: Membrane Wrap-Hydro™ VLU

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

Interventions

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.

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.

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.

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.

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.

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.

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.

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.

Primary outcome measure

  • Percentage of Wound Closure [ Time Frame: 1-12 Weeks ]

Central Contacts and Locations

Central contacts

Bennett Sarver

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

Thomas Serena, MD

1-833-865-6300Info@serenagroups.com

Locations

Center for Foot and Ankle Disorders

Recruiting

Philidelphia, Pennsylvania, United States, 19146

Contacts

Ryan Breisinger

412-965-5737rbreisinger@serenagroups.com

More Information

Sponsor

BioLab Holdings

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BioLab Holdings on 2026-02-09.