Recruiting

Placental Allograft

Sponsor:

Applied Biologics, LLC

Code:

NCT07159282

Conditions

Diabetic Foot

Foot Ulcer

Ulcer Foot

DFU

Foot Ulcer Due to Type 2 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

XWRAP

Study Details

Brief summary:

A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.

Conditions

Diabetic Foot

Foot Ulcer

Ulcer Foot

DFU

Foot Ulcer Due to Type 2 Diabetes Mellitus

Study ID

NCT07159282

Start date

Aug 26, 2025

Status verified date

Aug, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 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 CAMPX 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 CAMPX 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 has applied topical steroids to the ulcer surface within one month of initial screening.
  • 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 the initial screening visit.
  • 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 CAMPX trial.
  • The potential subject participated in the CAMPX trial and was not randomized to the SOC only arm.
  • The potential subject participated in the CAMPX trial and achieved complete closure.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: XWRAP

Single-layer amniotic membrane + standard of care.

Interventions

XWRAP

Application of XWRAP + standard of care for up to 12 weeks.

Primary outcome measure

  • 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

Royal Research

Recruiting

Hollywood, Florida, United States, 33024

Contacts

Yaliliy Perez

954-940-0208yalilyp@royalresearchcorp.com

More Information

Sponsor

Applied Biologics, LLC

Last update posted

Feb 11, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Applied Biologics, LLC on 2026-02-11.