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

NCT07159282 | Recruiting Phase 4

• 1 other identifier: RescueX
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 1 Diabetes Mellitus; Diabetic Foot Ulcer; Foot Ulcer Due to Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Wound Closure

  The percentage of target ulcers achieving complete wound closure in 12 weeks.

  1-12 Weeks

Secondary Outcomes (6)

• Time to Closure

  1-12 weeks

• Wound Area Reduction

  1-12 weeks

• Adverse Events

  1-12 Weeks

• Wound Quality of Life

  1-12 weeks

• Forgotten Wound Score

  1-12 weeks

Study Arms (1)

XWRAP

EXPERIMENTAL

Single-layer amniotic membrane + standard of care.

Other: XWRAP

Interventions

XWRAP OTHER

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

XWRAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Applied Biologics, LLC: lead
• SerenaGroup, Inc.: collaborator

Study Sites (1)

Royal Research

Hollywood, Florida, 33024, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases

Central Study Contacts

Bennett Sarver

CONTACT

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

Thomas Serena, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study follows a rescue design: patients in the SOC arm who fail to heal during the CAMPX Prospective Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive the study product.

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)