A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers

NCT06453187 | Enrolling By Invitation FDA Device

• 1 other identifier: T-WOUNDS-001
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal diabetic foot and venous leg ulcers.

Conditions

Diabetic Foot Ulcer; Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Percentage of complete wound closure for target ulcer

  The percentage of target ulcers, DFU and VLU, achieving complete wound closure Complete wound closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate

  1-12 weeks

Secondary Outcomes (6)

• Time to complete wound closure for target ulcer

  1-12 weeks

• Percentage of wound area reduction for target ulcer

  1-12 weeks

• Adverse Events

  1-14 weeks

• Changes to pain associated with the target ulcer

  1-14 weeks

• Determine improvement in Quality of Life

  1-14 weeks

Study Arms (5)

Venous Leg Ulcers with a Urinary Bladder Matrix (UBM) sheet device

EXPERIMENTAL

Participants will receive treatment with Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Device: Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers; Procedure: Standard of Care

Diabetic Foot Ulcers with Urinary Bladder Matrix (UBM) sheet device

EXPERIMENTAL

Participants will receive treatment with Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Device: Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers; Procedure: Standard of Care

Venous Leg Ulcers with AmnioExcel Plus

EXPERIMENTAL

Participants will receive treatment with AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Device: AmnioExcel Plus for Venous Leg Ulcers; Procedure: Standard of Care

Diabetic Foot Ulcers with AmnioExcel Plus

EXPERIMENTAL

Participants will receive treatment with AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Device: AmnioExcel Plus for Diabetic Foot Ulcers; Procedure: Standard of Care

Standard of Care

ACTIVE COMPARATOR

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Procedure: Standard of Care

Interventions

Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers DEVICE

Application of Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Venous Leg Ulcers with a Urinary Bladder Matrix (UBM) sheet device

AmnioExcel Plus for Diabetic Foot Ulcers DEVICE

Application of AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Diabetic Foot Ulcers with AmnioExcel Plus

Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers DEVICE

Application of Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Diabetic Foot Ulcers with Urinary Bladder Matrix (UBM) sheet device

AmnioExcel Plus for Venous Leg Ulcers DEVICE

Application of AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Venous Leg Ulcers with AmnioExcel Plus

Standard of Care PROCEDURE

Participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Diabetic Foot Ulcers with AmnioExcel Plus; Diabetic Foot Ulcers with Urinary Bladder Matrix (UBM) sheet device; Standard of Care; Venous Leg Ulcers with AmnioExcel Plus; Venous Leg Ulcers with a Urinary Bladder Matrix (UBM) sheet device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be at least 21 years of age or older.
• Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
• At Screening Visit 1 and at Randomization, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.
• The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
• The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
• The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the malleolus.
• The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
• ABI between 0.7 and 1.3;
• TBI greater or equal to 0.6;
• TCOM greater or equal to 40 mmHg;
• PVR: biphasic.

You may not qualify if:

• Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
• 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 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, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
• The target ulcer exposes tendon or bone.
• There is evidence of osteomyelitis complicating the target ulcer.
• 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 Pl believes will interfere with wound healing such as biologics (monoclonal antibodies, therapeutic proteins and enzymes, gene therapies, cell therapies, cytokines and growth factors and certain vaccines) - Refer to Appendix N for a list of medications .
• The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
• The potential subject has 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.
• Nonapplicable in this protocol version.
• The surface area measurement of the Target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• SerenaGroup, Inc.: collaborator

Study Sites (12)

Phase One Clinical Trials, Inc.

Bakersfield, California, 93301, United States

Location

Angel City Research

Los Angeles, California, 90010, United States

Location

Center for Clinical Research

San Francisco, California, 94115, United States

Location

Alma Medical and Research Services, LLC

Hollywood, Florida, 33021, United States

Location

Symphony Research

Jacksonville, Florida, 32223, United States

Location

Denali Health Plant City, LLC

Plant City, Florida, 33564, United States

Location

Barry University Clinical Research

Tamarac, Florida, 33321, United States

Location

Denali Health

Atlanta, Georgia, 30083, United States

Location

SitePath Research

Evergreen Park, Illinois, 60805, United States

Location

Midwest Foot and Ankle Clinics

Hoffman Estates, Illinois, 60169, United States

Location

Comprehensive Wound Healing Center, Northwell Health

Lake Success, New York, 11042, United States

Location

SerenaGroup

Monroeville, Pennsylvania, 15146, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Tomas Serena, MD

  SerenaGroup, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 11, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)