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

NARecruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

November 18, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

August 31, 2026

Conditions
Diabetic Foot UlcerVenous Leg Ulcer
Interventions
DEVICE

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

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.

DEVICE

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

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.

DEVICE

AmnioExcel Plus for Venous Leg Ulcers

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.

DEVICE

AmnioExcel Plus for Diabetic Foot Ulcers

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.

PROCEDURE

Standard of Care

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.

Trial Locations (12)

11042

RECRUITING

Comprehensive Wound Healing Center, Northwell Health, Lake Success

15146

ENROLLING_BY_INVITATION

SerenaGroup, Monroeville

20010

RECRUITING

Medstar Washington Hospital Center (MWHC), Washington D.C.

32223

ENROLLING_BY_INVITATION

Symphony Research, Jacksonville

32792

TERMINATED

Health Goods Management, LLC, Winter Park

33321

ENROLLING_BY_INVITATION

Barry University Clinical Research, Tamarac

33564

ENROLLING_BY_INVITATION

Denali Health Plant City, LLC, Plant City

60169

ENROLLING_BY_INVITATION

Midwest Foot and Ankle Clinics, Hoffman Estates

67756

ENROLLING_BY_INVITATION

Cheyenne County Hospital, Saint Francis

90010

ENROLLING_BY_INVITATION

Angel City Research, Los Angeles

93301

ENROLLING_BY_INVITATION

Phase One Clinical Trials, Inc., Bakersfield

94115

ENROLLING_BY_INVITATION

Center for Clinical Research, San Francisco

All Listed Sponsors
collaborator

SerenaGroup, Inc.

NETWORK

lead

Integra LifeSciences Corporation

INDUSTRY

NCT06453187 - A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers | Biotech Hunter | Biotech Hunter