350
Participants
Start Date
November 18, 2024
Primary Completion Date
June 30, 2026
Study Completion Date
August 31, 2026
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.
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.
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.
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.
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.
RECRUITING
Comprehensive Wound Healing Center, Northwell Health, Lake Success
ENROLLING_BY_INVITATION
SerenaGroup, Monroeville
RECRUITING
Medstar Washington Hospital Center (MWHC), Washington D.C.
ENROLLING_BY_INVITATION
Symphony Research, Jacksonville
TERMINATED
Health Goods Management, LLC, Winter Park
ENROLLING_BY_INVITATION
Barry University Clinical Research, Tamarac
ENROLLING_BY_INVITATION
Denali Health Plant City, LLC, Plant City
ENROLLING_BY_INVITATION
Midwest Foot and Ankle Clinics, Hoffman Estates
ENROLLING_BY_INVITATION
Cheyenne County Hospital, Saint Francis
ENROLLING_BY_INVITATION
Angel City Research, Los Angeles
ENROLLING_BY_INVITATION
Phase One Clinical Trials, Inc., Bakersfield
ENROLLING_BY_INVITATION
Center for Clinical Research, San Francisco
Lead Sponsor
SerenaGroup, Inc.
NETWORK
Integra LifeSciences Corporation
INDUSTRY