Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.

PHASE4RecruitingINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

December 6, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Venous Leg UlcerVenous LegDiabetic FootDiabetic Foot UlcerFoot Ulcer, DiabeticUlcer FootLeg UlcerUlcer VenousUlcer
Interventions
OTHER

ACApatch™

Participants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

caregraFT™

Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Standard of Care

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.

Trial Locations (1)

15146

RECRUITING

Serena Group, Monroeville

All Listed Sponsors
collaborator

SerenaGroup, Inc.

NETWORK

lead

Tiger Biosciences, LLC.

INDUSTRY