Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs

NARecruitingINTERVENTIONAL
Enrollment

324

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Diabetic Foot UlcerVenous Leg UlcerUlcer FootLeg Ulcer
Interventions
OTHER

Standard of Care-DFU

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 13 weeks, whichever occurs first.

OTHER

AmnioCore - DFU

Participants will receive weekly applications of AmnioCore and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.

OTHER

Amnio Quad-Core - DFU

Participants will receive weekly applications of Amnio Quad-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.

OTHER

Standard of Care-VLU

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.

OTHER

Amnio Tri-Core - VLU

Participants will receive weekly applications of Amnio Tri-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.

OTHER

AmnioCore Pro

Participants will receive weekly applications of AmnioCore Pro and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.

OTHER

Amniocore Pro +

Participants will receive weekly applications of Amniocore Pro + and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.

Trial Locations (1)

43113

RECRUITING

Cutting Edge Research, Circleville

Sponsors
All Listed Sponsors
collaborator

SerenaGroup, Inc.

NETWORK

lead

Stability Biologics

INDUSTRY

NCT06560502 - Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs | Biotech Hunter | Biotech Hunter