177
Participants
Start Date
December 20, 2024
Primary Completion Date
November 22, 2026
Study Completion Date
January 22, 2027
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 12 weeks, whichever occurs first.
AM/Single - DFU
Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
AM/Double - DFU
Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
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 12 weeks, whichever occurs first.
AM/Single - VLU
Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
AM/Double - VLU
Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
RECRUITING
Poirot Podiatry, Metairie
Lead Sponsor
SerenaGroup, Inc.
NETWORK
C5 Biomedical
INDUSTRY