Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 23, 2024

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Diabetic FootUlcer FootFoot UlcerDiabetic Foot Ulcer
Interventions
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.

OTHER

Axolotl DualGraft + SOC

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

Trial Locations (1)

91320

RECRUITING

Performance Foot and Ankle Specialists, Thousand Oaks

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

SerenaGroup, Inc.

NETWORK

lead

Axolotl Biologix

INDUSTRY

NCT06550596 - Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers | Biotech Hunter | Biotech Hunter