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

Part of paid clinical trials in Thousand Oaks, California.

Sponsor
Axolotl Biologix
Study ID
NCT06550596
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

Key Dates

Start date
Sep 23, 2024
Status verified
Jan 2025
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care
    Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.
  • Experimental: Axolotl DualGraft + SOC
    Axolotl DualGraft is a dehydrated human amnion membrane.

Primary Outcome Measure

Efficacy of dhAM + SOC vs SOC [ Time Frame: 1-12 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Performance Foot and Ankle SpecialistsThousand OaksCalifornia91320
Dr. Patel
[email protected]
805-380-3152

Find similar trials in Thousand Oaks, CA

By research site
Performance Foot and Ankle Specialists· Thousand Oaks, CA

Related Studies