Actively Recruiting
Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
Led by Axolotl Biologix · Updated on 2025-01-30
100
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
Sponsors
A
Axolotl Biologix
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Diagnosis of type 1 or 2 diabetes mellitus
- Target foot ulcer with surface area between 1.0 and 5.0 cm² after debridement
- Ulcer present for 4 to 52 weeks under standard care prior to screening
- Ulcer located on the foot with at least 50% below the malleolus
- Ulcer classified as Wagner grade 1 or 2, extending through dermis or subcutaneous tissue, possibly involving muscle but no exposed tendon or bone
- Adequate blood flow in affected limb confirmed by vascular assessment within 3 months
- If multiple ulcers, at least 2 cm apart; largest eligible ulcer chosen as target
- Willing to use prescribed offloading method during study
- Agree to attend weekly study visits
- Able and willing to provide informed consent
You will not qualify if you...
- Life expectancy less than 6 months
- Ulcer not caused by diabetes
- Infected target ulcer or surrounding skin cellulitis
- Osteomyelitis affecting the target ulcer
- Infection requiring systemic antibiotics
- Use of immunosuppressants or high-dose corticosteroids or cytotoxic chemotherapy
- Topical steroid use on ulcer within one month prior to screening
- Prior partial amputation on affected foot that prevents proper offloading
- Ulcer size reduced by more than 20% in the 2 weeks before screening
- Ulcer size reduced by 20% or more during the 2-week screening phase
- Malnutrition with Mini Nutritional Assessment score below 17
- Acute or inactive Charcot foot impairing offloading
- Pregnancy or planning pregnancy within 6 months
- End stage renal disease requiring dialysis
- Medical or psychological conditions interfering with study assessments
- Treatment with hyperbaric oxygen or cellular/acellular/matrix products within 30 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Performance Foot and Ankle Specialists
Thousand Oaks, California, United States, 91320
Actively Recruiting
Research Team
B
Bennett M Rogers
CONTACT
T
Thomas Serena, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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