Actively Recruiting
A Randomized Multicenter Clinical Trial Evaluating Dehydrated Human Amnion Membrane (dhAM) Plus Standard Care Versus Standard Care Alone in Nonhealing Diabetic Foot Ulcers
Led by Axolotl Biologix · Updated on 2025-01-30
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Axolotl Biologix
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of dehydrated human amnion membrane (dhAM) combined with standard care compared to standard care alone in healing nonhealing diabetic foot ulcers (DFUs). This multi-center randomized controlled trial aims to determine if adding dhAM helps close these ulcers more efficiently in people with diabetes. The study is sponsored by Axolotl Biologix and focuses on patients with specific ulcer characteristics and diabetes types 1 or 2. Participants will be randomly assigned to one of two groups: one receiving standard care alone, which includes cleaning, debridement, moisture balance, and offloading, and the other receiving weekly applications of Axolotl DualGraft (dhAM) plus standard care. Treatments will continue weekly until the ulcer closes or for a maximum of 12 weeks. The study will compare healing outcomes between these two approaches. During the study, participants will attend weekly visits for treatment and monitoring. Researchers will assess ulcer closure, time to healing, changes in ulcer size, and any adverse events over 1 to 12 weeks. Quality of life related to the wound will also be evaluated using questionnaires. The overall goal is to understand how the addition of dhAM affects healing and patient experience over the study period ending in October 2025.
CONDITIONS
Brief 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...
- Subjects must be at least 18 years of age or older.
- Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
- Subjects must have a target ulcer with a surface area between 1.0 cm2 and 5.0 cm2 measured after cleaning.
- The target ulcer must have been present for at least 4 weeks and no more than 52 weeks of standard care prior to screening.
- The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- The target ulcer must be Wagner grade 1 or 2, extending through dermis or subcutaneous tissue, possibly involving muscle but no exposed tendon or bone.
- The affected limb must have adequate blood flow confirmed by specific vascular tests performed within 3 months.
- If there are multiple ulcers, they must be separated by at least 2 cm, with the largest qualifying ulcer chosen.
- Participants must consent to using the prescribed offloading method during the study.
- Participants must agree to attend weekly study visits.
- Participants must be willing and able to give informed consent.
You will not qualify if you...
- Life expectancy less than 6 months.
- Target ulcer not caused by diabetes.
- Infected target ulcer or cellulitis in surrounding skin.
- Evidence of bone infection (osteomyelitis) at the ulcer site.
- Infection requiring systemic antibiotics.
- Use of immunosuppressants or chemotherapy.
- Topical steroids applied to ulcer within one month prior to screening.
- Previous partial foot amputation causing offloading issues.
- Ulcer surface area reduced by more than 20% in the 2 weeks before screening.
- Ulcer surface area reduced by 20% or more during the 2-week screening phase.
- Malnutrition with Mini Nutritional Assessment score below 17.
- Acute or inactive Charcot foot that impedes offloading.
- Women who are pregnant or planning pregnancy within 6 months.
- End stage renal disease requiring dialysis.
- Any medical or psychological condition interfering with study assessments.
- Treatment with hyperbaric oxygen or similar products within 30 days before screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive weekly treatment with standard of care or dehydrated human amnion membrane plus standard of care until ulcer closure or a maximum of 12 weeks, whichever occurs first.
Weekly visits for up to 12 weeks
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
T
Thomas Serena, MD
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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