Actively Recruiting
A Randomized Controlled Clinical Trial Evaluating The Efficacy of an Amnion Membrane Allograft Intended for Use in the Management of Non-Healing Diabetic Foot Ulcers Versus Standard Of Care Alone
Led by Skye Biologics Holdings, LLC · Updated on 2025-01-10
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two treatments for diabetic foot ulcers (DFUs) to see which is more effective in helping wounds heal. This study compares wound healing rates between patients treated with E-GRAFT™, a dehydrated amniotic membrane allograft, and those treated with FIBRACOL™, a collagen alginate dressing, both combined with standard care. The study aims to measure wound closure rates, ulcer size changes, nerve damage, pain levels, and infections over 12 weeks. Participants are randomly assigned to receive either E-GRAFT™ or FIBRACOL™ as their primary dressing along with standard care. The E-GRAFT™ is a human tissue product approved by the FDA, while FIBRACOL™ is a cleared collagen-based dressing. Both treatments are applied over a 12-week period. Patients must follow offloading methods for ulcers on the plantar foot and attend weekly visits throughout the study. During the trial, participants will have weekly visits to monitor wound healing, pain, nerve function, and any side effects or infections. Measurements include the proportion of ulcers completely healed at 12 weeks and the time taken for healing. Researchers will also track changes in ulcer size and neuropathy. The study lasts for at least 12 weeks, with detailed assessments to understand each treatment's impact on wound healing and related factors.
CONDITIONS
Brief Title
Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years old or older
- Have a diagnosis of type 1 or type 2 Diabetes mellitus
- Have a target diabetic foot ulcer with surface area between 1.0 cm2 and 10.0 cm2 after debridement
- Ulcer present for at least 4 weeks and no longer than 52 weeks of standard care before screening
- Ulcer located on foot with at least 50% below the ankle bone (malleolus)
- Ulcer must be full thickness on foot or ankle and not probe to bone
- Have adequate circulation to the affected foot documented by specific vascular tests within 3 months
- If multiple ulcers, target ulcer must be largest and at least 2 cm apart from others
- For ulcers on the foot sole, must have offloaded ulcer for at least 14 days before randomization
- Agree to use prescribed off-loading method during the study
- Agree to attend weekly study visits
- Be willing and able to participate in informed consent process
You will not qualify if you...
- Life expectancy less than 6 months
- Infected target ulcer or cellulitis in surrounding skin
- Osteomyelitis or exposed bone or joint capsule in ulcer area
- Receiving immunosuppressants or high-dose corticosteroids or cytotoxic chemotherapy
- Topical steroid use on ulcer within 1 month before screening
- Previous partial amputation on affected foot causing offloading problems
- HbA1c equal to or above 12% within 3 months before screening
- Serum creatinine 3.0 mg/dL or higher within 6 months before randomization
- Ulcer surface area reduced by more than 30% during 2-week screening phase
- Acute or inactive Charcot foot impeding proper offloading
- Women who are pregnant or planning pregnancy within 6 months
- End stage renal disease requiring dialysis
- Medical or psychological conditions interfering with study assessments
- Treatment with hyperbaric oxygen therapy or cellular/tissue 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 standard of care dressing with either E-GRAFT™ or FIBRACOL™ applied to their diabetic foot ulcers.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Professional Education and Research Institute
Roanoke, Virginia, United States, 24016
Actively Recruiting
Research Team
A
Adam Isaac, DPM
M
Melissa Crosswhite
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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