Actively Recruiting
A Randomized Controlled Clinical Trial Evaluating The Efficacy of an Amnion Membrane Allograft Intended for Use in the Management of Non-Healing Venous Leg Ulcers Versus Standard Of Care Alone
Led by Skye Biologics Holdings, LLC · Updated on 2025-01-09
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare wound healing in patients with venous leg ulcers (VLUs) treated with two different dressing methods. It evaluates the percentage of wound closure when using E-GRAFT™, a dehydrated thick amniotic allograft, plus standard care (SOC) versus FIBRACOL™, a collagen alginate dressing plus SOC. The study also examines the rate of wound closure, changes in ulcer size over 12 weeks, pain levels, infection occurrence, and any side effects. Participants are randomly assigned to one of two groups: one group receives standard care with E-GRAFT™ as the primary dressing, while the other receives standard care with FIBRACOL™ as the primary dressing. Both dressings are used on venous leg ulcers that meet specific size and duration criteria. The study involves weekly visits and treatment over a 12-week period, during which the healing progress and safety are closely monitored. During the study, participants attend weekly visits for wound assessment and treatment. Researchers measure wound closure rates, time to healing, and changes in ulcer size. They also track pain, any infections, and adverse events. The primary outcome is the proportion of ulcers healed by 12 weeks. Participants must agree to use prescribed off-loading methods and compression therapy. The total participation duration is about 12 weeks, during which safety and healing are carefully observed.
CONDITIONS
Brief Title
Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be at least 18 years of age or older.
- Have a target ulcer with surface area between 1.0 cm² and 20.0 cm² measured after cleaning.
- The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard care before screening.
- If there are two or more ulcers, they must be at least 2 cm apart, with the largest ulcer selected as the target.
- Consent to use the prescribed off-loading method for the study duration.
- Agree to attend weekly study visits.
- Willing and able to participate in the informed consent process.
- The target ulcer must be full thickness on the foot or leg and not probe to bone.
- Adequate circulation to the affected foot confirmed by specified tests within 3 months of screening.
- Target ulcers must have been treated with compression therapy for at least 14 days prior to randomization.
You will not qualify if you...
- Life expectancy less than 6 months.
- Target ulcer is infected or there is cellulitis around the ulcer.
- Presence of osteomyelitis, exposed bone, or probes to bone or joint capsule.
- Use of immunosuppressants or cytotoxic chemotherapy.
- Topical steroid use on the ulcer within one month before screening.
- Previous partial amputation on the affected leg causing improper offloading.
- Diabetes with HbA1c greater than or equal to 12% within 3 months before screening.
- Serum creatinine 3.0 mg/dL or higher within 6 months before randomization.
- Ulcer size reduced by more than 30% during the 2-week screening phase.
- 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 product within 30 days before screening.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Weekly visits for up to 2 weeks
Duration - Up to 12 weeks
Participants receive standard of care treatment with either E-GRAFT™ or FIBRACOL™ dressings applied to their venous leg ulcers.
Weekly visits during treatment
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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