Actively Recruiting
Clinical Trial Evaluating 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
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with SOC versus FIBRACOL™ with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse events or reactions (side effects) * Change in pain levels * Occurrence of infection
CONDITIONS
Official 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...
- Must be 18 years of age or older
- Have a target ulcer with a surface area between 1.0 cm2 and 20.0 cm2 after cleaning
- The target ulcer must have been present for at least 4 weeks and no more than 52 weeks of standard care before screening
- If multiple ulcers are present, they must be at least 2 cm apart; the largest qualifying ulcer will be the target ulcer
- Agree to use the prescribed off-loading method for the study duration
- Agree to attend weekly study visits as required by the protocol
- Willing and able to participate in the informed consent process
- The target ulcer must be a full thickness wound on the foot or leg that does not probe to bone
- Have adequate blood circulation to the affected foot as shown by tests within 3 months before screening (such as TCOM 60;30 mmHg, ABI between 0.7 and 1.3, biphasic PVR, TBI 0.6, or arterial Doppler ultrasound)
- Target ulcers must have received compression therapy for at least 14 days before randomization
You will not qualify if you...
- Life expectancy less than 6 months
- Target ulcer is infected or has cellulitis in surrounding skin
- Presence of osteomyelitis or exposed bone, or ulcer probes to bone or joint capsule
- Active infection of the index ulcer or limb not adequately treated
- Receiving immunosuppressants or cytotoxic chemotherapy (including systemic corticosteroids over 10 mg prednisone daily)
- Topical steroid application to ulcer surface within one month before screening
- Previous partial amputation on affected leg causing difficulty with off-loading
- Diabetic with HbA1c greater than or equal to 12% within 3 months before screening
- Serum creatinine greater than or equal to 3.0 mg/dL within 6 months before randomization
- Target ulcer size reduced by more than 30% during the 2 weeks before screening
- 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
- Treated with hyperbaric oxygen therapy or Cellular/Tissue Product within 30 days before screening
AI-Screening
AI-Powered Screening
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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
CONTACT
M
Melissa Crosswhite
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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