Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone

Launched by SKYE BIOLOGICS HOLDINGS, LLC · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatments for patients with non-healing venous leg ulcers, which are sores that can be difficult to heal. The study will compare the use of a special product called E-GRAFT™ along with standard care to another product called FIBRACOL™ with standard care. Researchers want to see which treatment leads to better healing of the ulcers, how fast they heal, any side effects, changes in pain levels, and the risk of infection over a 12-week period.

To participate in this trial, you need to be at least 18 years old and have a leg ulcer that has been present for at least 4 weeks and is between 1.0 cm² and 20.0 cm² in size. You also need to be able to attend weekly visits during the study and follow specific care instructions. However, there are some important exclusions; for example, if you have an infection in the ulcer or certain other health conditions, you may not be eligible. If you decide to participate, you’ll be closely monitored and receive care to help improve your ulcer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects must be at least 18 years of age or older.
• • 2. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with manual measure.
• • 3. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
• • 4. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
• • 5. The subject must consent to using the prescribed off-loading method for the duration of the study.
• • 6. The subject must agree to attend the weekly study visits required by the protocol.
• • 7. The subject must be willing and able to participate in the informed consent process.
• • 8. The target ulcer must be full thickness on the foot or leg that does not probe to bone.
• 9. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
• • 1. TCOM ≥30 mmHg
• • 2. ABI between 0.7 and 1.3
• • 3. PVR: Biphasic
• • 4. TBI ˃0.6
• • 5. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle
• • 10. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
• • 11. Target ulcers must have been treated with compression therapy for at least 14 days prior to randomization.
• Exclusion Criteria:
• • 1. A subject known to have a life expectancy of \< 6 months is excluded.
• • 2. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
• • 3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
• • 4. Index ulcer and/or index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled
• • 5. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
• • 6. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
• • 7. A subject with a previous partial amputation on the affected leg is excluded if the resulting deformity impedes proper offloading of the target ulcer.
• • 8. If a subject is diabetic and has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he/she is excluded.
• • 9. If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomization he/she is excluded.
• • 10. The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1/randomization visit during which time the subject received SOC.
• • 11. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
• • 12. A potential subject with end stage renal disease requiring dialysis is excluded.
• • 13. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
• • 14. A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded