A RCT Evaluating Efficacy of Type-I Collagen Skin Substitute vs. Human Amnion Membrane in Treatment of Venous Leg Ulcers

Launched by DR NAVEEN NARAYAN MS, MCH (PLASTIC SURGERY) · Feb 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two treatments for venous leg ulcers, which are long-lasting sores caused by poor blood flow in the legs. The trial compares a Type-I Collagen Skin Substitute to a human amniotic membrane to see which one works better in helping these ulcers heal. The goal is to find out which treatment is safer and more effective for patients with these chronic wounds.

To participate in the study, individuals must be at least 18 years old and have a specific type of venous leg ulcer that has been present for at least 4 weeks. The ulcer must be in the foot, ankle, or lower leg and meet certain size requirements. Participants will need to visit the clinic regularly for treatment and follow-up. It's important to know that some people may not qualify for the study, especially those with infections, certain health conditions, or who are pregnant. Overall, this trial aims to improve treatment options for people suffering from venous leg ulcers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects must be at least 18 years of age or older.
• • 2. Subjects must have a diagnosis of a venous leg ulcer (confirmed by clinical and duplex ultrasound evaluation).
• • 3. At enrolment subjects must have a target VLU with a minimum surface area of 2.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement using a ruler to measure wound area.
• • 4. 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.
• • 5. The target ulcer must be located on the foot, ankle and lower leg region.
• • 6. The target ulcer must be full thickness on the foot or ankle that does not probe to bone.
• 7. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
• • i. TCOM ≥30 mmHg ii. ABI between 0.7 and 1.3 iii. PVR: Biphasic iv. TBI ˃0.6 v. As an alternative arterial, Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle of the target extremity.
• • h. 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.
• • i. The subject must consent to using the prescribed off-loading method for the duration of the study.
• • j. The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.
• • k. The subject must be willing and able to participate in the informed consent process.
• • l. Patients must have read and signed the IRB approved ICF before screening procedures are undertaken.
• Exclusion Criteria:
• • 1. A subject known to have a life expectancy of \<6 months
• • 2. If the target ulcer is infected or if there is cellulitis in the surrounding skin.
• • 3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
• • 4. A subject that has an infection in the target ulcer that requires systemic antibiotic therapy.
• • 5. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
• • 6. Topical application of steroids to the ulcer surface within one month of initial screening.
• • 7. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
• • 8. A subject with autoimmune or connective tissue disorders.
• • 9. A subject with malignant wounds or non-venous ulcers.
• • 10. A subject with a serum creatinine ≥ 3.0mg/dL within 6 months of the initial screening visit.
• • 11. Women who are pregnant or considering becoming pregnant within the next 6 months and those who are breast feeding.
• • 12. A subject with end stage renal disease requiring dialysis.
• • 13. A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
• • 14. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
• • 15. 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.
• • 16. History of autoimmune disease, malignancy, or uncontrolled diabetes (HbA1c \>10%).
• • 17. Allergy to components of High Purity Type-I Collagen-based Skin Substitute or Dehydrated Human Amnion/Chorion Membrane.