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

Not Applicable

Recruiting

• Conditions: Venous Leg Ulcers

• Registration Number: NCT06831760
• Lead Sponsor: Dr Naveen Narayan MS, MCh (Plastic Surgery)

Brief Summary

Venous leg ulcers are chronic wounds caused by venous insufficiency, leading to significant morbidity. The purpose of this randomized, controlled study is to evaluate the safety and efficacy of the application of Type-I Collagen-based Skin Substitute (HPTC) vs. Dehydrated Human Amnion/Chorion Membrane (dHCAM) in the treatment of VLUs and to compare their efficacy.

Detailed Description

Venous leg ulcers (VLUs) are chronic wounds caused by venous insufficiency, leading to significant morbidity. Current treatment options often include compression therapy, wound debridement, and advanced dressings. Despite advances in wound care, effective treatment remains challenging. The purpose of this randomized, controlled study is to evaluate the safety and efficacy of the application of Type-I Collagen-based Skin Substitute (HPTC) vs. Dehydrated Human Amnion/Chorion Membrane (dHCAM) in the treatment of VLUs and to compare the efficacy of these two advanced wound care modalities in accelerating VLU healing.

Study Timeline

• Study First Submitted: 2025-01-27
• Status Verified: 2025-02
• Study Start: 2025-02-01
• Study First Submitted QC: 2025-02-16
• Last Update Submitted: 2025-02-16
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage wound area reduction	6 Weeks	Percentage wound area reduction from week 1 through week 6 measured manually with digital photography

Secondary Outcome Measures

Name	Time	Method
Infiltration of vascularity in the ulcer bed	6 days	Infiltration of vascularity in the ulcer bed on day 5 of application. Vascularity assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Subsequently histopathology of biopsy will be done to look for: 1. increase in number of blood vessels - as percentage change; 2. increase in size of blood vessel - as percentage change
Time to achieve complete wound closure	6 weeks	The time to achieve complete wound closure of the target ulcer by the end of 6 weeks
Proportion of subjects to obtain complete closure	6 Weeks	The proportion of subjects that obtain complete closure over the 6 week treatment period
Mean number of repeated application	6 Weeks	Mean number of repeated applications of the Advanced Skin Substitute \& Human Amnion/Chorion Membrane used to obtain wound closure
Incidence of adverse events	6 Weeks	Incidence of adverse events related to the intervention (e.g., infection, allergic reactions)

Trial Locations

Locations (1)

Adichunchanagiri Institute of Medical Sciences; 🇮🇳 Mandya, Karnataka, India