A RCT Evaluating Efficacy of Type-I Collagen Skin Substitute vs. Human Amnion Membrane in Treatment of Venous Leg Ulcers
Venous Leg Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT06831760 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SOC and Type-I Collagen-based Skin Substitute (Device); SOC and Human Amnion/Chorion Membrane (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dr Naveen Narayan MS, MCh (Plastic Surgery)
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Wound Area Change |
78.9; 65.4 | — |
| PRIMARY Histopathological Parameters - Vascular Infiltration |
2.73; 1.87 | — |
| PRIMARY Histopathological Parameters - Neo-epithelialization |
2.67; 1.63 | — |
| PRIMARY Histopathological Parameters - Fibroblast Activity |
2.80; 1.93 | — |
| PRIMARY Histopathological Parameters - Capillary Density |
47.3; 28.7 | — |
| PRIMARY Histopathological Parameters - Inflammatory Response |
1.23; 2.17 | — |
| PRIMARY Histopathological Parameters - Collagen Deposition |
2.63; 1.77 | — |
| SECONDARY Time to Achieve Complete Wound Closure |
42.6; 46.2 | — |
| SECONDARY Percentage of Subjects to Obtain Complete Closure |
21; 13 | — |
| SECONDARY Number of Patients Requiring Repeated Application |
8; 13 | — |
| SECONDARY Intervention Related Adverse Events |
28; 27; 2; 3; 0; 0 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- Subjects must be at least 18 years of age or older.
- Subjects must have a diagnosis of a venous leg ulcer (confirmed by clinical and duplex ultrasound evaluation).
- 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.
- 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.
- The target ulcer must be located on the foot, ankle and lower leg region.
- The target ulcer must be full thickness on the foot or ankle that does not probe to bone.
- 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
- A subject known to have a life expectancy of 10%).
- Allergy to components of High Purity Type-I Collagen-based Skin Substitute or Dehydrated Human Amnion/Chorion Membrane.
Data sourced from ClinicalTrials.gov (NCT06831760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.