Health Condition 1: I872- Venous insufficiency (chronic) (peripheral)
Conditions
Interventions
Intervention1: SOC and High Purity Type-I Collagen-based Skin Substitute: The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as neede
Sponsors
Adichunchangiri University
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must be at least 18 years of age or older and 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.
Exclusion criteria
Exclusion criteria: If the target ulcer is infected or if there is cellulitis in the surrounding skin / presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator s exam or radiographic evidence or if an infection in the target ulcer that requires systemic antibiotic therapy are all excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage wound area reduction Description: Percentage wound area reduction from week 1 through week 6 measured manually with digital photographyTimepoint: Time Frame: 6 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Infiltration of vascularity in the ulcer bed Description: 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: (a) increase in number of blood vessels - as percentage change (b) increase in size of blood vessel - as percentage change Timepoint: Time Frame: 6 days;Time to achieve complete wound closure Description: The time to achieve complete wound closure of the target ulcer by the end of 6 weeksTimepoint: Time Frame: 6 weeks;Proportion of subjects to obtain complete closure Description: The proportion of subjects that obtain complete closure over the 6 week treatment periodTimepoint: Time Frame: 6 Weeks;Mean number of repeated application Description: Mean number of repeated applications of the Advanced Skin Substitute & Human Amnion/Chorion Membrane used to obtain wound closureTimepoint: Time Frame: 6 Weeks;Incidence of adverse events Description: Incidence of adverse events related to the intervention (e.g., infection, allergic reactions)Timepoint: Time Frame: 6 Weeks;Change in Pain Description: Change in pain measured by a Visual Analog Scale with score range from 0 to 10, wherein 0=no pain to 10=severe painTimepoint: Time Frame: 7 weeks including 1-week follow-up;Healed Wound appearance assessment using Manchester Scar Scale Description: The resultant new skin is assessed and documented at each visit using the Manchester Scar Scale assessing colour, finish, contour, distortion & texture with values given from 1 to 4 wherein 1 denotes excellent and 4 means poorTimepoint: Time Frame: 7 weeks including 1-week follow-up | — |
Countries
India
Contacts
Public ContactDr Naveen Narayan
Adichunchanagiri Institute of Medical Sciences
Outcome results
None listed