Health Condition 1: L979- Non-pressure chronic ulcer of unspecified part of lower leg
Conditions
Interventions
Intervention1: 3D hydrocellular dressing pad: 3D hydrocellular dressing pad is made of Polyethylene terephthalate (PET), polyurethane (PU) and Dimethyl Tetradecyl [3(trimethoxysily) propyl] ammonium c
Sponsors
Dr Sanjay Sharma
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged above 18 years with 2. Patient with a low to moderate exuding lower extremity wound with size 3. Patient willing to give written informed consent and adhere to study procedures
Exclusion criteria
Exclusion criteria: 1. Patients with wounds caused by venous or arterial insufficiency, or electrical or chemical burns 2. Patients with wounds showing presence of necrosis, purulence or sinus tracts that cannot be removed by debridement 3. Patients with history of active Charcoatâ??s foot of the study foot within 6 months of screening 4. Patients with severe or poorly controlled diabetes mellitus with severe hyperglycaemia (HbA1C >12%) 5. Patients with progressive weight loss 6. Patients undergoing treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, or radiotherapy 7. Patients with history of other diseases, which can alter the normal healing of the wound such as connective tissue disease, renal failure, liver failure, and malignancy 8. Patients who underwent revascularization surgery in the last 8 weeks 9. Patients with ankle-brachial index(ABI) 10. Pregnant or lactating mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of wound contraction as calculated by using the initial and final area every week for 8 weeks by using graded sterile centimeter ruler sterile scaleTimepoint: Day 7, 14, 21, 28, 35, 42, 49 & 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject satisfaction of wound healing using 5-point scaleTimepoint: Day 7, 14, 21, 28, 35, 42, 49 & 56;To assess adverse eventsTimepoint: Day 7, 14, 21, 28, 35, 42, 49 & 56;Visual analogue scale (VAS) is used to assess pain every week during dressing pad removalTimepoint: Day 7, 14, 21, 28, 35, 42, 49 & 56;Wound dimensions, wound edge, type of tissue in the wound bed, the depth of the wound, exudate of the wound, Peri-wound skin and presence of infection/inflammation will be assessed by using RESVECH 2.0 scaleTimepoint: Day 1, 7, 14, 21, 28, 35, 42, 49 & 56;Wound360 version 1.1 application is used for wound characterization and photographyTimepoint: Day 1, 7, 14, 21, 28, 35, 42, 49 & 56 | — |
Countries
India
Contacts
Public ContactDr Sanjay Sharma
FootSecure clinic
Outcome results
None listed