A study to check the effect of wound dressing in long standing wounds of leg

Phase 4

Conditions: Health Condition 1: L979- Non-pressure chronic ulcer of unspecified part of lower leg

Registration Number: CTRI/2023/02/049571

Lead Sponsor: Dr Sanjay Sharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Male and female patients aged above 18 years with <= 3 wounds in the lower extremity considered for the study

2. Patient with a low to moderate exuding lower extremity wound with size <= 8 cm Ã? 8 cm, with less than 50% of contraction in the past 4 weeks even after standard treatment

3. Patient willing to give written informed consent and adhere to study procedures

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) < 0.7

10. Pregnant or lactating mothers

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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