Exploring Safety and Effectiveness of HI-GRIP VC Bandage for Chronic Leg Ulcers
- Conditions
- Health Condition 1: L979- Non-pressure chronic ulcer of unspecified part of lower leg
- Registration Number
- CTRI/2024/07/070977
- Lead Sponsor
- Outcare Medical Device Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Men or women subjects aged greater than or equal to 18 with chronic venous leg ulcer based on either venous reflux or obstructive disease that has
been present for at least 4 weeks
An area equal to or greater than 1 cm2 but less than or equal to 20 cm2 as measured by 2D Mathematical model for simple wound measurement. The ulcer area was calculated using the formula Area equal to length multiplied by width multiplied by 0 point 73
Subjects with ABPI greater than or equal to 0 point 8
Venous ulcer area (greatest length by greatest width), following sharp debridement, of greater than or equal to 5 cm square
Subjects to be without compromising any arterial function
Women should agree to practice adequate contraception and have a negative pregnancy test at screening
Subjects who are mobile, and able to return for required treatments and study evaluations without undue hardship
Subject should be able to give informed consent
Subject should be able to understand and comply with the requirements of the study
Subjects with advanced peripheral obstructive arterial disease ABPI less than 0.8
Subjects with systemic arterial pressure less than 80 mm Hg at ankle
Subjects with Phlegmasia cerulea dolens
Subjects with Uncontrolled congestive heart failure
Subjects with Abscesses
Subjects with Septic phlebitis
Subjects with Advanced peripheral neuropathy
Subjects with insulin dependent diabetes mellitus and poorly controlled/uncontrolled diabetes mellitus with HbA1c greater than or equal to 7.5
Subjects with Anaemia Hb less than 10 g/dL
Subjects with CKD creatinine greater than 1point 5 mg/dL
Subjects with known allergy to any components of dressing or treatment during the study.
Subjects taking systemic corticosteroids.
Subjects involvement in another experimental drug study within a month prior to this study screening.
Subjects with clinical evidence of infection or cellulitis in or around any ulcer
Subjects any history of medical non ?compliance.
Subjects inability to understand the pilot study or provide written informed consent.
Pregnancy
Subjects with presence of peripheral arterial insufficiency, uncontrolled congestive heart failure vasculitis or severe contact dermatitis and
Any condition that the Principal Investigator deems/precludes the participant’s ability to complete the pilot study successfully and safely and/or that may confound study outcomes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To measure the efficacy of the HI-GRIP VC Advanced Compression Bandage in reducing the size of chronic venous leg ulcers, with the primary outcome being the decrease in wound dimensions, measured in centimetre (cm) over a specified period. <br/ ><br>Parameters to be assessed here is the wound size using Ulcer size measurements in 2D Mathematical model for simple wound measurement. <br/ ><br>Wound digital photographs.Timepoint: Planned study period is 7 months (1 month screening and recruitment period + 3 months <br/ ><br>treatment period + 1 Follow-up visit per month for 3 months) <br/ ><br>Baseline (Visit 1): Measure ulcer size, and capture digital images for initial dimensions. <br/ ><br>Treatment Visits (Visit 2-14): In every visit, we will monitor changes in ulcer size and take digital photos. <br/ ><br>Follow-up (Visit 15-17): Assess sustained changes post-treatment with size measurement and digital photography.
- Secondary Outcome Measures
Name Time Method