Health Condition 1: L979- Non-pressure chronic ulcer of unspecified part of lower leg
Conditions
Interventions
Intervention1: HI-GRIP VC ADVANCED COMPRESSION BANDAGE: The HI-GRIP VC Advanced Compression Bandage is primarily intended to aid in wound management and support wound healing processes, in the treatme
Sponsors
Outcare Medical Device Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Parameters to be assessed here is the wound size using Ulcer size measurements in 2D Mathematical model for simple wound measurement. Wound digital photographs.Timepoint: Planned study period is 7 months (1 month screening and recruitment period + 3 months treatment period + 1 Follow-up visit per month for 3 months) Baseline (Visit 1): Measure ulcer size, and capture digital images for initial dimensions. Treatment Visits (Visit 2-14): In every visit, we will monitor changes in ulcer size and take digital photos. Follow-up (Visit 15-17): Assess sustained changes post-treatment with size measurement and digital photography. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of HI-GRIP VC Advanced Compression Bandage Therapy in subjects with chronic venous leg ulcers, as assessed by changes in the Revised Venous Clinical Severity Score (VCSS), the parameters are pain, varicose veins, venous edema, skin hyperpigmentation, inflammation, induration, number of ulcers, durations of ulcers, size of ulcers, & compliance with compression therapy.Timepoint: Time points utilized to achieve the secondary outcome is from the baseline visit to follow up visit. Baseline (Visit 1): Administer Revised VCSS to establish baseline severity score. Treatment Visits (Visit 2-14): Monitor changes in Revised VCSS to evaluate safety throughout treatment. Follow-up (Visit 15-17): Continue assessing Revised VCSS for any post-treatment changes in venous clinical severity.;To evaluate the safety of HI-GRIP VC Advanced Compression Bandage Therapy in subjects with chronic venous leg ulcers, as assessed by changes in the Revised Venous Clinical Severity Score (VCSS)Timepoint: Baseline (Visit 1): Administer Revised VCSS to establish baseline severity score. Treatment Visits (Visit 2-14): Monitor changes in Revised VCSS to evaluate safety throughout treatment. Follow-up (Visit 15-17): Continue assessing Revised VCSS for any post-treatment changes in venous clinical severity. | — |
Countries
India
Contacts
Public ContactAnuradha Akunuri
Outcare Medical Device Pvt Ltd
Outcome results
None listed