Single ?centre, Non ?randomised, Open ?label, Pilot study to determine the Safety and Efficacy of HI-GRIP VC Advanced Compression Bandage in subjects with Chronic Venous Leg Ulcer. - NI

Outcare Medical Device Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•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.
•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.

发起方

Outcare Medical Device Pvt Ltd