STRIDE â?? Study of the effect of Topical waRm oxygen In treatment of Diabetic foot ulcEr - STRIDE

Yostra Labs Private Limited0 个研究点目标入组 20 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1) Subject has a documented diagnosis of Diabetes mellitus â?? Type 1 or type 2
•2) Leg ulcers with duration of more than 6 weeks but no longer than 1 year
•3) Wound type â?? Chronic wound ulcer, Wagner-Meggit Grade 2, 3
•4) Wound size range: greater than or equal to 25 sq. cm and less than or equal to 150 sq. cm
•5) In case of multiple ulcers, only the largest is considered in the study (index ulcer)
•6) Index ulcer must be greater than or equal to 1 cm away from any other ulcers present on the foot
•7) Adequate perfusion with ABI greater than 0.7

•1) Peripheral vascular disease (PVD) - Arterial disease that is untreated
•2) Evidence of gangrene of any part of the affected limb
•3) Documented evidence of osteomyelitis on any part of affected limb
•4) Index ulcer has exposed bone
•5) Index ulcer exhibits signs of severe clinical infection that requires hospitalization or immediate surgical intervention
•6) Active Charcot foot on the study limb
•7) Uncontrolled diabetes: HbA1c > 10 %
•8) Renal dialysis or creatinineine > 2.0
•9) Active treatment of malignancy (not specific to study limb) and patients on immunosuppresants
•10) Patient has a Deep Vein Thrombosis within the last 30 days
•11) Subject has received heat or oxygen therapy for the index wound

发起方

Yostra Labs Private Limited