CTRI/2017/02/007930
Completed
未知
STRIDE â?? Study of the effect of Topical waRm oxygen In treatment of Diabetic foot ulcEr - STRIDE
Yostra Labs Private Limited0 sites20 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yostra Labs Private Limited
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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