Effectiveness and safety of blood thinning agent (Anticoagulation) in patients with dying limb with poor blood supply (Digital Gangrene) and an underlying immune system related disease (Connective Tissue Disease)
Phase 3
- Conditions
- Health Condition 1: M339- Dermatopolymyositis, unspecifiedHealth Condition 2: M319- Necrotizing vasculopathy, unspecifiedHealth Condition 3: M340- Progressive systemic sclerosisHealth Condition 4: M368- Systemic disorders of connective tissue in other diseases classified elsewhereHealth Condition 5: M359- Systemic involvement of connectivetissue, unspecifiedHealth Condition 6: M321- Systemic lupus erythematosus withorgan or system involvement
- Registration Number
- CTRI/2024/03/063481
- Lead Sponsor
- Department of Clinical Immunology & Rheumatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients with digital gangrene of duration less than or equal to 1 month, defined as bluish blackish
discoloration of any digit, including pre-gangrenous changes in the form of intense pain, pallor
and/or dusky colour change of digits and delayed capillary refill time.
2. Patients with a diagnosis of Connective tissue disorder (CTD) as per latest standard
diagnostic/classification criteria
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause outcome of digits in the form of recovery of digital gangrene at 24 weeksTimepoint: 2, 6, 12, 24 weeks
- Secondary Outcome Measures
Name Time Method Adverse eventsTimepoint: 2, 6, 12, 24 weeks;All-cause outcome of digits in the form of recovery of digital gangrene at 2 weeksTimepoint: 2 weeks;Amputation-free survival at 24 weeksTimepoint: 24 weeks;Cause-specific mortality rate at 24 weeksTimepoint: 24 weeks;Functional outcome at 24 weeks in the form of change in Lower Extremity Functional Scale (LEFS) <br/ ><br>and/or Upper Extremity Functional Index (UEFI-15) for digital gangrene involving digits of upper <br/ ><br>limbs and/or lower limbs respectivelyTimepoint: 24 weeks;Incidence of surgical/auto-amputationTimepoint: 24 weeks;To characterize clinical and serological profileTimepoint: baseline