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)

Efficacy and Safety of Anticoagulation in patients with Digital Gangrene and an underlying Connective Tissue Disease - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063481

Enrollment

Registered

2024-03-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M339- Dermatopolymyositis, unspecified Health Condition 2: M319- Necrotizing vasculopathy, unspecified Health Condition 3: M340- Progressive systemic sclerosis Health Condition 4: M368- Systemic disorders of connective tissue in other diseases classified elsewhere Health Condition 5: M359- Systemic involvement of connectivetissue, unspecified Health Condition 6: M321- Systemic lupus erythematosus withorgan or system involvement

Interventions

Intervention1: Anticoagulation (warfarin): Patients having digital gangrene and an underlying connective tissue disorder will receive anticoagulation (Heparin 333 IU subcutaneous stat followed by 250

Eligibility

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
All-cause outcome of digits in the form of recovery of digital gangrene at 24 weeksTimepoint: 2, 6, 12, 24 weeks	—

Secondary

Measure	Time frame
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) and/or Upper Extremity Functional Index (UEFI-15) for digital gangrene involving digits of upper limbs and/or lower limbs respectivelyTimepoint: 24 weeks;Incidence of surgical/auto-amputationTimepoint: 24 weeks;To characterize clinical and serological profileTimepoint: baseline	—

Measure

Time frame

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) and/or Upper Extremity Functional Index (UEFI-15) for digital gangrene involving digits of upper limbs and/or lower limbs respectivelyTimepoint: 24 weeks;Incidence of surgical/auto-amputationTimepoint: 24 weeks;To characterize clinical and serological profileTimepoint: baseline

—

Countries

India

Contacts

Public ContactRohan Goel

IPGMER

geet4in@yahoo.co.in9433514259

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026