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Does performing amputation of lower limb due to gangrene in critically ill patients in two stages allow improved results of treatment compared to single-stage amputation?

Two-phase versus one-stage amputation of lower limbs among critically ill patients with ischemic gangrene as a way to reduce lethality and improve treatment outcome. Retrospective cohort trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12604387
Enrollment
300
Registered
2020-07-07
Start date
2011-01-01
Completion date
Unknown
Last updated
2021-03-30

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

Conditions

Ischaemic gangrene of lower limb Circulatory System

Interventions

Retrospective comparison of two approaches to the treatment of critically ill patients who admit to the hospital due to ischaemic gangrene of lower limb. In 2011- 2014 (control group)

Sponsors

Sechenov University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Need to perform urgent (within 72 hours after admission to the hospital) high amputation of the lower extremities in patients with critical limb ischemia who were admitted in a severe or extremely severe condition. The indication for amputation was gangrene accompanied by a progressive infection of soft tissues or a syndrome of endogenous intoxication caused by ischemic damage to the muscle tissue of the limb.

Exclusion criteria

Exclusion criteria: 1. Patients with surgical soft tissue infection but without occlusion of the main arteries (including patients with extensive limb phlegmons with a neuropathic form of diabetic foot syndrome) 2. Patients with planned indications for amputation (including those operated within 72 hours after admission), e.g., patients with critical ischemia and gangrene of the limb if angiosurgical intervention is impossible or unsuccessful 3. Patients in whom the indications for urgent amputation of the limbs occurred during their stay in the hospital

Design outcomes

Primary

MeasureTime frame
Lethality of procedure measured using patient records at a single time point

Secondary

MeasureTime frame
Measured using patient records at a single time point: 1. Number of wound complications 2. Levels of amputation

Countries

Russian Federation

Outcome results

None listed

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