Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
The death of tissue as a result of deficient blood supply (ischaemic gangrene) is treated by amputation of the affected body part. This results in a large number of wound complications and death. There are two methods of amputation in common use, one-stage and two-stage.
Two-stage amputation is a well-known way to reduce wound complications in patients with a high risk of infection (e.g. contaminated trauma or infected diabetic foot), but there is still lack of evidence if it can lower the mortality in severely ill patients with a complicated background of diseases.

Who can participate?
Patients requiring urgent amputation.

What does the study involve?
Records were collected for patients who had either had amputation using intensive treatment during 24 - 72 hours before surgery, and then fulfil one-stage amputation, or immediate guillotine amputation followed by reampuation after stabilisation.

What are the possible benefits and risks of participating?
None (retrospective study)

Where is the study run from?
Vinogradov Moscow Municipal hospital (Russia)

When is the study starting and how long is it expected to run for?
December 2017 to December 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Prof. Vitaly Tsvetkov,

Trial website

Contact information



Primary contact

Prof Vitaly Tsvetkov


Contact details

Vavilova str.
Russian Federation
+7 9166312613

Additional identifiers

EudraCT number

Nil known number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

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.



Study hypothesis

Use of urgent guillotine amputation of lower limb in critically ill patients with ischaemic gangrene as the first stage of surgical treatment allows to reduce lethality, number of wound complications and improve functional result.

Ethics approval

Approved 24/02/2018, Local Ethics Committee of the V.V. Vinogradov Moscow Municipal Hospital (61, Vavilova str., Moscow, Russia; no telephone number provided;, ref: none provided

Study design

Observational cohort retrospective study in two clinical centers

Primary study design


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet

n/a (retrospective review of patient records)


Ischaemic gangrene of lower limb


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) the tactic was to perform intensive treatment during 24 - 72 hours before surgery, and then fulfil one-stage amputation with primary formation of the stump.
In 2014 - 2018 (main group) the patients underwent urgent guillotine amputation or knee disarticulation, and then, after normalisation or stabilisation of general condition, reamputation with formation of the stump was performed.
The goal of the study is to compare these surgical tactics and their influence at the lethality, number of wound complications and functional

Records are gathered for patients in two groups:
1. Two-phase amputation including urgent guillotine amputation or knee disarticulation as a first stage an then reamputation with shaping of stump after stabilisation of patient general condition.
2. Intensive treatment before surgery, then one-stage amputation.

Intervention type



Drug names

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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.

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

Russian Federation

Trial participating centre

Vinogradov Moscow Municipal hospital
61, Vavilova str.
Russian Federation

Trial participating centre

Moscow Municipal Clinical hospital 53
26, Trophimova str
Russian Federation

Sponsor information


Sechenov University

Sponsor details

Trubetskaya str.
Russian Federation
+7 (495) 609-14-00

Sponsor type




Funder type


Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Publication in peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request after the results have been published.

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/07/2020: Trial’s existence confirmed by Local Ethics Committee of the V.V. Vinogradov Moscow Municipal Hospital.