NCT00907712

Brief Summary

Vascular lower limb amputees have an increased morbidity and mortality. The aim of the study is to evaluate the hemodynamic changes after amputation and its relation to outcome.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

1.1 years

First QC Date

May 18, 2009

Last Update Submit

June 21, 2015

Conditions

Diagnostic Techniques, Cardiovascular

Keywords

amputationvascularbelow kneeabove kneecardiovascularechocardiovascular assessment

Outcome Measures

Primary Outcomes (1)

  • cardiovascular assessment

    week

Secondary Outcomes (1)

  • complications

    month

Study Arms (1)

cardiovascular

NO INTERVENTION

cardiac echo

Other: cardiac echo examination

Interventions

cardiac echo examinationOTHER

cardiac echo examination - before and after the surgery

cardiovascular

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all vascular or diabetic patients before leg amputation

You may not qualify if:

  • traumatic amputation
  • sepsis patient
  • urgent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haemek Medical Center

Afula, Israel

Location

Related Publications (4)

  • Izumi Y, Satterfield K, Lee S, Harkless LB. Risk of reamputation in diabetic patients stratified by limb and level of amputation: a 10-year observation. Diabetes Care. 2006 Mar;29(3):566-70. doi: 10.2337/diacare.29.03.06.dc05-1992.

    PMID: 16505507BACKGROUND

  • Izumi Y, Satterfield K, Lee S, Harkless LB, Lavery LA. Mortality of first-time amputees in diabetics: a 10-year observation. Diabetes Res Clin Pract. 2009 Jan;83(1):126-31. doi: 10.1016/j.diabres.2008.09.005. Epub 2008 Dec 20.

    PMID: 19097667BACKGROUND

  • Remes L, Isoaho R, Vahlberg T, Hiekkanen H, Korhonen K, Viitanen M, Rautava P. Major lower extremity amputation in elderly patients with peripheral arterial disease: incidence and survival rates. Aging Clin Exp Res. 2008 Oct;20(5):385-93. doi: 10.1007/BF03325142.

    PMID: 19039278BACKGROUND

  • Papazafiropoulou A, Tentolouris N, Soldatos RP, Liapis CD, Dounis E, Kostakis AG, Bastounis E, Katsilambros N. Mortality in diabetic and nondiabetic patients after amputations performed from 1996 to 2005 in a tertiary hospital population: a 3-year follow-up study. J Diabetes Complications. 2009 Jan-Feb;23(1):7-11. doi: 10.1016/j.jdiacomp.2007.11.008. Epub 2008 Apr 16.

    PMID: 18413176BACKGROUND
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 22, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

IL(1)