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WithdrawnNCT00907712Updated Jun 23, 2015

Cardiovascular Assessment Before and After Limb Amputation

An interventional study of cardiac echo examination in Diagnostic Techniques, Cardiovascular, sponsored by HaEmek Medical Center, Israel. Withdrawn at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-23.

Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
Department difficulties
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diagnostic Techniques, Cardiovascular

Keywords

  • amputation
  • vascular
  • below knee
  • above knee
  • cardiovascular
  • echo
  • cardiovascular assessment
03

In context

Lead sponsor

HaEmek Medical Center, Israel is the lead sponsor of 228 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • all vascular or diabetic patients before leg amputation

Exclusion criteria

Exclusion Criteria:

  • traumatic amputation
  • sepsis patient
  • urgent surgery
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • No intervention
    cardiovascular

    cardiac echo

    Other: cardiac echo examination

Interventions

  • Othercardiac echo examination

    cardiac echo examination - before and after the surgery

06

What researchers measure

Primary outcomes

  1. cardiovascular assessment

    Time frame: week

Secondary outcomes

  1. complications

    Time frame: month

07

Study locations

1 site
  • Haemek Medical Center
    Afula, Israel
08

References and documents

Publications

  • 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. PubMed 16505507 ↗
  • 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. PubMed 19097667 ↗
  • 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. PubMed 19039278 ↗
  • 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. PubMed 18413176 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00907712
Lead sponsor
HaEmek Medical Center, Israel
First posted
May 22, 2009
Start date
May 2009
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Jun 23, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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