Cardiovascular Assessment Before and After Limb Amputation

Diagnostic Techniques, Cardiovascular Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00907712
• Other study ID #: 10-09
• Status: Withdrawn
• Phase: N/A
• First received: May 18, 2009
• Last updated: June 21, 2015
• Start date: May 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all vascular or diabetic patients before leg amputation

Exclusion Criteria:

• traumatic amputation

• sepsis patient

• urgent surgery

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diagnostic Techniques, Cardiovascular

Intervention

Other:
• cardiac echo examination
cardiac echo examination - before and after the surgery

Locations

Country	Name	City	State
Israel	Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular assessment		week	No
Secondary	complications		month	No