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The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients

Sun Yat-sen University logo

Sun Yat-sen University

Status

Completed

Conditions

Diabetic Foot
Valve Heart Disease
Amputation
Valve Disease, Aortic

Treatments

Other: calcified cardiac valve

Study type

Observational

Funder types

Other

Identifiers

NCT06079008
SYSKY-2022-035-01

Details and patient eligibility

About

The goal of this observational study is to learn about the association between cardiac valve calcification and the 1-year mortality after lower-extremity amputation in diabetic patients. Diabetic patients requiring lower-extremity amputation were retrospectively studied. Preoperative detailed anamnesis was taken. Cardiac valve calcification was assessed using echocardiography at baseline. One-year follow-up was conducted and included clinical visits, hospital record assessment, and telephone reviews to obtain the survival status of patients. Researchers compare the survival group to the mortality group to study the relationship between the cardiac valve calcification and mortality.

Full description

This study aimed to investigate the association between cardiac valve calcification and 1-year mortality in diabetic patients after lower-extremity amputation. The investigator recruited consecutive patients who were admitted to the Sun Yat-sen Memorial Hospital for diabetic foot ulcers that needed amputation surgery. Clinical characteristics of each patient and the laboratory examination were collected before surgery. Cardiac valve calcification was assessed at baseline. This study obtained the survival status of patients within one year through outpatient follow-up and telephone follow-up. Researchers compared the survival group to the mortality group to see if the mortality group had a higher prevalence of heart valve calcification.

Enrollment

96 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Had echocardiography at baseline
  • With diabetic foot ulcers that required amputation after orthopedist's assessment

Exclusion criteria

  • Fractures due to traumatic reasons that required extremity amputation
  • Amputation level below the ankle
  • Severe sepsis that required vasoactive agent treatment
  • Rheumatic heart disease
  • Heart valve surgery history

Trial design

96 participants in 2 patient groups

survival group
Description:
The patients who survived more than 1-year after amputation surgery.
Treatment:
Other: calcified cardiac valve
mortality group
Description:
The patients who were dead within 1-year after amputation surgery.
Treatment:
Other: calcified cardiac valve

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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