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NCT06079008 Clinical Trial

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

Diabetic Foot Clinical Trial

Official title:
The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients: a Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06079008
Other study ID # SYSKY-2022-035-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2016
Est. completion date June 1, 2022

Study information
Verified date January 2023
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• calcified cardiac valve
patients have cardiac cardiac valve before surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of cardiac valve calcification between survival group and mortality group The prevalence of calcified heart valve diseases was compared between the mortality group and survival group. 2017-12-1
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