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

Completed

• Conditions: Valve Disease, Aortic; Diabetic Foot; Valve Heart Disease; Amputation
• Interventions: Other: calcified cardiac valve

• Registration Number: NCT06079008
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2023-01
• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Study First Posted: 2023-10-12
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The proportion of cardiac valve calcification between survival group and mortality group	2017-12-1	The prevalence of calcified heart valve diseases was compared between the mortality group and survival group.