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

NCT ID: NCT06079008

Last Updated: 2023-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2022-06-01

Brief Summary

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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

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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.

Conditions

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Amputation Diabetic Foot Valve Disease, Aortic Valve Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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survival group

The patients who survived more than 1-year after amputation surgery.

calcified cardiac valve

Intervention Type OTHER

patients have cardiac cardiac valve before surgery

mortality group

The patients who were dead within 1-year after amputation surgery.

calcified cardiac valve

Intervention Type OTHER

patients have cardiac cardiac valve before surgery

Interventions

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calcified cardiac valve

patients have cardiac cardiac valve before surgery

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SYSKY-2022-035-01

Identifier Type: -

Identifier Source: org_study_id

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