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

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.

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Key information

Conditions

Amputation Aortic Valve Disease Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Heart Diseases Heart Valve Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Valve Disease, Aortic Valve Heart Disease Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

calcified cardiac valve

Other

patients have cardiac cardiac valve before surgery

Primary outcomes

The proportion of cardiac valve calcification between survival group and mortality group

Time frame: 2017-12-1

The prevalence of calcified heart valve diseases was compared between the mortality group and survival group.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2022
Study completion: 2022
First posted: Oct 12, 2023
Registry last updated: Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed