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

NCT06079008 | Completed

• 1 other identifier: SYSKY-2022-035-01
• Study Type: observational
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Amputation; Diabetic Foot; Valve Disease, Aortic; Valve Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

survival group

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

Other: calcified cardiac valve

mortality group

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

Other: calcified cardiac valve

Interventions

calcified cardiac valve OTHER

patients have cardiac cardiac valve before surgery

mortality group; survival group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigator recruited consecutive patients who were admitted to the Sun Yat-sen Memorial Hospital for diabetic foot ulcers that needed amputation surgery between July 2017 and March 2021 and were followed up for 1 year after amputation surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Diabetic Foot; Aortic Valve Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Heart Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: October 12, 2023
• Study Start: June 1, 2016
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share