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
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 |
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
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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