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NCT05519163 Clinical Trial

A Study on Predictive Model for New-onset Diabetic Foot in Type 2 Diabetes Patients.

Diabetic Foot Clinical Trial

Official title:
A Study on Predictive Model for New-onset Diabetic Foot in Type 2 Diabetes Patients: A Retrospective Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05519163
Other study ID # YXLL-KY-2022(063)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2021

Study information
Verified date April 2024
Source Qianfoshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective cohort study was constructed based on hospitalized patients with type 2 diabetes, aiming to explore the related factors for new-onset diabetic foot and conducted a robust prediction model by Cox proportional hazards model.

Description:

Diabetic foot is an infection of lower extremity, ulceration and/or deep tissue damage due to neuropathy and varying degrees of vascular disease in diabetic patients, including diabetic foot ulcerations or infections. Diabetic foot can lead to adverse consequences such as amputation and death,which seriously endangering the physical and mental health and quality of life for patients. Early identification of risk factors for diabetes foot is useful to reduce the risk of hospitalization, amputation or even mortality. Most prediction models for diabetic foot focus on recurrent diabetic foot, however there is little published information on new-onset diabetic foot. This study aims to conduct a retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform and build a prediction model for the new-onset diabetic foot using the related risk factors, which is of guidance significance for clinical prevention and treatment of diabetic foot.

Recruitment information / eligibility
Status Completed
Enrollment 6301
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. Clinical diagnosis of type 2 diabetes 2. Hospitalized patients 3. The interval between two records is more than one year Exclusion Criteria: 1. Any history of ulcer or amputation previously 2. The patients with type 1 diabetes 3. Pregnant during the study 4. Patients with malignant tumors 5. Complicated with serious organ dysfunction, such as heart, liver and kidney

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Yibing Wang

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary New-onset diabetic foot Diabetic foot was defined based on the self-reported disease history and clinical diagnosis from the electronic medical records. New-onset diabetic foot was diagnosed as the first-episode during the study period. through study completion, an average of 32 months
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