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

Completed

• Conditions: Diabetic Foot

• Registration Number: NCT05519163
• Lead Sponsor: Yibing Wang

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6301

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
New-onset diabetic foot	through study completion, an average of 32 months	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China