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

Yibing Wang

Status: Completed

Conditions: Diabetic Foot

Study type: Observational

Funder types: Other

Identifiers

NCT05519163

YXLL-KY-2022(063)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,301 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

6,301 participants in 1 patient group

Patients with type 2 diabetes

Description:

Patients with type 2 diabetes who were hospitalized in The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital between January 1, 2016 and December 31, 2021.