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

NCT05519163 | Completed

• 1 other identifier: YXLL-KY-2022(063)
• Study Type: observational
• Target: 6,301
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

Diabetes Mellitus, Type 2; Diabetic Foot; Predictive model; cohort study

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with type 2 diabetes

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Clinical diagnosis of type 2 diabetes
• Hospitalized patients
• The interval between two records is more than one year

You may not qualify if:

• Any history of ulcer or amputation previously
• The patients with type 1 diabetes
• Pregnant during the study
• Patients with malignant tumors
• Complicated with serious organ dysfunction, such as heart, liver and kidney

Sponsors & Collaborators

• Yibing Wang: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

Location

Related Publications (1)

• Li MZ, Tang F, Liu YF, Lao JH, Yang Y, Cao J, Song R, Wu P, Wang YB. Risk factors and a predictive model of diabetic foot in hospitalized patients with type 2 diabetes. World J Diabetes. 2025 Mar 15;16(3):95644. doi: 10.4239/wjd.v16.i3.95644.

  PMID: 40093275 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus, Type 2

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; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Wang Yibing, Doctor

  The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 29, 2022
• Study Start: January 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

CN (1)