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

NCT ID: NCT05519163

Last Updated: 2024-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6301 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Diabetic Foot

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yibing Wang

OTHER

Sponsor Role lead

Responsible Party

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Yibing Wang

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wang Yibing, Doctor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Jinan, Shandong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40093275 (View on PubMed)

Other Identifiers

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YXLL-KY-2022(063)

Identifier Type: -

Identifier Source: org_study_id

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