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NCT Number: NCT05519163

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

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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Jinan, Shandong, 250014, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. New-onset diabetic foot

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yibing Wang

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Aug 29, 2022
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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