Amputation Associated Factors and Prediction Model in Diabetic Foot Patients

NCT ID: NCT05186519

Last Updated: 2022-01-11

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

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2021-10-15

Brief Summary

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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.

The aim of this study is to assess factors associated with the occurrence of amputation events in the diabetic foot patients based on a retrospective cohort and to construct a prediction model for patients at high amputated risk.

Detailed Description

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Diabetic foot is one of the major complications observed in patients with diabetes. Diabetic foot can lead to non-traumatic lower-limb amputation (LLA), and is confirmed to be associated with cognitive decline and worsening quality of life. Previous studies indicated that diabetics had a 25% lifetime risk of developing diabetic foot, and 14% to 24% of those require amputation. In patients with poor results of conservative treatment, amputation is the main terminal treatment option to avoid the spread of infection.

Amputation in diabetic foot patients may linked to different causes, including inflammatory, infectious and malignant conditions. A retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform is conducted to evaluate the progression and prognosis of diabetic foot patients. A prediction model will be developed to identify high-risk diabetic foot patients of amputation and provide a scientific basis for personalized clinical care.

Conditions

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Diabetic Foot

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of diabetic foot
* Hospitalized patients
* No history of amputation

Exclusion Criteria

* Patients with Bone Neoplasms
* Patients with osteomyelitis not caused by diabetes
* Patients with amputation caused by severe peripheral vascular disease not caused by diabetes
* Traumatic Amputations
* Patients in shock on admission
* Patients discharged against medical advice
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Other Identifiers

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CT2021-10-22

Identifier Type: -

Identifier Source: org_study_id

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