Amputation Associated Factors and Prediction Model in Diabetic Foot Patients

Study Overview
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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.

Official Title
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Amputation Associated Factors and Prediction Model in Diabetic Foot Patients : A Retrospective Cohort Study

Conditions
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Diabetic Foot

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All non-traumatic amputate events | The main outcome was any non-traumatic amputation events among patients with diabetic foots including removing all of a limb or extremity (major amputation) or a portion of a limb or extremity (minor amputation). | through study completion, an average of 2.2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcomes of serious adverse | Including amputations, deaths and other adverse outcomes | through study completion, an average of 2.2 year | 
| All-cause mortality | All-cause mortality during hospitalization in patients with diabetic foot. | through study completion, an average of 2.2 year | 
| Length of stay in hospital | Hospital length of stay for diabetic foot treatment. | through study completion, an average of 2.2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot, Amputation, Cohort Study, Predict model