Clinical trial NCT05186519: Amputation Associated Factors and Prediction Model in Diabetic Foot Patients
Official title: Amputation Associated Factors and Prediction Model in Diabetic Foot Patients : A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Keywords: Diabetic Foot
Amputation
Cohort Study
Predict model
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetic foot who were hospitalized in The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital between January 1, 2015 and October 15, 2021.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: All non-traumatic amputate events
timeFrame: through study completion, an average of 2.2 year
Secondary outcomes:
measure: Composite outcomes of serious adverse
timeFrame: through study completion, an average of 2.2 year
measure: All-cause mortality
timeFrame: through study completion, an average of 2.2 year
measure: Length of stay in hospital
timeFrame: through study completion, an average of 2.2 year
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
name: Wang Yibing, Doctor
role: PRINCIPAL_INVESTIGATOR
References: