Amputation Associated Factors and Prediction Model in Diabetic Foot Patients

Completed

• Conditions: Diabetic Foot

• Registration Number: NCT05186519
• Lead Sponsor: Qianfoshan Hospital

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-15
• Status Verified: 2021-12
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-23
• Last Update Submitted: 2021-12-23
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All non-traumatic amputate events	through study completion, an average of 2.2 year	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China