Amputation Associated Factors and Prediction Model in Diabetic Foot Patients

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05186519
• Other study ID #: CT2021-10-22
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: October 15, 2021

Study information

• Verified date: December 2021
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

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