Clinical Trials Directory

Trials / Completed

CompletedNCT05186519

Amputation Associated Factors and Prediction Model in Diabetic Foot Patients

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

Status
Completed
Phase
Study type
Observational
Enrollment
300 (actual)
Sponsor
Qianfoshan Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2015-01-01
Primary completion
2021-10-15
Completion
2021-10-15
First posted
2022-01-11
Last updated
2022-01-11

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05186519. Inclusion in this directory is not an endorsement.