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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05186519
Enrollment
300
Registered
2022-01-11
Start date
2015-01-01
Completion date
2021-10-15
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

Keywords

Diabetic Foot, Amputation, Cohort Study, Predict model

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.

Interventions

None listed

Sponsors

Qianfoshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
All non-traumatic amputate eventsthrough study completion, an average of 2.2 yearThe 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

MeasureTime frameDescription
Composite outcomes of serious adversethrough study completion, an average of 2.2 yearIncluding amputations, deaths and other adverse outcomes
All-cause mortalitythrough study completion, an average of 2.2 yearAll-cause mortality during hospitalization in patients with diabetic foot.
Length of stay in hospitalthrough study completion, an average of 2.2 yearHospital length of stay for diabetic foot treatment.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026