Amputation Associated Factors and Prediction Model in Diabetic Foot Patients

NCT05186519 | Completed

• 1 other identifier: CT2021-10-22
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

Diabetic Foot; Amputation; Cohort Study; Predict model

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Composite outcomes of serious adverse

  through study completion, an average of 2.2 year

• All-cause mortality

  through study completion, an average of 2.2 year

• Length of stay in hospital

  through study completion, an average of 2.2 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Clinical diagnosis of diabetic foot
• Hospitalized patients
• No history of amputation

You may not qualify if:

• 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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Wang Yibing, Doctor

  The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 11, 2022
• Study Start: January 1, 2015
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

CN (1)