Skip to main content
OpenTrials
Completed

NCT Number: NCT05186519

Amputation Associated Factors and Prediction Model in Diabetic Foot Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Jinan, Shandong, 250014, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. All non-traumatic amputate events

    Time frame: 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 outcomes

  1. Composite outcomes of serious adverse

    Time frame: through study completion, an average of 2.2 year

    Including amputations, deaths and other adverse outcomes

  2. All-cause mortality

    Time frame: through study completion, an average of 2.2 year

    All-cause mortality during hospitalization in patients with diabetic foot.

  3. Length of stay in hospital

    Time frame: through study completion, an average of 2.2 year

    Hospital length of stay for diabetic foot treatment.

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2022
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.