NCT05123157

Brief Summary

This study explored the pattern and type of amputations performed on patients with diabetic foot who were admitted to our institution, as well as the 7-year mortality rate of patients with diabetic foot at the same institution. We believe that our study makes a significant contribution to the literature because it highlights the need for strengthening efforts to decrease the risk of amputation and mortality among patients with diabetic foot, especially in Jeddah, Saudi Arabia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
358

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 20, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

October 20, 2021

Last Update Submit

November 5, 2021

Conditions

Diabetic FootAmputation

Outcome Measures

Primary Outcomes (2)

  • Rate and Pattern of amputation.

    identify how many patients with Diabetic foot underwent amputation, and what type of amputation (major or minor)

    7 years

  • Mortality among patients with diabetic foot

    7-years mortality rate and predictive variable of death among patients with Diabetic foot.

    7 years

Interventions

NO interventionOTHER

N/: NO intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

medical records of King Abdulaziz University Hospital (KAUH).

You may qualify if:

  • From the medical records of King Abdulaziz University Hospital (KAUH).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Jeddah, Mecca Region, 80502, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 17, 2021

Study Start

September 1, 2020

Primary Completion

October 15, 2021

Study Completion

October 19, 2021

Last Updated

November 17, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)