NCT03539120

Brief Summary

This is a retrospective data analysis of patients who underwent lower limb amputation and rehabilitation and follow up. Investigators analysed their survival outcomes in relation to various comorbidities i. e ischaemic heart disease, renal impairment, vascular interventions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

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

March 24, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
Last Updated

May 29, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

May 3, 2018

Last Update Submit

May 25, 2018

Conditions

Amputation

Outcome Measures

Primary Outcomes (1)

  • survival in relation to time

    Survival outcomes were analysed and have been included in the results.

    6 months to 6 years

Interventions

Follow up for survivalOTHER

No intervention, this is an observational study of survival outcomes.

Eligibility Criteria

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

This study aimed to analyse survival outcome in patients with dysvascular lower limb amputation and identify relationship with existing comorbidities, i.e. diabetes mellitus (DM), peripheral vascular disease (PVD), ischaemic heart disease (IHD), estimated glomerular filtration rate (e-GFR), and chronic kidney disease (CKD). We also analysed the length of hospital stay, linear relationship with duration of DM, and vascular interventions.

You may qualify if:

  • Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.

You may not qualify if:

  • Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 29, 2018

Study Start

March 24, 2016

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

May 29, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share