Influence of Diabetes on Lower Limb Amputation
Rehabilitation & Function Following Lower Limb Amputation: the Influence of Diabetes
1 other identifier
observational
171
1 country
1
Brief Summary
The purpose of this study is to explore the factors that influence limb fitting in those with diabetes compared to those without diabetes. The population without diabetes will usually present with peripheral arterial disease (PAD) and are similar in management following LEA. The impact that not walking with a prosthesis has long term on both populations will be explored. In general, previous research has used retrospective analysis of case notes which, although valuable, have fixed fields and only allow the researcher to look at associations between factors not at causation. Additionally, very few have followed a population over time. Therefore this study will be a prospective observational analysis of all those who undergo a LEA in one year from 01/03/14 to 28/02/15 within the Greater Glasgow \& Clyde area with follow up at 6, 12 \& 18 months from date of amputation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJanuary 26, 2018
January 1, 2018
4.8 years
December 2, 2014
January 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Mortality
Date of Death if applicable
3 years
Limb fitting
Dtae of receiving prosthetic limb
3 years
Length of stay
Length of time in hospital as an in patient
3 years
Readmission
Date of readmission to hospital
3 years
Further surgery
Number and level of further amputations
3 years
Secondary Outcomes (4)
EQ-5D-5L
3 years
Reintegration to normal living index
3 years
Prosthetic Limb User Mobility
3 years
Co-morbidities
3 years
Eligibility Criteria
All persons over 18 years old undergoing a lower limb amputation for Diabetes and / or peripheral arterial disease within the Greater Glasgow \& Clyde area.
You may qualify if:
- Over 18 years of age with a major amputation above the ankle.
You may not qualify if:
- Amputation for tumour, trauma, congenital abnormalities
- Amputation at hip disarticulation or trans-pelvectomy level
- Adults with incapacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Glasgowlead
- NHS Greater Glasgow and Clyde Board HQcollaborator
Study Sites (1)
Western Infirmary
Glasgow, G11 6NT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lorna Paul, PhD
University of Glasgow
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student & Chief Investigator
Study Record Dates
First Submitted
December 2, 2014
First Posted
July 16, 2015
Study Start
March 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
January 26, 2018
Record last verified: 2018-01