Influence of Diabetes on Lower Limb Amputation
Study Details
Study Description
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.
Detailed Description
This research has been designed to ask the following question: What are the factors that influence the rehabilitation and functional outcomes following LEA, in the long term in both those with and without diabetes.
Therefore this study will be a prospective observational analysis of all those who undergo a LEA in one year within the Greater Glasgow & Clyde area with follow up at 6, 12 & 18 months from date of amputation.
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Primary Endpoint Comparison of rehabilitation and functional outcomes in those with diabetes to those without diabetes, up to 18 months post LEA.
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Secondary endpoints
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At discharge from rehabilitation, the characteristics of those who proceed to limb fitting following LEA to those who do not will be defined.
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At discharge from rehabilitation, the characteristics of those with diabetes that do not proceed to limb fitting following LEA compared to those who do.
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At discharge from rehabilitation to 18 months post LEA, a comparison of the characteristics in those with and without diabetes.
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From six months post LEA, at 6 monthly intervals (6,12 & 18 months), a comparison of the health status, social circumstances, mobility and quality of life measures in those with and without diabetes.
Study Design
Outcome Measures
Primary Outcome Measures
- Mortality [3 years]
Date of Death if applicable
- Limb fitting [3 years]
Dtae of receiving prosthetic limb
- Length of stay [3 years]
Length of time in hospital as an in patient
- Readmission [3 years]
Date of readmission to hospital
- Further surgery [3 years]
Number and level of further amputations
Secondary Outcome Measures
- EQ-5D-5L [3 years]
Quality of life measure
- Reintegration to normal living index [3 years]
- Prosthetic Limb User Mobility [3 years]
As assessed by the prosthetic limb user survey mobility scale
- Co-morbidities [3 years]
Functional co-morbidity index
Eligibility Criteria
Criteria
Inclusion Criteria:
- Over 18 years of age with a major amputation above the ankle.
Exclusion Criteria:
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Amputation for tumour, trauma, congenital abnormalities
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Amputation at hip disarticulation or trans-pelvectomy level
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Adults with incapacity
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Western Infirmary | Glasgow | United Kingdom | G11 6NT |
Sponsors and Collaborators
- University of Glasgow
- NHS Greater Glasgow and Clyde Board HQ
Investigators
- Study Director: Lorna Paul, PhD, University of Glasgow
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GN13DI563