Influence of Diabetes on Lower Limb Amputation

Study Overview
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Brief Summary
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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
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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. Primary Endpoint Comparison of rehabilitation and functional outcomes in those with diabetes to those without diabetes, up to 18 months post LEA. Secondary endpoints At discharge from rehabilitation, the characteristics of those who proceed to limb fitting following LEA to those who do not will be defined. At discharge from rehabilitation, the characteristics of those with diabetes that do not proceed to limb fitting following LEA compared to those who do. At discharge from rehabilitation to 18 months post LEA, a comparison of the characteristics in those with and without diabetes. 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.

Official Title
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Rehabilitation & Function Following Lower Limb Amputation: the Influence of Diabetes

Conditions
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Diabetes, PAD

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age with a major amputation above the ankle. Exclusion Criteria: Amputation for tumour, trauma, congenital abnormalities Amputation at hip disarticulation or trans-pelvectomy level Adults with incapacity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D-5L | Quality of life measure | 3 years | 
| Reintegration to normal living index |  | 3 years | 
| Prosthetic Limb User Mobility | As assessed by the prosthetic limb user survey mobility scale | 3 years | 
| Co-morbidities | Functional co-morbidity index | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputation