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| Name | Class |
|---|---|
| NHS Greater Glasgow and Clyde Board HQ | OTHER |
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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.
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
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D-5L | Quality of life measure | 3 years |
| Reintegration to normal living index | 3 years | |
| Prosthetic Limb User Mobility |
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Inclusion Criteria:
Exclusion Criteria:
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All persons over 18 years old undergoing a lower limb amputation for Diabetes and / or peripheral arterial disease within the Greater Glasgow & Clyde area.
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| Name | Affiliation | Role |
|---|---|---|
| Lorna Paul, PhD | University of Glasgow | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Infirmary | Glasgow | G11 6NT | United Kingdom |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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As assessed by the prosthetic limb user survey mobility scale |
| 3 years |
| Co-morbidities | Functional co-morbidity index | 3 years |