Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
171 participants
OBSERVATIONAL
2014-03-31
2018-12-31
Brief Summary
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Detailed Description
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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
1. At discharge from rehabilitation, the characteristics of those who proceed to limb fitting following LEA to those who do not will be defined.
2. At discharge from rehabilitation, the characteristics of those with diabetes that do not proceed to limb fitting following LEA compared to those who do.
3. At discharge from rehabilitation to 18 months post LEA, a comparison of the characteristics in those with and without diabetes.
4. 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Amputation at hip disarticulation or trans-pelvectomy level
* Adults with incapacity
18 Years
ALL
No
Sponsors
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NHS Greater Glasgow and Clyde Board HQ
OTHER
University of Glasgow
OTHER
Responsible Party
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Fiona Smith
PhD Student & Chief Investigator
Principal Investigators
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Lorna Paul, PhD
Role: STUDY_DIRECTOR
University of Glasgow
Locations
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Western Infirmary
Glasgow, , United Kingdom
Countries
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Other Identifiers
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GN13DI563
Identifier Type: -
Identifier Source: org_study_id
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