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Influence of Diabetes on Lower Limb Amputation

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ClinicalTrials.gov Identifier: NCT02500303
Recruitment Status : Unknown
Verified January 2018 by Fiona Smith, University of Glasgow.
Recruitment status was:  Active, not recruiting
First Posted : July 16, 2015
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
NHS Greater Glasgow and Clyde Board HQ
Information provided by (Responsible Party):
Fiona Smith, University of Glasgow

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.

Condition or disease
Diabetes PAD

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.

  • 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 171 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Rehabilitation & Function Following Lower Limb Amputation: the Influence of Diabetes
Actual Study Start Date : March 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018



Primary Outcome Measures :
  1. Mortality [ Time Frame: 3 years ]
    Date of Death if applicable

  2. Limb fitting [ Time Frame: 3 years ]
    Dtae of receiving prosthetic limb

  3. Length of stay [ Time Frame: 3 years ]
    Length of time in hospital as an in patient

  4. Readmission [ Time Frame: 3 years ]
    Date of readmission to hospital

  5. Further surgery [ Time Frame: 3 years ]
    Number and level of further amputations


Secondary Outcome Measures :
  1. EQ-5D-5L [ Time Frame: 3 years ]
    Quality of life measure

  2. Reintegration to normal living index [ Time Frame: 3 years ]
  3. Prosthetic Limb User Mobility [ Time Frame: 3 years ]
    As assessed by the prosthetic limb user survey mobility scale

  4. Co-morbidities [ Time Frame: 3 years ]
    Functional co-morbidity index



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All persons over 18 years old undergoing a lower limb amputation for Diabetes and / or peripheral arterial disease within the Greater Glasgow & Clyde area.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500303


Locations
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United Kingdom
Western Infirmary
Glasgow, United Kingdom, G11 6NT
Sponsors and Collaborators
University of Glasgow
NHS Greater Glasgow and Clyde Board HQ
Investigators
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Study Director: Lorna Paul, PhD University of Glasgow
Additional Information:

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Responsible Party: Fiona Smith, PhD Student & Chief Investigator, University of Glasgow
ClinicalTrials.gov Identifier: NCT02500303    
Other Study ID Numbers: GN13DI563
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Keywords provided by Fiona Smith, University of Glasgow:
Amputation
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases