Influence of Diabetes on Lower Limb Amputation

  • Clinical Studies
  • Glasgow

NIHR

clinical trial Glasgow,uk clinical research

Primary Trial ID Number

NCT02500303

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.
Research Details
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.
Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Study Type
Observational [Patient Registry]
Intervention
Sorry, this information is not available
Intervention Type
See Interventions above
Primary Outcome Measures
Mortality; 3 years; Limb fitting; 3 years; Length of stay; 3 years; Readmission; 3 years; Further surgery; 3 years
Secondary Outcome Measures
EQ-5D-5L; 3 years; Reintegration to normal living index; 3 years; Prosthetic Limb User Mobility; 3 years; Co-morbidities; 3 years
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website

Gender
Both
Age Range
18 Years – N/A
Who Can Participate
Patients
Number of Participants
170
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above

Trial Location(s)
GSK Investigational Site
Glasgow
G11 6NT
Trial Contact(s)
Primary Trial Contact
Fiona Smith, MSc
f.smith.3@research.gla.ac.uk
01413307154
Other Trial Contacts
Lorna Paul, PhD
l.paul@gla.ac.uk
0141 330 6876
Countries Recruiting
United Kingdom

Scientific Title
Rehabilitation & Function Following Lower Limb Amputation: the Influence of Diabetes
EudraCT Number
Not available for this trial
Funder(s)
NHS GG&C
Other Study ID Numbers
GN13DI563
Sponsor(s)
University of Glasgow

 

To apply for this job please visit the following URL: http://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=30251 →