Clinical trial NCT02500303: Influence of Diabetes on Lower Limb Amputation
Official title: Rehabilitation & Function Following Lower Limb Amputation: the Influence of Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
PAD
Keywords: Amputation
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: NHS Greater Glasgow and Clyde Board HQ
First posted: 2015-07-16
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Mortality
timeFrame: 3 years
measure: Limb fitting
timeFrame: 3 years
measure: Length of stay
timeFrame: 3 years
measure: Readmission
timeFrame: 3 years
measure: Further surgery
timeFrame: 3 years
Secondary outcomes:
measure: EQ-5D-5L
timeFrame: 3 years
measure: Reintegration to normal living index
timeFrame: 3 years
measure: Prosthetic Limb User Mobility
timeFrame: 3 years
measure: Co-morbidities
timeFrame: 3 years
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Western Infirmary
Study officials:
affiliation: University of Glasgow
name: Lorna Paul, PhD
role: STUDY_DIRECTOR
References: