DiabetesNCT02500303
Influence of Diabetes on Lower Limb Amputation
An observational study of Diabetes and PAD, run by University of Glasgow at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 171 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Dec 2018
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Over 18 years of age with a major amputation above the ankle.
Who cannot join
- Amputation for tumour, trauma, congenital abnormalities
- Amputation at hip disarticulation or trans-pelvectomy level
- Adults with incapacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation & Function Following Lower Limb Amputation: the Influence of Diabetes
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.
Read the 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
- At discharge from rehabilitation, the characteristics of those who proceed to limb fitting following LEA to those who do not will be defined.
- At discharge from rehabilitation, the characteristics of those with diabetes that do not proceed to limb fitting following LEA compared to those who do.
- At discharge from rehabilitation to 18 months post LEA, a comparison of the characteristics in those with and without diabetes.
- 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.
- Keywords
- Amputation
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Date of Death if applicable
Measured: 3 years
Limb fitting
Dtae of receiving prosthetic limb
Measured: 3 years
Length of stay
Length of time in hospital as an in patient
Measured: 3 years
Readmission
Date of readmission to hospital
Measured: 3 years
Further surgery
Number and level of further amputations
Measured: 3 years
Secondary outcomes (4)
EQ-5D-5L
Quality of life measure
Measured: 3 years
Reintegration to normal living index
Measured: 3 years
Prosthetic Limb User Mobility
As assessed by the prosthetic limb user survey mobility scale
Measured: 3 years
Co-morbidities
Functional co-morbidity index
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startMar 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde Board HQ
- Responsible party
- Principal investigator, Fiona Smith, University of Glasgow
- Investigators
- Lorna Paul, PhD, Study director, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500303
- Sponsor's protocol ID
- GN13DI563
- Status last verified
- Jan 2018
- First submitted
- 2 Dec 2014
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation & Function Following Lower Limb Amputation: the Influence of Diabetes
- ClinicalTrials.gov ID
- NCT02500303
- Acronym / sponsor ID
- GN13DI563
- Keywords
- Amputation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde Board HQ
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- At discharge from rehabilitation, the characteristics of those who proceed to limb fitting following LEA to those who do not will be defined.
- At discharge from rehabilitation, the characteristics of those with diabetes that do not proceed to limb fitting following LEA compared to those who do.
- At discharge from rehabilitation to 18 months post LEA, a comparison of the characteristics in those with and without diabetes.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Over 18 years of age with a major amputation above the ankle.
Key exclusion criteria (3 listed)
- Amputation for tumour, trauma, congenital abnormalities
- Amputation at hip disarticulation or trans-pelvectomy level
- Adults with incapacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 3 years
Date of Death if applicable
Limb fitting
Time frame: 3 years
Dtae of receiving prosthetic limb
Length of stay
Time frame: 3 years
Length of time in hospital as an in patient
Readmission
Time frame: 3 years
Date of readmission to hospital
Further surgery
Time frame: 3 years
Number and level of further amputations
4 secondary outcomes
EQ-5D-5L
Time frame: 3 years
Reintegration to normal living index
Time frame: 3 years
Prosthetic Limb User Mobility
Time frame: 3 years
Co-morbidities
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna Paul, PhD study director
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and PAD, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.