Vascular Disease, PeripheralVAmPP-QNCT05860764
Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study
An observational study of Vascular Disease, Peripheral and Amputation, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Background: Peripheral arterial disease (PAD) is the main cause of amputation to the lower limb within the UK, affecting over 20% of adults older than 70 years. After an amputation, individuals often use a wheelchair and do not walk with a prosthetic limb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Disease, Peripheral, Amputation, Physical Disability
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2023to Sep 2024
- 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: 2 groups of participants in one cohort * participants who have undergone an amputation due to peripheral arterial disease, 'vascular amputees' * healthcare professionals that work with vascular amputees in clinical practice
Who may be able to join
- Undergone major lower limb amputation due to peripheral arterial disease and/or diabetes at any time point
- or
- Planned date for major lower limb amputation within 1 week of consent due to peripheral arterial disease and/or diabetes
- Healthcare professional currently working with vascular amputees. Healthcare professional defined as qualified professional background e.g. HCPC, NMC or GMC registered or non-qualified professional background e.g. healthcare support worker
Who cannot join
- Has/will undergo a minor amputation only
- Amputation due to alternative aetiology
- No plan for amputation to lower limb
- Unable to communicate or write in English
- Lacking capacity to consent to research study
- >1 weeks or unspecified date for amputation surgery
Show all 10Show fewer
- <18 years
- Healthcare professional group:
- No experience of working with vascular amputee patients
- Unable to speak or write English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Department of Cardiovascular Sciences, University of Leicester
Leicester
Miss Essop-Adam, +44 (0)116 258 3473, aea19@leicester.ac.uk
Miss Payne, +44 (0)116 258 3473, tjp28@leicester.ac.uk
About this study
Official title: Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study: Exploratory Study Investigating Perceptions and Experience of Physical Performance and Physical Assessment of Vascular Amputees Using Performance Based Outcome Measures
Background:
Peripheral arterial disease (PAD) is the main cause of amputation to the lower limb within the UK, affecting over 20% of adults older than 70 years.
Read more
After an amputation, individuals often use a wheelchair and do not walk with a prosthetic limb. This is due to them experiencing: older age, muscle weakness, pain, other health conditions limiting ability to exercise eg. heart problems.
Healthcare professionals assess physical function with Physical Performance Based Outcome Measures (PerBOMs). A PerBOM requires an individual to complete tasks that are part of their day to day life e.g. walking or balance.
PerBOMs are used with for:
- Setting goals with patients
- Assessing how patients respond to treatment/rehabilitation
- Predicting if patients are likely to use a prosthetic limb in the future
Previous research shows most of the available PerBOMs are suitable an amputee who walks with a prosthetic limb. However, most vascular amputee patients cannot benefit from these assessments.
Therefore, based on this evidence we have developed a new PerBOM to help manage vascular amputees who do not walk with a prosthetic limb.
Methods:
Qualitative interviews and focus groups with amputee individuals and healthcare professionals who treat them. Approaching individuals who have or will undergo an amputation to their leg due to PAD. Approaching healthcare professionals through professional networks.
Interviews and focus groups will take place face to face or remotely by telephone/video conferencing, lasting approximately 1-2 hrs.
In the interview or focus group, the researcher will explain and show individuals a video of the new PerBOM and explore their opinions qualitatively on this new PerBOM.
All audio will be recorded, written up and analysed. All findings will be presented at scientific conferences.
This study has been developed with patients and public involvement.
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| vascular amputees and healthcare professionals | participants who have undergone an amputation due to peripheral arterial disease and healthcare professionals who treat these participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
qualitative theme identification
qualitative themes will be identified after data collection through qualitative interviews and focus groups and thematic analysis has taken place
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Feb 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Disease, PeripheralStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860764
- Sponsor's protocol ID
- 0873
- Acronym
- VAmPP-Q
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study: Exploratory Study Investigating Perceptions and Experience of Physical Performance and Physical Assessment of Vascular Amputees Using Performance Based Outcome Measures
- ClinicalTrials.gov ID
- NCT05860764
- Acronym / sponsor ID
- VAmPP-Q / 0873
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 16 May 2023 (actual)
- 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.
Background:
Peripheral arterial disease (PAD) is the main cause of amputation to the lower limb within the UK, affecting over 20% of adults older than 70 years.
After an amputation, individuals often use a wheelchair and do not walk with a prosthetic limb. This is due to them experiencing: older age, muscle weakness, pain, other health conditions limiting ability to exercise eg. heart problems.
Healthcare professionals assess physical function with Physical Performance Based Outcome Measures (PerBOMs). A PerBOM requires an individual to complete tasks that are part of their day to day life e.g. walking or balance.
PerBOMs are used with for:
- Setting goals with patients
- Assessing how patients respond to treatment/rehabilitation
- Predicting if patients are likely to use a prosthetic limb in the future
Previous research shows most of the available PerBOMs are suitable an amputee who walks with a prosthetic limb. However, most vascular amputee patients cannot benefit from these assessments.
Therefore, based on this evidence we have developed a new PerBOM to help manage vascular amputees who do not walk with a prosthetic limb.
Methods:
Qualitative interviews and focus groups with amputee individuals and healthcare professionals who treat them. Approaching individuals who have or will undergo an amputation to their leg due to PAD. Approaching healthcare professionals through professional networks.
Interviews and focus groups will take place face to face or remotely by telephone/video conferencing, lasting approximately 1-2 hrs.
In the interview or focus group, the researcher will explain and show individuals a video of the new PerBOM and explore their opinions qualitatively on this new PerBOM.
All audio will be recorded, written up and analysed. All findings will be presented at scientific conferences.
This study has been developed with patients and public involvement.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vascular amputees and healthcare professionals | – | –participants who have undergone an amputation due to peripheral arterial disease and healthcare professionals who treat these participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2 groups of participants in one cohort * participants who have undergone an amputation due to peripheral arterial disease, 'vascular amputees' * healthcare professionals that work with vascular amputees in clinical practice
Key inclusion criteria (4 listed)
- Undergone major lower limb amputation due to peripheral arterial disease and/or diabetes at any time point
- or
- Planned date for major lower limb amputation within 1 week of consent due to peripheral arterial disease and/or diabetes
- Healthcare professional currently working with vascular amputees. Healthcare professional defined as qualified professional background e.g. HCPC, NMC or GMC registered or non-qualified professional background e.g. healthcare support worker
Key exclusion criteria (10 listed)
- Has/will undergo a minor amputation only
- Amputation due to alternative aetiology
- No plan for amputation to lower limb
- Unable to communicate or write in English
- Lacking capacity to consent to research study
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
qualitative theme identification
Time frame: baseline
qualitative themes will be identified after data collection through qualitative interviews and focus groups and thematic analysis has taken place
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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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.
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 Vascular Disease, Peripheral and Amputation, run by University of Leicester 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 4 inclusion and 10 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 16 May 2023. 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?
Contact Miss Essop-Adam (+44 (0)116 258 3473, aea19@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
qualitative theme identification (time frame: baseline). 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 16 May 2023.