AmputationPERCEIVENCT04903756
The PERCEIVE Study
An observational study of Amputation and Peripheral Artery Disease, run by Aneurin Bevan University Health Board at 1 site in United Kingdom.
Trial summary
The PERCEIVE (PrEdiction of Risk and Communication of outcomE followIng major lower limb amputation - a collaboratiVE study) study aims to explore how decisions about major lower limb amputations are made by patients and healthcare professionals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Peripheral Artery Disease, Diabetes Mellitus
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2020to 20 Dec 2022
- 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: Participants are eligible for the study if they meet all of the following inclusion criteria and none of the exclusion criteria apply. All queries about participant eligibility should be directed to the Qualitative Researcher. We will purposively sample participants from up to four participating NHS Health Boards / Trusts in Wales and England. We will aim to include 8-10 surgeons, 1-3 anaesthetists and 1-3 specialist physiotherapists from several Health Boards / Trusts. We will purposively sample patients for inclusion in the audio-recorded consultations and interviews to ensure our sample has variation in terms of gender, age, MLLA type (above knee/below knee/no amputation) and Health Board / Trust.
Who may be able to join
- Any patient aged 18 years old or over with chronic limb threatening ischaemia or diabetic foot disease for whom major lower limb amputation is considered or discussed
- Vascular surgeons / anaesthetists / specialist physiotherapists involved in, or supporting major lower limb amputation decision making
Who cannot join
- Patients under 18 years old
- Patients undergoing major lower limb amputation for other causes (e.g. trauma or cancer)
- Any patient/healthcare professional unable or unwilling to provide informed consent. Some patients undergoing emergency major lower limb amputation will have insufficient time to give informed consent
- Potential participants with an insufficient understanding of English or Welsh to be able to provide informed consent
- Potential participants unable to complete an interview in English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aneurin Bevan University Health Board
Newport, NP20 2UB
About this study
Official title: Prediction of Risk and Communication of Outcome Following Major Lower Limb Amputation - a Collaborative Study (PERCEIVE). A Multi-methods Study of Risk Perception, Communication and the Extent and Experiences of Shared Decision Making Around the Time of Major Lower Limb Amputation.
The PERCEIVE (PrEdiction of Risk and Communication of outcomE followIng major lower limb amputation - a collaboratiVE study) study aims to explore how decisions about major lower limb amputations are made by patients and healthcare professionals.
Read the detailed description
This study will look in detail at major lower limb amputation risk perception, communication and decision-making, both from a patient/family and a surgeon/clinician point of view. The investigators will audio-record 10-15 consultations between surgeons and patients, examining the communication and decision-making process, and conduct individual interviews with 10-15 patients and 10-15 healthcare professionals. Patients will be interviewed at two time points: firstly as soon as possible after they discuss the possibility of leg amputation with a surgeon, and secondly around six months later. The investigators will identify what is important to patients, what information they need to make an informed decision and how best to communicate that information. Interviews with surgeons, anaesthetists and specialist physiotherapists will explore how they estimate risks and outcomes of amputation surgery, and how they communicate this to patients. Finally, the investigators will combine all this information together and discuss our findings with groups of patients and healthcare professionals, to identify key areas around amputation decision-making that can be improved and how best to further examine those areas.
- Conditions
- Amputation, Peripheral Artery Disease, Diabetes Mellitus
- Keywords
- Major lower limb amputation, Risk perception, Shared decision making
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus
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 |
|---|---|---|
| Patients | Adult patients where major lower limb amputation is being considered. | |
| Healthcare professionals | Surgeons, anaesthetists, and allied health professionals involved in decision making with patients where a major lower limb amputation is being considered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of audio-recorded consultations between surgeons and patients.
Theme-oriented discourse analysis
Measured: During primary consultation
Secondary outcomes (2)
Analysis of patient interviews
Thematic analysis of interview transcripts
Measured: As soon as possible after the time of consultation and approximately 6 months following consultation
Analysis of healthcare professional interviews
Thematic analysis of interview transcripts
Measured: As soon as possible after the time of consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Oct 2020
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aneurin Bevan University Health Board
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Care Research Wales
- Responsible party
- Principal investigator, Brenig Llwyd Gwilym, Aneurin Bevan University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903756
- Sponsor's protocol ID
- AB/136
- Acronym
- PERCEIVE
- Status last verified
- Jan 2025
- First submitted
- 24 May 2021
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prout H, Waldron CA, Gwilym B, Thomas-Jones E, Milosevic S, Pallmann P, Harris D, Edwards A, Twine CP, Massey I, Burton J, Stewart P, Jones S, Cox D, Bosanquet DC, Brookes-Howell L; PERCEIVE Study group; PERCEIVE Study. Challenges in shared decision-making about major lower limb amputation: the PERCEIVE qualitative study. BMJ Open. 2026 Jan 12;16(1):e104407. doi: 10.1136/bmjopen-2025-104407.
PubMed 41526012
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Risk and Communication of Outcome Following Major Lower Limb Amputation - a Collaborative Study (PERCEIVE). A Multi-methods Study of Risk Perception, Communication and the Extent and Experiences of Shared Decision Making Around the Time of Major Lower Limb Amputation.
- ClinicalTrials.gov ID
- NCT04903756
- Acronym / sponsor ID
- PERCEIVE / AB/136
- Conditions
- Amputation, Peripheral Artery Disease, Diabetes Mellitus
- Keywords
- Major lower limb amputation, Risk perception, Shared decision making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aneurin Bevan University Health BoardUniversity, hospital or other
- Collaborators
- Health and Care Research Wales
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 27 May 2021 (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.
The PERCEIVE (PrEdiction of Risk and Communication of outcomE followIng major lower limb amputation - a collaboratiVE study) study aims to explore how decisions about major lower limb amputations are made by patients and healthcare professionals.
Detailed description
This study will look in detail at major lower limb amputation risk perception, communication and decision-making, both from a patient/family and a surgeon/clinician point of view. The investigators will audio-record 10-15 consultations between surgeons and patients, examining the communication and decision-making process, and conduct individual interviews with 10-15 patients and 10-15 healthcare professionals. Patients will be interviewed at two time points: firstly as soon as possible after they discuss the possibility of leg amputation with a surgeon, and secondly around six months later. The investigators will identify what is important to patients, what information they need to make an informed decision and how best to communicate that information. Interviews with surgeons, anaesthetists and specialist physiotherapists will explore how they estimate risks and outcomes of amputation surgery, and how they communicate this to patients. Finally, the investigators will combine all this information together and discuss our findings with groups of patients and healthcare professionals, to identify key areas around amputation decision-making that can be improved and how best to further examine those areas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Adult patients where major lower limb amputation is being considered. |
| Healthcare professionals | – | –Surgeons, anaesthetists, and allied health professionals involved in decision making with patients where a major lower limb amputation is being considered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are eligible for the study if they meet all of the following inclusion criteria and none of the exclusion criteria apply. All queries about participant eligibility should be directed to the Qualitative Researcher. We will purposively sample participants from up to four participating NHS Health Boards / Trusts in Wales and England. We will aim to include 8-10 surgeons, 1-3 anaesthetists and 1-3 specialist physiotherapists from several Health Boards / Trusts. We will purposively sample patients for inclusion in the audio-recorded consultations and interviews to ensure our sample has variation in terms of gender, age, MLLA type (above knee/below knee/no amputation) and Health Board / Trust.
Key inclusion criteria (2 listed)
- Any patient aged 18 years old or over with chronic limb threatening ischaemia or diabetic foot disease for whom major lower limb amputation is considered or discussed
- Vascular surgeons / anaesthetists / specialist physiotherapists involved in, or supporting major lower limb amputation decision making
Key exclusion criteria (5 listed)
- Patients under 18 years old
- Patients undergoing major lower limb amputation for other causes (e.g. trauma or cancer)
- Any patient/healthcare professional unable or unwilling to provide informed consent. Some patients undergoing emergency major lower limb amputation will have insufficient time to give informed consent
- Potential participants with an insufficient understanding of English or Welsh to be able to provide informed consent
- Potential participants unable to complete an interview in English
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
Analysis of audio-recorded consultations between surgeons and patients.
Time frame: During primary consultation
Theme-oriented discourse analysis
2 secondary outcomes
Analysis of patient interviews
Time frame: As soon as possible after the time of consultation and approximately 6 months following consultation
Analysis of healthcare professional interviews
Time frame: As soon as possible after the time of consultation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Derived from this study: PubMed 41526012Prout H, Waldron CA, Gwilym B, Thomas-Jones E, Milosevic S, Pallmann P, Harris D, Edwards A, Twine CP, Massey I, Burton J, Stewart P, Jones S, Cox D, Bosanquet DC, Brookes-Howell L; PERCEIVE Study group; PERCEIVE Study. Challenges in shared decision-making about major lower limb amputation: the PERCEIVE qualitative study. BMJ Open. 2026 Jan 12;16(1):e104407. doi: 10.1136/bmjopen-2025-104407.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Amputation and Peripheral Artery Disease, run by Aneurin Bevan University Health Board 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Analysis of audio-recorded consultations between surgeons and patients. (time frame: During primary consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04903756, which also lists 1 linked publication.
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 29 Jan 2025.