Critical Limb Threatening IschaemiaNCT07529886
Symptoms of Anxiety and/or Depression and SDM in Older Patients With CLTI
An observational study of Critical Limb Threatening Ischaemia and Depression Disorder, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Mental health disorders are common in older people and are often unrecognised. Those living with mental health disorders who are being considered for vascular surgery have worse post operative outcomes, including longer length of hospital stay, higher readmission rates and emergency admissions to hospital. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Limb Threatening Ischaemia, Depression Disorder, Anxiety
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients with symptoms of anxiety and/or depression living with critical limb threatening ischaemia (CLTI) being considered for surgical intervention Carers and staff looking after these patients
Who may be able to join
- Patients
- Aged ≥65 years old
- CLTI
- Active symptoms of anxiety or depression (clinician concern)
- Carers
- o In a non-paid caring role for a patient aged ≥65 years with CLTI and active symptoms of anxiety or depression
- Staff o Healthcare professional (vascular surgeons, therapists, clinical nurse specialists, geriatricians, anaesthetists, pharmacists) providing care for people aged ≥65 years with CLTI
Who cannot join
- Patients
- Palliative - death anticipated within one month
- Clinical and research team identify as lacking capacity to participate
- Carers
- o Clinical and research team identify as lacking capacity to participate
- Staff o Not providing care for older people with CLTI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE19RT
Bridget C Strasser, MBBS (Hons) MPHTM BSc, +44 20 7188 7188, b.strasser@nhs.net
About this study
Official title: Symptoms of Anxiety and/or Depression and the Shared Decision Making (SDM) Process in Older Patients With Critical Limb Threatening Ischaemia (CLTI)
Mental health disorders are common in older people and are often unrecognised. Those living with mental health disorders who are being considered for vascular surgery have worse post operative outcomes, including longer length of hospital stay, higher readmission rates and emergency admissions to hospital. These patients also have more medical conditions contributing to their post surgery complications and poor health outcomes.
Surgery for vascular patients can include life changing operations, such as amputation, which impacts mental health and quality of life.
Shared decision making is the process whereby patients and clinicians work together to make evidence based decisions centred on patient values and preferences and is part of the Comprehensive Geriatric Assessment and optimisation (CGA) model of care. SDM has been shown to improve patient experience through provision of realistic choice, enhanced interaction with clinicians, greater empowerment and increased confidence and trust in healthcare provision. Implementing SDM in vascular patients can be particularly challenging. Evaluating and communicating benefits and risks of available treatments for CLTI in a complex older patient population requires additional consideration beyond the inherent surgical risks. To achieve truly informed SDM, the clinician requires knowledge of the impact of co-existing conditions on postoperative recovery, the natural history of the surgical pathology with and without surgery and an awareness of the benefits and risks of alternative treatments underpinned by skilful communication.
Read the detailed description
Despite several studies associating mental health with both advancing age and poorer postoperative outcome, few studies have qualitatively explored the lived experience of older people with CLTI. Exploring the patient perspective will allow us to better understand the relationship between CLTI and mental health, and how patients can be better supported through SDM with the potential to reduce decisional regret. This will allow the development of strategies to enhance SDM taking mental health into account.
Study type This is a two-centre qualitative study, using a purposive sample from two NHS tertiary referral centres for vascular surgery (Guy's and St Thomas' NHS Foundation Trust and University Hospitals of Leicester). For this study, semi-structured interviews and a co-production workshop will be undertaken.
Public and patient involvement and engagement This study has been prompted by PPIE work informing the larger POPS-SUp study where patient and carer participants highlighted the need to explore mental health issues in a diverse surgical population with a focus on the impact this may have on SDM and recovery from surgery. The PPIE group told us that people with mental health issues can be especially stigmatised in some minority communities and approaching this topic in a sensitive manner will be key to this study. Following consultation, the investigators recognize the need to collaborate with organisations such as the Centre for Ethnic Health Research and consult a diverse PPI group (established from previous studies) to co-develop recruitment strategies and ensure interview questions are culturally sensitive and appropriate. The investigators have included a budget to translate study documents in two languages (Gujarati and Punjabi) and for a face-to-face interpreter for up to ten interviews to reduce language barriers to participation.
This study will draw on the diverse knowledge and expertise of existing PPIE groups in mental health and vascular surgery and from the existing POPS-SUp study. The investigators have costed for a PPIE representative to work with us specifically on this study who has experience of CLTI and mental health issues. JS will review study documents and be involved in the dissemination and coproduction workshop. The investigators will hold three PPIE meetings with five to six patient representatives, one to provide feedback on the protocol and other study documents, one during the study to discuss findings and dissemination plan (community talks, social media, lay summaries, infographics) and one toward the end of the study for feedback and guidance on next steps.
An appropriate budget has been included in this bid to support all stakeholder and public involvement and engagement activities, including dissemination.
Data collection Purposive sampling of patients/carers will ensure representation from different ethnic and socioeconomic backgrounds and surgical management (type of surgery or conservative management). Patients/carers will be identified and approached in the first instance by the clinical care team.
A purposive sample of 10-15 healthcare professionals (vascular surgeons, therapists, clinical nurse specialists, geriatricians, anaesthetists, pharmacists) providing care for older people (aged ≥65 years) on an inpatient vascular surgical ward will be invited to participate by the clinical or research team.
Risks, burdens and benefits The team acknowledge that such a discussion can be upsetting but have developed expertise to signpost patients, carers or family members to appropriate support if distress results from involvement in this study. Whilst acknowledging this potential distress the research team and PPIE partners are clear that the research aims could not be addressed without this component of the study. Some patient partners have also told us that they found the discussion of their decisional regret therapeutic in moving forward.
Staff interviewees may be hesitant to raise criticism or suggest failings of the clinical service. To address this, the participant information sheets will highlight that researchers are independent of those delivering care and that there are no right or wrong answers. The PIS highlights that information will be fully anonymised (including names and places) and will emphasise that the researchers want to learn about things that do not work well so that they can be improved in future.
- Keywords
- Shared decision making, Perioperative medicine, Geriatrics, Mental health problems, Vascular surgery
- Medical subject headings
- Anxiety Disorders
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 |
|---|---|---|
| 15 patients/carers with CLTI >=65 with symptoms of anxiety and/or depression | 15 staff members caring for patients with CLTI >=65 with symptoms of anxiety and/or depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and/or depression during the SDM process via semi structured interview
Semi structured interviews will be qualitatively analysed via thematic analysis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Critical Limb Threatening IschaemiaStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529886
- Sponsor's protocol ID
- 361194
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. BMJ Qual Saf. 2016 Dec;25(12):986-992. doi: 10.1136/bmjqs-2015-004411. Epub 2015 Sep 14.
PubMed 26369893Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.
PubMed 17872937O'Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: a synthesis of recommendations. Acad Med. 2014 Sep;89(9):1245-51. doi: 10.1097/ACM.0000000000000388.
PubMed 24979285Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
PubMed 23303884Paveley AM, Hall H, Mudford L, Partridge J, Dhesi J. Including the voice of older people in the co-design of perioperative pathways of care. Future Healthc J. 2023 Jul;10(2):143-146. doi: 10.7861/fhj.2023-0010.
PubMed 37786626Xu RH, Zhou LM, Wang D. The Relationship Between Decisional Regret and Well-Being in Patients With and Without Depressive Disorders: Mediating Role of Shared Decision-Making. Front Psychiatry. 2021 Jun 16;12:657224. doi: 10.3389/fpsyt.2021.657224. eCollection 2021.
PubMed 34220572Parmar KL, Law J, Carter B, Hewitt J, Boyle JM, Casey P, Maitra I, Farrell IS, Pearce L, Moug SJ; ELF Study Group. Frailty in Older Patients Undergoing Emergency Laparotomy: Results From the UK Observational Emergency Laparotomy and Frailty (ELF) Study. Ann Surg. 2021 Apr 1;273(4):709-718. doi: 10.1097/SLA.0000000000003402.
PubMed 31188201Wukich DK, Raspovic KM, Suder NC. Patients With Diabetic Foot Disease Fear Major Lower-Extremity Amputation More Than Death. Foot Ankle Spec. 2018 Feb;11(1):17-21. doi: 10.1177/1938640017694722. Epub 2017 Feb 1.
PubMed 28817962Wann-Hansson C, Rahm Hallberg I, Klevsgard R, Andersson E. The long-term experience of living with peripheral arterial disease and the recovery following revascularisation: a qualitative study. Int J Nurs Stud. 2008 Apr;45(4):552-61. doi: 10.1016/j.ijnurstu.2006.11.006. Epub 2007 Feb 5.
PubMed 17280672Ostler C, Ellis-Hill C, Donovan-Hall M. Expectations of rehabilitation following lower limb amputation: a qualitative study. Disabil Rehabil. 2014;36(14):1169-75. doi: 10.3109/09638288.2013.833311. Epub 2013 Sep 11.
PubMed 24024542Essien SK, Kopriva D, Linassi AG, Zucker-Levin A. Trends of limb amputation considering type, level, sex and age in Saskatchewan, Canada 2006-2019: an in-depth assessment. Arch Public Health. 2022 Jan 4;80(1):10. doi: 10.1186/s13690-021-00759-1.
PubMed 34983652Butala NM, Raja A, Xu J, Strom JB, Schermerhorn M, Beckman JA, Shishehbor MH, Shen C, Yeh RW, Secemsky EA. Association of Frailty With Treatment Selection and Long-Term Outcomes Among Patients With Chronic Limb-Threatening Ischemia. J Am Heart Assoc. 2021 Dec 21;10(24):e023138. doi: 10.1161/JAHA.121.023138. Epub 2021 Dec 16.
PubMed 34913364Houghton JS, Nickinson AT, Helm JR, Dimitrova J, Dubkova S, Rayt HS, Gray LJ, Haunton VJ, Davies RS, Sayers RD. Associations of Clinical Frailty with Severity of Limb Threat and Outcomes in Chronic Limb-threatening Ischaemia. Ann Vasc Surg. 2021 Oct;76:406-416. doi: 10.1016/j.avsg.2021.04.017. Epub 2021 May 2.
PubMed 33951523King AP, Abelson JL, Gholami B, Upchurch GR Jr, Henke P, Graham L, Liberzon I. Presurgical Psychological and Neuroendocrine Predictors of Psychiatric Morbidity After Major Vascular Surgery: A Prospective Longitudinal Study. Psychosom Med. 2015 Nov-Dec;77(9):993-1005. doi: 10.1097/PSY.0000000000000235.
PubMed 26461854Darnall BD, Ephraim P, Wegener ST, Dillingham T, Pezzin L, Rossbach P, MacKenzie EJ. Depressive symptoms and mental health service utilization among persons with limb loss: results of a national survey. Arch Phys Med Rehabil. 2005 Apr;86(4):650-8. doi: 10.1016/j.apmr.2004.10.028.
PubMed 15827913
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms of Anxiety and/or Depression and the Shared Decision Making (SDM) Process in Older Patients With Critical Limb Threatening Ischaemia (CLTI)
- ClinicalTrials.gov ID
- NCT07529886
- Acronym / sponsor ID
- 361194
- Keywords
- Shared decision making, Perioperative medicine, Geriatrics, Mental health problems, Vascular surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Apr 2026 (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.
Mental health disorders are common in older people and are often unrecognised. Those living with mental health disorders who are being considered for vascular surgery have worse post operative outcomes, including longer length of hospital stay, higher readmission rates and emergency admissions to hospital. These patients also have more medical conditions contributing to their post surgery complications and poor health outcomes.
Surgery for vascular patients can include life changing operations, such as amputation, which impacts mental health and quality of life.
Shared decision making is the process whereby patients and clinicians work together to make evidence based decisions centred on patient values and preferences and is part of the Comprehensive Geriatric Assessment and optimisation (CGA) model of care. SDM has been shown to improve patient experience through provision of realistic choice, enhanced interaction with clinicians, greater empowerment and increased confidence and trust in healthcare provision. Implementing SDM in vascular patients can be particularly challenging. Evaluating and communicating benefits and risks of available treatments for CLTI in a complex older patient population requires additional consideration beyond the inherent surgical risks. To achieve truly informed SDM, the clinician requires knowledge of the impact of co-existing conditions on postoperative recovery, the natural history of the surgical pathology with and without surgery and an awareness of the benefits and risks of alternative treatments underpinned by skilful communication.
Detailed description
Despite several studies associating mental health with both advancing age and poorer postoperative outcome, few studies have qualitatively explored the lived experience of older people with CLTI. Exploring the patient perspective will allow us to better understand the relationship between CLTI and mental health, and how patients can be better supported through SDM with the potential to reduce decisional regret. This will allow the development of strategies to enhance SDM taking mental health into account.
Study type This is a two-centre qualitative study, using a purposive sample from two NHS tertiary referral centres for vascular surgery (Guy's and St Thomas' NHS Foundation Trust and University Hospitals of Leicester). For this study, semi-structured interviews and a co-production workshop will be undertaken.
Public and patient involvement and engagement This study has been prompted by PPIE work informing the larger POPS-SUp study where patient and carer participants highlighted the need to explore mental health issues in a diverse surgical population with a focus on the impact this may have on SDM and recovery from surgery. The PPIE group told us that people with mental health issues can be especially stigmatised in some minority communities and approaching this topic in a sensitive manner will be key to this study. Following consultation, the investigators recognize the need to collaborate with organisations such as the Centre for Ethnic Health Research and consult a diverse PPI group (established from previous studies) to co-develop recruitment strategies and ensure interview questions are culturally sensitive and appropriate. The investigators have included a budget to translate study documents in two languages (Gujarati and Punjabi) and for a face-to-face interpreter for up to ten interviews to reduce language barriers to participation.
This study will draw on the diverse knowledge and expertise of existing PPIE groups in mental health and vascular surgery and from the existing POPS-SUp study. The investigators have costed for a PPIE representative to work with us specifically on this study who has experience of CLTI and mental health issues. JS will review study documents and be involved in the dissemination and coproduction workshop. The investigators will hold three PPIE meetings with five to six patient representatives, one to provide feedback on the protocol and other study documents, one during the study to discuss findings and dissemination plan (community talks, social media, lay summaries, infographics) and one toward the end of the study for feedback and guidance on next steps.
An appropriate budget has been included in this bid to support all stakeholder and public involvement and engagement activities, including dissemination.
Data collection Purposive sampling of patients/carers will ensure representation from different ethnic and socioeconomic backgrounds and surgical management (type of surgery or conservative management). Patients/carers will be identified and approached in the first instance by the clinical care team.
A purposive sample of 10-15 healthcare professionals (vascular surgeons, therapists, clinical nurse specialists, geriatricians, anaesthetists, pharmacists) providing care for older people (aged ≥65 years) on an inpatient vascular surgical ward will be invited to participate by the clinical or research team.
Risks, burdens and benefits The team acknowledge that such a discussion can be upsetting but have developed expertise to signpost patients, carers or family members to appropriate support if distress results from involvement in this study. Whilst acknowledging this potential distress the research team and PPIE partners are clear that the research aims could not be addressed without this component of the study. Some patient partners have also told us that they found the discussion of their decisional regret therapeutic in moving forward.
Staff interviewees may be hesitant to raise criticism or suggest failings of the clinical service. To address this, the participant information sheets will highlight that researchers are independent of those delivering care and that there are no right or wrong answers. The PIS highlights that information will be fully anonymised (including names and places) and will emphasise that the researchers want to learn about things that do not work well so that they can be improved in future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 15 patients/carers with CLTI >=65 with symptoms of anxiety and/or depression | – | –15 staff members caring for patients with CLTI >=65 with symptoms of anxiety and/or depression |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients with symptoms of anxiety and/or depression living with critical limb threatening ischaemia (CLTI) being considered for surgical intervention Carers and staff looking after these patients
Key inclusion criteria (7 listed)
- Patients
- Carers
- o In a non-paid caring role for a patient aged ≥65 years with CLTI and active symptoms of anxiety or depression
- Staff o Healthcare professional (vascular surgeons, therapists, clinical nurse specialists, geriatricians, anaesthetists, pharmacists) providing care for people aged ≥65 years with CLTI
Key exclusion criteria (6 listed)
- Patients
- Carers
- o Clinical and research team identify as lacking capacity to participate
- Staff o Not providing care for older people with CLTI
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
Anxiety and/or depression during the SDM process via semi structured interview
Time frame: 6 months
Semi structured interviews will be qualitatively analysed via thematic analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 26369893Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. BMJ Qual Saf. 2016 Dec;25(12):986-992. doi: 10.1136/bmjqs-2015-004411. Epub 2015 Sep 14.
- Background: PubMed 17872937Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.
- Background: PubMed 24979285O'Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: a synthesis of recommendations. Acad Med. 2014 Sep;89(9):1245-51. doi: 10.1097/ACM.0000000000000388.
- Background: PubMed 23303884Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
- Background: PubMed 37786626Paveley AM, Hall H, Mudford L, Partridge J, Dhesi J. Including the voice of older people in the co-design of perioperative pathways of care. Future Healthc J. 2023 Jul;10(2):143-146. doi: 10.7861/fhj.2023-0010.
- Background: PubMed 34220572Xu RH, Zhou LM, Wang D. The Relationship Between Decisional Regret and Well-Being in Patients With and Without Depressive Disorders: Mediating Role of Shared Decision-Making. Front Psychiatry. 2021 Jun 16;12:657224. doi: 10.3389/fpsyt.2021.657224. eCollection 2021.
- Background: PubMed 31188201Parmar KL, Law J, Carter B, Hewitt J, Boyle JM, Casey P, Maitra I, Farrell IS, Pearce L, Moug SJ; ELF Study Group. Frailty in Older Patients Undergoing Emergency Laparotomy: Results From the UK Observational Emergency Laparotomy and Frailty (ELF) Study. Ann Surg. 2021 Apr 1;273(4):709-718. doi: 10.1097/SLA.0000000000003402.
- Background: PubMed 28817962Wukich DK, Raspovic KM, Suder NC. Patients With Diabetic Foot Disease Fear Major Lower-Extremity Amputation More Than Death. Foot Ankle Spec. 2018 Feb;11(1):17-21. doi: 10.1177/1938640017694722. Epub 2017 Feb 1.
- Background: PubMed 17280672Wann-Hansson C, Rahm Hallberg I, Klevsgard R, Andersson E. The long-term experience of living with peripheral arterial disease and the recovery following revascularisation: a qualitative study. Int J Nurs Stud. 2008 Apr;45(4):552-61. doi: 10.1016/j.ijnurstu.2006.11.006. Epub 2007 Feb 5.
- Background: PubMed 24024542Ostler C, Ellis-Hill C, Donovan-Hall M. Expectations of rehabilitation following lower limb amputation: a qualitative study. Disabil Rehabil. 2014;36(14):1169-75. doi: 10.3109/09638288.2013.833311. Epub 2013 Sep 11.
- Background: PubMed 34983652Essien SK, Kopriva D, Linassi AG, Zucker-Levin A. Trends of limb amputation considering type, level, sex and age in Saskatchewan, Canada 2006-2019: an in-depth assessment. Arch Public Health. 2022 Jan 4;80(1):10. doi: 10.1186/s13690-021-00759-1.
- Background: PubMed 34913364Butala NM, Raja A, Xu J, Strom JB, Schermerhorn M, Beckman JA, Shishehbor MH, Shen C, Yeh RW, Secemsky EA. Association of Frailty With Treatment Selection and Long-Term Outcomes Among Patients With Chronic Limb-Threatening Ischemia. J Am Heart Assoc. 2021 Dec 21;10(24):e023138. doi: 10.1161/JAHA.121.023138. Epub 2021 Dec 16.
- Individual participant dataSharing planned: Undecided
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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.
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 Critical Limb Threatening Ischaemia and Depression Disorder, run by Guy's and St Thomas' NHS Foundation Trust 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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bridget C Strasser, MBBS (Hons) MPHTM BSc (+44 20 7188 7188, b.strasser@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and/or depression during the SDM process via semi structured interview (time frame: 6 months). 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 NCT07529886, which also lists 18 linked publications.
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 17 Apr 2026.