How do frailty, muscle strength and multiple health conditions affect outcomes (survival, limb loss and return to normal function) for patients with longstanding circulatory problems in the lower limbs?
| ISRCTN | ISRCTN18644880 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18644880 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 294528 |
| Protocol serial number | CPMS 49622, IRAS 294528 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust |
| Funder | NIHR Newcastle Biomedical Research Centre |
- Submission date
- 06/09/2021
- Registration date
- 25/10/2021
- Last edited
- 25/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
In this study the researchers want to find out if there are any routine bedside tests or tests used in everyday care that might suggest that patients are at an increased risk of poorer outcomes. One of the conditions known to influence outcome is frailty. Frailty is a mix of a reduction in function of multiple areas such as muscle strength, movement and other medical problems. These all contribute to less effective recovery and outcome in other areas of medicine and surgery. There may be a similar problem that is not yet fully understood for patients with blood supply issues affecting the lower legs (termed chronic limb-threatening ischaemia [CLTI]). The researchers hope to find out how many patients are affected by frailty and if there are any links with the outcome of their care for the lower limb blood supply.
Who can participate?
Patients aged over 18 years with a leg wound (ulcer), constant pain at rest or gangrene, due to vascular (circulatory) disease
What does the study involve?
The researchers will collect details about the participants (age, sex, weight, height) and the surgery they will receive, as well as carry out routine blood tests. Their current level of frailty will be assessed through a physical test and through routine (CT) medical imaging (if performed). The physical test will involve a grip strength assessment and a five times sit-to-stand test, where participants will be asked to stand up from a chair and sit back down a total of five times (if they can). The medical imaging will involve a CT scan to assess for the muscle mass in the back and the affected limb. The researchers will also use the ultrasound scan images that will routinely be carried out to look at the blood supply in the limbs. The researchers will then observe the participant's recovery following their procedure, taking note of their recovery time and overall progress. Participants will be invited to fill out a questionnaire 90 days after their procedure, which they can either complete through the telephone or through the post. The questionnaire will be a widely utilised health survey looking at their current wellbeing. The researchers will also see participants back in the clinic as per routine care.
What are the possible benefits and risks of participating?
The information from this study will be useful to improve the overall quality of care for future patients diagnosed with chronic limb-threatening ischaemia. The results are likely to improve care not only in the local area, but also nationally. Being part of a study also means that there is extra healthcare input compared to standard care. There would be no significant disadvantages or risks in taking part in the study. Participants will be receiving the same care as before, and all the data collected will be anonymised.
Where is the study run from?
Freeman Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2019 to September 2022
Who is funding the study?
NIHR Biomedical Research Centre Newcastle (UK)
Who is the main contact?
Sandip Nandhra
sandip.nandhra@nhs.net
Contact information
Scientific
Northern Vascular Centre
Newcastle University
Level 4, Freeman Hospital
Newcastle
NE7 7DN
United Kingdom
 ORCID ID |
0000-0002-6036-5760 |
|---|---|
| Phone | +44 (0)191 233 6161 - switchboard |
| sandip.nandhra@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational; Design type: Cross-sectional |
| Secondary study design | Cross sectional study |
| Participant information sheet | 40373_PIS_V1.2_01Jul21.pdf |
| Scientific title | A multicentre prospective observational study to investigate the prevalence and short-term impact of frailty in chronic limb-threatening ischaemia |
| Study acronym | FraiLTI |
| Study objectives | Patients with chronic-limb threatening ischaemia (CLTI) are venerable to limb loss and premature death. Due to the nature of vascular disease CLTI patients often have multiple long-term conditions. The interaction of these conditions leaves patients at risk of frailty and deconditioning. It is expected that patients with multiple conditions and/or frailty might have worse clinical outcomes. They may well be more susceptible to limb loss, perhaps death and other complications. Potentially they may too be unable to return to their home environment. The FraiLTI study hopes to understand this interaction and highlight key areas for potential optimisation research. |
| Ethics approval(s) | Approved 13/07/2021, Health Research Authority (HRA) and Health and Care Research Wales (HCRW, Ground Floor, Temple Quay House, Health Research Authority, BS1 6PN, UK; +44 (0)207 104 8328; approvals@hra.nhs.uk), REC ref: 21/PR/0750 |
| Health condition(s) or problem(s) studied | Chronic limb-threatening ischaemia |
| Intervention | All patients admitted with chronic limb-threatening ischaemia (CLTI) to a dedicated vascular centre will be invited to participate. Confirmation of CLTI diagnosis will be made by the admitting vascular specialist. These will then be screened according to the inclusion and exclusion criteria. Patients meeting the below inclusion criteria will be invited to participate in the FraiLTI study. Patients will undergo routine care in the hospital. On admission, patients will be first notified about the study by a member of the clinical team. If potential participants are interested and would like more information verbal consent for their details to be shared with the FraiLTI (local site academic or clinical academic team). At this point a member of the FraiLTI study team (on the delegation log and meeting GCP etc) will approach the patient to provide the details of the study, PIS etc. After a period of typically 24 hours a study team member will consent the patient formally for participation. Routine data will be collected that is already part of the admission process (no new blood tests or scans). In addition, the EQ5D Quality of Life assessment will be made at baseline. Two functional assessments will be made: Grip strength and sit/stand test. This will provide data on frailty. Thereafter if the patients undergo a CT (as per their routine care - no additional imaging) these will be used to measure muscle area. After this patients will then continue on their routine care journey. On discharge, their admission length, surgical procedure and outcomes will be recorded. At 90 days patients will be reviewed electronically to record and adverse outcomes in line with the follow-up data. Patients will be invited to complete an EQ5D Quality of life assessment over the telephone. |
| Intervention type | Other |
| Primary outcome measure(s) | The prevalence of frailty measured using the Fried Frailty Score at baseline |
| Key secondary outcome measure(s) | Measured using patient records: 1. Major cardiovascular events (MACE) recorded according to standard international definitions and occurring within 90 days follow-up 2. Major adverse limb events (major amputation, trans-femoral, through knee or trans-tibial) occurring within 90 days 3. Survival measured by record of date of death up to 90 days follow-up 4. Re-interventions defined as the number of times within 90 days that repeat surgery or procedure (open or endovascular) is required 5. Length of stay in days up to 90 days 6. Discharge home or to another care environment within 90 days |
| Completion date | 01/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. All adults aged over 18 years, able to consent and participate with ongoing assessments 2. All chronic limb-threatening ischaemia patients with specifically: 2.1. Tissue loss 2.2. Rest-pain |
| Key exclusion criteria | 1. Admissions for non CLTI 2. Unable to agree to assessments or participate in study assessments 3. Pregnant women 4. Under 18 years of age |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 01/06/2022 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
- Scotland
- Wales
Study participating centres
Caerleon
Newport
NP18 3XQ
United Kingdom
Hull
HU3 2JZ
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Leeds
LS9 7TF
United Kingdom
Bristol
BS1 3NU
United Kingdom
London
W2 1BL
United Kingdom
Leicester
LE1 5WW
United Kingdom
Edgbaston
Birmingham
B15 2GW
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Liverpool
L7 8XP
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Saintfield Road
Belfast
BT8 8BH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version 1.2 | 01/07/2021 | 10/09/2021 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 2.0 | 01/07/2021 | 10/09/2021 | No | No |
Additional files
Editorial Notes
06/09/2021: Trial's existence confirmed by the NIHR.
