FraiLTI Study: Frailty in Chronic Limb Threatening Ischaemia
Research type
Research Study
Full title
A Multicentre Prospective observational study to investigate the prevalence and short-term impact of frailty in chronic limb threatening ischaemia (CLTI)
IRAS ID
294528
Contact name
Sandip Nandhra
Contact email
Sponsor organisation
Newcastle Upon Tyne University Hospitals
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
This is an observational study. Patients with vascular problems affecting the blood supply to their legs that results in constant pain or ulceration are a particular priority. Their limbs are at risk. Frailty is a condition of deconditioning, weakness, more general function and health, it typically affects older people. There is some evidence that frailty may lead to worse outcomes such as survival and complications in other areas of surgery.
Lower limb vascular disease termed chronic limb threatening ischaemia (CLTI) is a high risk condition, with patients having multiple associated health problems. It is not known whether these patients are frail, or weakened in the same way as older people. In addition at present we are not sure if the same risks that affect other frail patients apply in this group for vascular patients.
the multiple co-existing conditions are also associated with adverse outcomes in heart failure patients. The contribution of mulit-morbidity to outcome is poorly evaluated and understood in vascular care. This study presents the unique opportunity to evaluate these in high risk CLTI patients.
The FraiLTI study has been designed to observe patients with CLTI, assess and record their frailty scores by means of a grip strength assessment and then to use assessment calculations. These patients will then undergo their routine care. At 90 days the study will observe if there has been any adverse outcomes such as death, limb-loss and whether this is associated with frailty in any way. Patients will receive no intervention in the study context and this study will not interfere with routine care.
REC name
London - Hampstead Research Ethics Committee
REC reference
21/PR/0750
Date of REC Opinion
13 Jul 2021
REC opinion
Further Information Favourable Opinion