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?

A multicentre prospective observational study to investigate the prevalence and short-term impact of frailty in chronic limb-threatening ischaemia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN18644880

Enrollment

300

Registered

2021-10-25

Start date

2021-10-01

Completion date

Unknown

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic limb-threatening ischaemia Circulatory System

Interventions

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 vascula

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The prevalence of frailty measured using the Fried Frailty Score at baseline	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Northern Ireland, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026