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NCT04027244: LIMb
Leg Ischaemia Management Collaboration
trial in Peripheral Arterial Disease in 420 participants. Currently enrolling.
9 May 2022
Quick facts
| Lead sponsor | University of Leicester |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 420 |
| Start date | 10 May 2019 |
| Primary completion | 9 May 2022 |
| Estimated completion | 9 May 2031 |
| Sites | 1 location across United Kingdom |
Conditions studied
- Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
- Critical Limb Ischemia — all drugs for Critical Limb Ischemia →
- Frailty — all drugs for Frailty →
- Cognitive Impairment — all drugs for Cognitive Impairment →
Sponsor
University of Leicester
Who can join
Adults 18 to 110, any sex, with Peripheral Arterial Disease or Critical Limb Ischemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Single-centre prospective cohort study of patients presenting with severe limb ischaemia (SLI). The primary outcome measure will be 12 month major amputation rate. A historical cohort of patients identified retrospectively will be the comparitor group used to assess the impact of a newly-established rapid-access limb salvage clinic. Primary aim: \- Determine the proportion of patients with SLI undergoing major lower limb amputation within 12 months of presentation. Secondary aims: * Assess clinically important short-, medium- and long-term outcomes in those undergoing and not undergoing amputation * Prevalence and degree of frailty and cognitive impairment * Pevalence and degree of cardiac disease (detected by stress MRI) * Establish a biobank for future biomarker analysis * Investigate the role of frailty and cognitive assessments, cardiac MRI and biomarkers in risk-stratification of patients with SLI
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
A systematic review of patient-reported outcome measures patients with chronic limb-threatening ischemia.
Goodney P, Shah S, Hu YD, Suckow B, et al · · 2022 · cited 23× · PMID 35085747 · DOI 10.1016/j.jvs.2021.11.057 -
Leg ischaemia management collaboration (LIMb): study protocol for a prospective cohort study at a single UK centre.
Houghton JSM, Nduwayo S, Nickinson ATO, Payne TJ, et al · · 2019 · cited 7× · PMID 31481569 · DOI 10.1136/bmjopen-2019-031257 -
Relationship of the Wound, Ischemia, and Foot Infection Stage with Frailty, Disability, Quality of Life, and One-Year Outcomes in All-Comers with Chronic Limb-Threatening Ischemia: Single-Center Prospective Cohort Study.
Houghton JSM, Black I, Meffen A, Gray LJ, et al · · 2026 · cited 1× · PMID 41271091 · DOI 10.1016/j.avsg.2025.11.008
Verify or expand the search:
- PubMed search for NCT04027244
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Peripheral Arterial Disease
Currently open trials in the same condition.
- NCT05437562 — Randomized Clinical Trial for Ewing Amputation in the VA · NA · recruiting
- NCT07427108 — Road Mapping Guided Puncture Versus Ultrasound Guided Puncture During Retrograde Angioplasty Feasibility and Safety · NA · recruiting
- NCT07336381 — Replexa+ Shortwave Diathermy Device for Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy · NA · recruiting
- NCT07076082 — Vascular Trial Associated Registry Pilot · Phase 4 · recruiting
- NCT06308562 — Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease · NA · recruiting
Other University of Leicester trials
Trials by the same sponsor.
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- NCT07014579 — Using Heart Electrical Signals to Study How Well Treatments Prevent Dangerous Heart Rhythms in Active People · not yet recruiting
- NCT06955663 — Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection · NA · recruiting
- NCT06629675 — Make Every Step Count: Personalised Music Feedback to Walking for People Living With COPD · NA · recruiting
- NCT06844656 — Understanding the Increased Risk of Atrial Fibrillation in Athletes: a Case-control Study · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04027244 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Leicester
- Last refreshed: 4 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04027244.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing