Neurostimulation for leg pain caused by poor circulation
Official title: The Effect of Neurostimulation on Patient Relevant Outcomes in Patients With Intermittent Claudication: a Pilot Study
Run by The Leeds Teaching Hospitals NHS Trust · NCT06176898 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing a new device that uses neurostimulation to help people with leg pain from poor circulation walk better and feel better overall without needing surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years to 90 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | The Leeds Teaching Hospitals NHS Trust Academic / other |
| Locations | 1 site (Leeds) |
| Trial ID | NCT06176898 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with Rutherford b/c intermittent claudication who have stable symptoms for at least six months and have chosen not to undergo revascularization.
✕Probably not a fit
Patients with critical limb ischemia or those with significant comorbidities that prevent them from participating in a walking test may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of a neurostimulating device to alleviate symptoms of intermittent claudication, a condition characterized by muscle pain in the legs due to inadequate blood flow. The research focuses on patients who have stable symptoms and have opted against invasive revascularization procedures. By employing a non-invasive approach, the study aims to improve patients' walking ability and overall quality of life without the risks associated with surgery. The study is conducted at the Leeds Teaching Hospitals NHS Trust, which is a prominent medical center in the UK.
Why it matters
Potential benefit: If successful, this approach could provide a safer, non-invasive treatment option for patients suffering from intermittent claudication.
How similar studies have gone: While the use of neurostimulation for claudication is a novel approach, similar non-invasive methods have shown promise in other vascular conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Rutherford b/c intermittent claudication with stable symptoms for 6 months with a decision not to undergo any revascularization. Exclusion Criteria: * • Critical limb ischaemia * Previous external ear surgery * Patients with either a cochlear implant or a permanent pacemaker / cardiac defibrillator device * Significant cardiorespiratory or musculoskeletal disease (as determined by the medical team) that would contraindicate a 6-minute walk test
Where it's running
-
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom Recruiting
Study contacts
- Study coordinator: Patrick Coughlin, Yes
- Email: patrick.coughlin1@nhs.net
- Phone: 0113 392 8160
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.