Neurostimulation for leg pain caused by poor circulation
The Effect of Neurostimulation on Patient Relevant Outcomes in Patients With Intermittent Claudication: a Pilot Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | The Leeds Teaching Hospitals NHS Trust Academic / other |
| Locations | 1 site (Leeds) |
| Trial ID | NCT06176898 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While the use of neurostimulation for claudication is a novel approach, similar non-invasive methods have shown promise in other vascular conditions.
Eligibility criteria
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 this trial is running
Leeds
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.