Healthy volunteers test devices that boost leg circulation
NCT ID NCT06590610
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how two devices—a radial pressure wave device (RPW2) and a TENS unit—temporarily change blood flow in the lower leg. Twenty healthy adults in the UK received both treatments, and their blood flow was measured with ultrasound before, during, and after each session. The goal was to gather safety and performance data, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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20 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Nov 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects, both male and female, ≥ 18 years of age at the time of consent. 2. Subject is available to attend all study appointments for the study duration 3. Any Subject who has reviewed the IEC-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the Ethics-approved consent form. Exclusion Criteria: 1. Subjects with any cognitive impairment who prevent to understand the information provided and freely and autonomously provide and sign informed consent to participate in the study. 2. Subject is pregnant or has plans of becoming pregnant for the duration of the study. 3. Presence of cancerous tumours/Neoplastic tissue/lesions in treatment area (back lower limb of both legs) 4. Subject possesses a prosthetic lower limb 5. Diagnosed with diabetes 6. Cortisone therapy ongoing or within the last 6 months before treatment 7. Diagnosed Haemophilia, Thrombosis, Deep vein thrombosis, phlebitis, varices, risk of haemorrhage, occlusive vascular disease or other coagulation disorders 8. Treatment with anticoagulant pharmaceuticals 9. Reduced sensitivity over the proposed area of treatment (back lower limb of both legs) 10. Suspected or diagnosed cardiopathy 11. Any history of cardiovascular disease e.g., cardiac arrhythmia and angina pectoris, arterial disease, circulatory insufficiency. 12. Implanted electronic devices e.g., cardiac stimulator, implanted defibrillator or other implanted electronic/electrical device 13. Hypertension (\> stage 2), ischemic heart disease and cerebrovascular diseases 14. Peripheral vascular disease or serious arterial or venous circulation problems in any of the lower limbs. 15. Systemic or local infection. 16. Open wounds, rashes, swollen, red, infected, inflamed areas or skin eruptions at the site of treatment (back lower limb of both legs). 17. Diagnosis of Epilepsy or has had any previous Epileptic episodes. 18. Proven allergy to the study devices materials or electrodes. 19. Recent surgery or metal implant present at the site of treatment (back lower limb of both legs)
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Whiteley Clinic
Guildford, GU2 7RF, United Kingdom
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