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New treatment option for Peripheral Artery Disease
Official title Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in Intermittent Claudication
ClinicalTrials.gov ID: NCT06114732
What this study is testing
- What it's testing
- Peripheral Arterial Disease (PAD) is a common vascular disease which commonly causes limb pain and reduced exercise tolerance termed Intermittent Claudication (IC). People with PAD and IC have impaired quality of life, reduced walking ability, and increased mortality compared to those who do not have the condition.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinical diagnosis of symptomatic Peripheral Arterial Disease (PAD) including resting ABPI \<0.9 in at least one leg
- Stable IC for ≥3 months
- Walking limited primarily by claudication
- Able to read and speak English to a level allowing satisfactory completion of the study procedures
- Able to provide written informed consent for participation
You likely can't join if
- Planned surgical or endovascular intervention for PAD within the next 3 months
- Critical limb ischaemia
- The presence of any absolute contraindications to exercise testing/training as defined by the American College of Sports Medicine (ACSM)
- Previous experience of using TENS for PAD
- Contraindications to TENS (including epilepsy, dermatological conditions, indwelling electrical pumps/pacemakers) and inability to apply TENS...
- Patients who require walking aids including artificial limbs
See the full eligibility criteria
- Clinical diagnosis of symptomatic Peripheral Arterial Disease (PAD) including resting ABPI \<0.9 in at least one leg
- Stable IC for ≥3 months
- Walking limited primarily by claudication
- Able to read and speak English to a level allowing satisfactory completion of the study procedures
- Able to provide written informed consent for participation
- Planned surgical or endovascular intervention for PAD within the next 3 months
- Critical limb ischaemia
- The presence of any absolute contraindications to exercise testing/training as defined by the American College of Sports Medicine (ACSM)
- Previous experience of using TENS for PAD
- Contraindications to TENS (including epilepsy, dermatological conditions, indwelling electrical pumps/pacemakers) and inability to apply TENS independently.
- Patients who require walking aids including artificial limbs
- Major surgery, myocardial infarction or stroke/ TIA in the previous 6 months
- Co-morbidities that cause pain or limit walking to a greater extent than IC (e.g. severe arthritis, respiratory conditions)
- Severe peripheral neuropathies above the ankle.
- Participation in another research protocol
The study team makes the final eligibility decision.
Where it's taking place
- Glasgow, Lanarkshire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glasgow, Lanarkshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.