Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT06114732
Eligibility Criteria:
Inclusion 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06114732
Study Brief:
Protocol Section:
NCT06114732