Status:
NOT_YET_RECRUITING
Heat Therapy for Peripheral Arterial Disease (HEATPAD)
Lead Sponsor:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborating Sponsors:
GreenCross Medico Limited
Conditions:
Peripheral Arterial Disease
Intermittent Claudication
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Peripheral arterial disease (PAD) is a disabling condition, with symptoms of muscle cramping or pain on exertion, which can substantially reduce quality of life. This study aims to see if AirGlove dev...
Detailed Description
As people get older, the blood supply to the legs can get worse. This is caused by blockages in the main blood vessels in the leg. If left to get worse this can progress to ulcers and amputation. If t...
Eligibility Criteria
Inclusion
- Participants in Phase 1a will be healthy volunteers. The inclusion criteria for this cohort are:
- Aged 18 or over
- ABPI within normal range (0.9 - 1.2)
- Negative Edinburgh Claudication Questionnaire
- For Phase 1b and 1c inclusion criteria are:
- Capacity to provide informed consent
- Aged 60 or over
- ABPI \<0.9
- Positive Edinburgh Claudication Questionnaire
- Exclusion Criteria:
- Aged under 60 years (for Phase 1b and 1c only)
- Has known allergy to any trial product
- undergone previous surgical or endovascular intervention for peripheral arterial or endovascular intervention for peripheral arterial disease
- Alternative cause of leg pain
- Requires urgent revascularisation (\<2 weeks)
- Significant leg ulceration/necrosis
Exclusion
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06186505
Start Date
January 1 2025
End Date
December 31 2028
Last Update
January 2 2024
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