Heat Therapy for Peripheral Arterial Disease (HEATPAD)

Launched by NORFOLK AND NORWICH UNIVERSITY HOSPITALS NHS FOUNDATION TRUST · Dec 15, 2023

Keywords

ClinConnect Summary

The HEATPAD clinical trial is studying a new device called the AirGlove, which uses heat therapy to help improve blood flow in people with Peripheral Arterial Disease (PAD). PAD can cause painful cramping in the legs during activities, significantly impacting daily life. This trial will take place in three parts: First, healthy volunteers will test the device to see how it affects blood flow and overall comfort. Next, individuals aged 60 or older with a specific type of PAD called intermittent claudication will try the device both in a single session and over a 12-week period. Lastly, participants with a more severe condition, critical limb ischemia, will also use the device, and their blood flow and pain levels will be monitored.

To be eligible for the trial, participants in the first phase need to be healthy adults aged 18 or older. For the second and third phases, participants must be 60 or older and have specific symptoms of PAD. Everyone in the trial will be closely monitored for the effects of the AirGlove device on their leg blood flow, pain, and quality of life. It's important to note that there are some exclusions, such as having certain medical conditions or recent surgeries. This trial is not yet recruiting participants, but it aims to provide valuable insights into how heat therapy can help those suffering from PAD.

Gender

ALL

Eligibility criteria

• 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