Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06186505
NA

Heat Therapy for Peripheral Arterial Disease (HEATPAD)

Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust

View on ClinicalTrials.gov

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 device improves participants circulation. This is phase 1 study and will be taken in 3 parts: Phase 1a will be undertaken in 10 healthy volunteers to assess the effects of the AirGlove device on lower limb arterial flow, tissue perfusion, quality of life and product usability following a single session. Phase 1b will be undertaken in 20 participants with intermittent claudication to assess the effects of the AirGlove device on lower limb arterial flow, tissue perfusion, quality of life and product usability both in a single session and following a 12-week trial of heat therapy. Phase 1c will be undertaken in 10 participants with critical limb ischaemia Rutherford stage 4 (rest pain). Lower limb arterial flow, tissue perfusion, pain scores, quality of life, and product usability will be assessed both in a single session and following a 2-12 week trial of heat therapy.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-01-01

Completion Date

2028-12-31

Last Updated

2024-01-02

Healthy Volunteers

Yes

Interventions

DEVICE

AirGlove

AirGlove is a unique warming system developed to enable access to the veins in a patients arm for the delivery of intraveneous drugs by gently heating the patients arm up as it forces warm air through a double walled polythene glove. In this study, the device will be used on the leg of the participants as means of encouraging circulation to the area.