Heat Therapy for Peripheral Arterial Disease (HEATPAD)
Megadott ok: Abandoned as the team couldn't get the design right for the product to work to be able to use it for the study.
A vizsgálat adatai
- Ki végzi
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Azonosító
- NCT06186505
- A regiszteradat frissítve
- 2026. június 9.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Kizáró feltételek: undergone previous surgical or endovascular intervention for peripheral arterial or endovascular intervention for peripheral arterial disease; Has known allergy to any trial product; Aged under 60 years (for Phase 1b and 1c only); Alternative cause of leg pain; Requires urgent revascularisation (<2 weeks); Significant leg ulceration/necrosis.
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.