Peripheral Arterial DiseaseHEATPADNCT06186505
Heat Therapy for Peripheral Arterial Disease (HEATPAD)
A study testing AirGlove in people with Peripheral Arterial Disease and Intermittent Claudication, run by Norfolk and Norwich University Hospitals NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Intermittent Claudication, Critical Limb Ischemia
- What is being tested?
- AirGlove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
About this study
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.
Read the 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 treated early the blood supply can be improved. Currently patients are advised to exercise to improve their blood supply, however not all patients can do this. Recent work has shown that heat treatment could have a benefit in these patients to help improve walking distance and lower the risk of amputation. The studies so far have been limited to a one-off treatment, typically to the whole body rather than the affected leg. This study aims to use a device to warm the lower leg for a set amount of timeper day. The research team will look at the improvement in their walking distance and blood supply to the leg over a 12 week period.
The first phase of this study will be in healthy volunteers. They will undergo the trial protocol in a single session to assess acceptability of the trial protocol and identify potential barriers.
All patients invited into this study will be given the heat therapy device called AirGlove. This slides over the lower leg like a large sock, and hot air circulates within the sock itself. The research team will teach the patient how to use the device and they will then take it home for 12 weeks. At the start and end of the study patients will undergo tests to assess their walking distance, quality of life, pain, and to assess how much blood is getting down their leg.
This study will look at the role of heat therapy as an alternative to help improve their walking, potentially reducing the need for surgery, and saving legs.
- Being tested
- AirGlove
- Keywords
- Healthy volunteers, AirGlove, Heat therapy, Walking distance
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Chronic Limb-Threatening Ischemia, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirGloveDevice
Also called GB001
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a | Experimental | Phase 1a will be undertaken in 10 healthy volunteers to assess the effects of the AirGlove device on lower limb arterial flow, tissue perfusion, and product usability following a single session. Measurements will be taken just prior to device application, and then again at the time of device removal. Receives: Device: AirGlove |
| Phase 1b | Experimental | Phase 1b will be undertaken in 20 PAD patients 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. Measurements will be taken just prior to device application, and then again at the time of device removal at the start of the trial, and again at week 12 (in line with the recommended duration of SET). Receives: Device: AirGlove |
| Phase 1c | Experimental | Phase 1c will be undertaken in 10 PAD patients 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. Receives: Device: AirGlove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking distance.
Participants in phase 1b and 1c will undergo a 6-minute walk test to measure the initial claudication distance and maximum claudication distance.
Measured: Participants in phases 1b and 1c will be measured at baseline and at a 12-week follow up visit. Participants in phase 1c will additionally have their walking distance measured at visits at 3 and 6 weeks.
Secondary outcomes (5)
Change in tissue perfusion.
A laser doppler flowmeter will be used to measure change in tissue perfusion.
Measured: Participants in phases 1b and 1c will be measured at baseline and at a 12-week follow up visit. Participants in phase 1c will additionally be measured at visits at 3 and 6 weeks.
Change in arterial blood flow.
A doppler ultrasound will be used to measure blood volume flow and time adjusted mean velocity in the common femoral artery. Blood volume flow compromises the volume of blood crossing a single point in the common femoral artery, whereas time adjusted mean velocity is the rate of change of blood flow at this point. These assessments will be undertaken prior to application of the AirGlove device, and just prior to device removal at 30 minutes. Further haemodynamic assessments will be undertaken 10 minutes, 20 minutes, and 30 minutes post device removal. This will be assessed in this manner during each participant visit.
Measured: Participants in phases 1b and 1c will be measured at baseline and at a 12-week follow up visit. Participants in phase 1c will additionally be measured at visits at 3 and 6 weeks.
Change in ankle brachial pressure index and toe pressure index.
ABPI measurements will also be undertaken at the same timepoints both pre and post device removal. These assessments will be undertaken prior to application of the AirGlove device, and just prior to device removal at 30 minutes. Further haemodynamic assessments will be undertaken 10 minutes, 20 minutes, and 30 minutes post device removal.
Measured: Participants in phases 1b and 1c will be measured at baseline and at a 12-week follow up visit. Participants in phase 1c will additionally be measured at visits at 3 and 6 weeks.
EQ-5D-5L Questionnaire score
Participants in phases 1b and 1c will complete the EQ-5D-5L questionnaire to assess quality of life.
Measured: Participants in phases 1b and 1c will be measured at baseline and at a 12-week follow up visit. Participants in phase 1c will additionally be measured at visits at 3 and 6 weeks.
Intermittent Claudication Questionnaire score
Participants in phases 1b and 1c will complete the Intermittent Claudication Questionnaire to assess quality of life.
Measured: Participants in phases 1b and 1c will be measured at baseline and at a 12-week follow up visit. Participants in phase 1c will additionally be measured at visits at 3 and 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Why it stopped: Abandoned as the team couldn't get the design right for the product to work to be able to use it for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All cohorts of study will receive heat therapy from AirGlove device. Patient cohorts will undergo 12 weeks of heat therapy. Healthy control cohort will only receive a single session of heat therapy.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Stather, Mr, Principal investigator, Norfolk and Norwich University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186505
- Sponsor's protocol ID
- 304872 (42-03-21)
- Acronym
- HEATPAD
- Status last verified
- Jun 2026
- First submitted
- 5 Nov 2021
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Therapy for Peripheral Arterial Disease (HEATPAD)
- ClinicalTrials.gov ID
- NCT06186505
- Acronym / sponsor ID
- HEATPAD / 304872 (42-03-21)
- Keywords
- Healthy volunteers, AirGlove, Heat therapy, Walking distance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Abandoned as the team couldn't get the design right for the product to work to be able to use it for the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 treated early the blood supply can be improved. Currently patients are advised to exercise to improve their blood supply, however not all patients can do this. Recent work has shown that heat treatment could have a benefit in these patients to help improve walking distance and lower the risk of amputation. The studies so far have been limited to a one-off treatment, typically to the whole body rather than the affected leg. This study aims to use a device to warm the lower leg for a set amount of timeper day. The research team will look at the improvement in their walking distance and blood supply to the leg over a 12 week period.
The first phase of this study will be in healthy volunteers. They will undergo the trial protocol in a single session to assess acceptability of the trial protocol and identify potential barriers.
All patients invited into this study will be given the heat therapy device called AirGlove. This slides over the lower leg like a large sock, and hot air circulates within the sock itself. The research team will teach the patient how to use the device and they will then take it home for 12 weeks. At the start and end of the study patients will undergo tests to assess their walking distance, quality of life, pain, and to assess how much blood is getting down their leg.
This study will look at the role of heat therapy as an alternative to help improve their walking, potentially reducing the need for surgery, and saving legs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All cohorts of study will receive heat therapy from AirGlove device. Patient cohorts will undergo 12 weeks of heat therapy. Healthy control cohort will only receive a single session of heat therapy.
| Arm | Type | Receives |
|---|---|---|
| Phase 1a | Experimental | Device: AirGlovePhase 1a will be undertaken in 10 healthy volunteers to assess the effects of the AirGlove device on lower limb arterial flow, tissue perfusion, and product usability following a single session. Measurements will be taken just prior to device application, and then again at the time of device removal. |
| Phase 1b | Experimental | Device: AirGlovePhase 1b will be undertaken in 20 PAD patients 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. Measurements will be taken just prior to device application, and then again at the time of device removal at the start of the trial, and again at week 12 (in line with the recommended duration of SET). |
| Phase 1c | Experimental | Device: AirGlovePhase 1c will be undertaken in 10 PAD patients 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AirGloveAlso: GB001AirGlove 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. | Device | Phase 1a, Phase 1b, Phase 1c |
Primary outcome
Change in walking distance.
Time frame: Participants in phases 1b and 1c will be measured at baseline and at a 12-week follow up visit. Participants in phase 1c will additionally have their walking distance measured at visits at 3 and 6 weeks.
Participants in phase 1b and 1c will undergo a 6-minute walk test to measure the initial claudication distance and maximum claudication distance.
5 secondary outcomes
Change in tissue perfusion.
Time frame: Participants in phases 1b and 1c will be measured at baseline and at a 12-week follow up visit. Participants in phase 1c will additionally be measured at visits at 3 and 6 weeks.
Change in arterial blood flow.
Time frame: Participants in phases 1b and 1c will be measured at baseline and at a 12-week follow up visit. Participants in phase 1c will additionally be measured at visits at 3 and 6 weeks.
Change in ankle brachial pressure index and toe pressure index.
Time frame: Participants in phases 1b and 1c will be measured at baseline and at a 12-week follow up visit. Participants in phase 1c will additionally be measured at visits at 3 and 6 weeks.
EQ-5D-5L Questionnaire score
Time frame: Participants in phases 1b and 1c will be measured at baseline and at a 12-week follow up visit. Participants in phase 1c will additionally be measured at visits at 3 and 6 weeks.
Intermittent Claudication Questionnaire score
Time frame: Participants in phases 1b and 1c will be measured at baseline and at a 12-week follow up visit. Participants in phase 1c will additionally be measured at visits at 3 and 6 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Stather, Mr principal investigator
Norfolk and Norwich University Hospitals NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing AirGlove in people with Peripheral Arterial Disease and Intermittent Claudication, run by Norfolk and Norwich University Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in walking distance. (time frame: Participants in phases 1b and 1c will be measured at baseline and at a 12-week follow up visit. Participants in phase 1c will additionally have their walking distance measured at visits at 3 and 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.