Heat Therapy for Peripheral Arterial Disease (HEATPAD)

NCT06186505 | Not Yet Recruiting

• 1 other identifier: 304872 (42-03-21)
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Critical Limb Ischemia

Keywords

Healthy volunteers; AirGlove; Heat therapy; Walking distance

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  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 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 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.

Study Arms (3)

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.

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).

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.

Device: AirGlove

Interventions

AirGlove DEVICE

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.

Also known as: GB001

Phase 1a; Phase 1b; Phase 1c

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or over
• ABPI within normal range (0.9 - 1.2)
• Negative Edinburgh Claudication Questionnaire
• Capacity to provide informed consent
• Aged 60 or over
• ABPI \<0.9
• Positive Edinburgh Claudication Questionnaire

You may not qualify if:

• 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

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead
• GreenCross Medico Limited: collaborator

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Chronic Limb-Threatening Ischemia; Hyperthermia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes; Ischemia; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Philip Stather, Mr

  Norfolk and Norwich University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Dawson

CONTACT

01603 647882; julie.dawson@nnuh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: By the nature of the study treatments used within this study, blinding of the participants and clinicians is not possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: January 2, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share