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Heat Therapy for Peripheral Arterial Disease (HEATPAD)

NCT06186505 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-01-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • GreenCross Medico Limited

    collaborator UNKNOWN

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Philip Stather, Mr · Norfolk and Norwich University Hospitals NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2028-10-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06186505 on ClinicalTrials.gov