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Behavioural Intervention
Leg Heat Therapy for Peripheral Arterial Disease
Phase 3
Recruiting
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women older than 60 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3-month follow-up
Awards & highlights
Study Summary
This trial will evaluate the effects of leg heat therapy on lower-extremity functioning and quality of life in patients with PAD. 106 patients will be randomized to either leg HT or a sham intervention. Outcomes will be monitored for 12 weeks.
Who is the study for?
This trial is for men and women over 60 with lower-extremity peripheral artery disease (PAD), evidenced by a low ankle-brachial index. It's not for those with critical limb ischemia, other conditions limiting exercise tolerance, recent leg surgeries, use of walking aids besides a cane, severe kidney disease or obesity, inability to wear water-circulating trousers, certain mental impairments or thermal sensation issues in the legs.Check my eligibility
What is being tested?
The study tests if home-based leg heat therapy improves walking ability and quality of life in PAD patients compared to a sham control. Participants are randomly assigned to either real heat treatment or fake (sham) intervention and followed up after 12 weeks to measure changes in walk distance and various health scores.See study design
What are the potential side effects?
Potential side effects may include discomfort from the heat application or skin irritation under the water-circulating trousers used for therapy. Since it's non-invasive, serious side effects are unlikely but monitoring will occur for any unexpected reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 60 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 6-minute walk distance
Secondary outcome measures
Change in Short Physical Performance Battery (SPPB) score
Change in Short-Form (SF)-36 Questionnaire score
Change in Walking Impairment Questionnaire (WIQ) score
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Heat therapyExperimental Treatment1 Intervention
Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 42ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.
Group II: Sham ControlActive Control1 Intervention
Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 33ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
993 Previous Clinical Trials
1,095,177 Total Patients Enrolled
6 Trials studying Peripheral Arterial Disease
176 Patients Enrolled for Peripheral Arterial Disease
Purdue UniversityOTHER
227 Previous Clinical Trials
72,638 Total Patients Enrolled
2 Trials studying Peripheral Arterial Disease
7 Patients Enrolled for Peripheral Arterial Disease
National Institute on Aging (NIA)NIH
1,694 Previous Clinical Trials
28,027,219 Total Patients Enrolled
20 Trials studying Peripheral Arterial Disease
16,489 Patients Enrolled for Peripheral Arterial Disease
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a foot or leg amputation.I have severe leg pain at rest or wounds that won't heal due to poor blood flow.I use a walking aid that is not a cane.My leg circulation test shows poor blood flow.My kidney function is severely reduced.I can't have an MRI due to certain medical devices or conditions.My BMI is 35 or higher.I cannot fit into water-circulating trousers.Your Mini-Mental Status Examination score is less than 23.I am older than 60 years.You are not able to exercise because of health issues other than leg pain, like heart problems, arthritis, or severe lung disease.I had surgery on my legs or for bone issues in the last 3 months.You have trouble feeling hot or cold in your leg.My cancer is currently active.
Research Study Groups:
This trial has the following groups:- Group 1: Heat therapy
- Group 2: Sham Control
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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