Home-based Leg Heat Therapy

NCT03763331 | Completed Results DMC FDA Device

• 1 other identifier: 1801755556
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the benefits of participating for 8 weeks in a home-based daily treatment with heat therapy (HT) or a thermoneutral control intervention, as assessed by vascular function, walking tolerance and quality of life.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Change in 6-min Walk Distance

  Change in 6-min walk distance from baseline to the 8-week follow-up

  8 weeks

Secondary Outcomes (5)

• Change in Treadmill Peak Walking Time

  8 weeks

• Change in Peak Calf Blood Flow

  8 weeks

• Change in Leg Cutaneous Vascular Conductance

  8 weeks

• Change in the Vascular Quality of Life Questionnaire-6 Score

  8 weeks

• Change in the Short Form 36 Physical Functioning Score

  8 weeks

Study Arms (2)

Sham treatment

SHAM COMPARATOR

Participants were dressed in water-circulating trousers that are connected to a pump. Water at 91.4 degrees F was circulated through the pants for 90 minutes daily for 8 weeks..

Device: Control/Sham Treatment

Heat Therapy

ACTIVE COMPARATOR

Participants were dressed in water-circulating trousers that are connected to a pump. Water at 110 degrees F will be circulated through the pants for 90 minutes daily for 8 weeks.

Device: Heat Therapy

Interventions

Control/Sham Treatment DEVICE

Thermoneutral water will be circulated through water-circulating trousers to maintain skin temperature at baselines levels daily for 90 minutes for 8 weeks.

Sham treatment

Heat Therapy DEVICE

Water at 110 degrees F will be circulated through water-circulating trousers daily for 90 minutes for 8 weeks.

Heat Therapy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with a stable symptomatic PAD for ≥6 months
• Ankle brachial index \<0.9 in at least one leg
• Age between 40 and 80 years

You may not qualify if:

• Uncontrolled Diabetes (HbA1C \> 8.5 measured within 3 months prior to date of consent)
• Wheelchair bound
• Use of a walking aid (i.e. cane, crutches, walker, motorized chair)
• Critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or tissue loss
• Impaired thermal sensation in the legs
• Exercise-limiting comorbidity
• Chronic Heart Failure stages C and stage D (Stage C: structural heart disease is present and symptoms have occurred; Stage D: presence of advanced heart disease with continued heart failure symptoms requiring aggressive medical therapy)
• Morbid obesity BMI \> 35 or unable to fit into water-circulating pants
• Open wounds or ulcers on the extremity
• Prior amputation
• Lower extremity revascularization, major orthopedic surgery, cardiovascular event, or coronary revascularization in the previous three months
• Planned revascularization or major surgery during the next six months
• Plans to change medical therapy during the duration of the study
• Active treatment for cancer
• Chronic kidney disease (eGFR \<30 by MDRD or Mayo or Cockcroft-Gault formula).

Sponsors & Collaborators

• Indiana University: lead
• Roseguini, Bruno, PhD: collaborator

Study Sites (1)

IU Heath Methodist

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Results Point of Contact

• Title: Dr. Bruno Roseguini
• Organization: Purdue University

brosegui@purdue.edu

7654906284

Study Officials

• R Motaganahalli

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were informed that there were two different categories of heat therapy, "low heat" and "high heat," and that both might be beneficial for claudication symptoms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients were randomized (blocked and stratified by sex) using assignments generated from PROC PLAN in SAS Version 9.4 by the study statistician into one of two groups: those receiving leg heat therapy or those receiving the sham treatment.

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: December 4, 2018
• Study Start: January 14, 2019
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2023-02

Locations

US (1)