Acute Effects of Leg Heating on Skeletal Muscle Blood Flow

NCT03763357 | Withdrawn

• 1 other identifier: 1809400414
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to apply local heat to the legs, thighs and buttocks of patients with peripheral arterial disease and use PET/CT imaging with an injectable stable radiotracer to study direct measurement of blood flow in the legs pre and post heat treatment.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Change in calf blood flow

  Calf muscle perfusion rate (mL⋅min-1⋅g-1) will be obtained after administration of tracer 62Cu-ETS before, during and after exposure to heat therapy or a control intervention. Changes from in perfusion rate from baseline to 45 minutes and 90 minutes of heating or control will be measured.

  Blood flow measurements will be completed at baseline (0 minutes) and after 45 and 90 minutes of exposure to heat therapy or a control regimen

Study Arms (1)

Heat Therapy

EXPERIMENTAL

Subject will dress in water-circulating trousers that are connected to a Heat Therapy (HT) pump. Warm water (42-43 degrees C) will be perfused through the pants for 90 minutes.

Device: Heat Therapy (HT)

Interventions

Heat Therapy (HT) DEVICE

Water at 42-43 degrees C will be circulated through the water circulating trousers to obtain calf skin temperature 39 degrees C followed by PET/CT imaging of generator-based 62Cu-ETS.

Heat Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with a stable symptomatic claudication for \>/= 6 months
• Ankle brachial index \< 0.9

You may not qualify if:

• Uncontrolled diabetes
• Heart failure
• COPD
• Critical limb ischemia
• Prior amputation
• Exercise-limiting co-morbidity
• Recent (\< 3 months) intra-inguinal revascularization or planned in study period
• Plans to change medical therapy during duration of study
• Active cancer
• Chronic kidney disease (eGFR \< 30)
• HIV positive, active HBV or HCV disease
• Presence of an clinical condition that makes the patient not suitable to participate in the trial
• Peripheral neuropathy, numbness or paresthesia in the legs
• Morbid obesity BMI \> 36 or unable to fit into water-circulating pants
• Open wounds or ulcers on the extremity

Sponsors & Collaborators

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

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

Study Officials

• Raghu L Motaanahalli, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All of the subjects in this study will receive leg heat therapy.

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: December 4, 2018
• Study Start: July 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share