Acute Effects of Leg Heating on Skeletal Muscle Blood Flow

Peripheral Arterial Disease Clinical Trial

Official title:

Acute Effects of Leg Heating on Skeletal Muscle Blood Flow in Patients With Symptomatic Peripheral Artery Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03763357
• Other study ID #: 1809400414
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cilostazol is the only effective medication available to treat walking pain (intermittent claudication) and it has multiple side effects. Overall improvement in walking performance in patients who use cilostazol is small. Endovascular and surgical interventions are effective alternatives for patients who don't respond to medical therapy, however, these procedures are costly and only applicable to patients with certain lesions types and carry a high risk of restenosis.

Heat therapy (HT) is an emerging non-invasive approach that has been shown to enhance vascular function of the leg in old individuals. The objective of this study is to test the hypothesis that a single session of heat therapy will increase local muscle tissue blood flow in the calf of patients with PAD as assessed by PET/CT imaging of generator-based 62Cu-ETS.

Subjects who have met inclusion criteria will volunteer for a single experimental visit. Participants will wear the water circulating pants and asked to rest supine for 30 minutes inside the scanner. Water at 43 degrees C will be perfused through the pants for 90 minutes with the goal to increase skin temperature in the calf to 39 degrees C. IV injections of 62Cu-ETS and subsequent perfusion imaging will be performed at the end of the 30 minute baseline period, after 45 minutes of heat therapy and at the end of the intervention (90 minutes). Due to the short half life of 62Cu, radioactivity from the prior administrations will not interfere with acquisition of a subsequent PET scan at this timing interval.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Men and women with a stable symptomatic claudication for >/= 6 months

• Ankle brachial index < 0.9

Exclusion Criteria:

• 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

• Claustrophobia/unable to tolerate PET/CT scanning

• Women of child-bearing age

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Heat Therapy (HT)
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Purdue University, Roseguini, Bruno, PhD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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