Peripheral Artery DiseaseNCT02770547
Leg Thermotherapy for Intermittent Claudication
A study testing Low Heat Thermotherapy and High Heat Thermotherapy in people with Peripheral Artery Disease, run by Indiana University at 2 sites in United States.
Trial summary
This study proposes to evaluate the potential of leg thermotherapy as a non-pharmacological intervention that could improve the mobility and exercise tolerance of patients with intermittent claudication. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Low Heat Thermotherapy and High Heat Thermotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 May 2016to 14 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with a stable symptomatic claudication for ≥6 months
- Ankle brachial index <0.9
Who cannot join
- Uncontrolled Diabetes (HbA1C > 8.5 measured within 3 months prior to date of consent)
- Heart Failure
- Chronic Obstructive Pulmonary Disease
- Critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or tissue loss
- Prior amputation
- Exercise-limiting comorbidity (i.e., angina, chronic lung disease, or arthritis)
Show all 26Show fewer
- Recent (<3 months) infrainguinal revascularization (surgery or endovascular revascularization) or revascularization planned during study period.
- Plans to change medical therapy during the duration of the study
- Active cancer
- Chronic kidney disease (eGFR <30 by Modification of Diet in Renal Disease or Mayo or Cockcroft-Gault formula).
- HIV positive, active hepatitis B virus (HBV) or hepatitis C virus (HCV) disease.
- Presence of any clinical condition that in the opinion of the principal investigator makes the patient not suitable to participate in the trial.
- Peripheral neuropathy, numbness, or paresthesia in the legs.
- Morbid obesity BMI > 35.
- Open wounds or ulcers on the extremity.
- MRI Exclusions:
- Cardiac pacemaker
- Implanted cardiac defibrillator
- Aneurysm clips
- Carotid artery vascular clamp
- Neurostimulator
- Insulin or infusion pump
- Implanted drug infusion device
- Bone growth/fusion stimulator
- Cochlear, otologic, or ear implant
- History of claustrophobia or who are unable to lie flat or who do not fit inside the bore of the scanner
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, 46202
About this study
This study proposes to evaluate the potential of leg thermotherapy as a non-pharmacological intervention that could improve the mobility and exercise tolerance of patients with intermittent claudication. Thermotherapy is a simple, easily applicable therapy that enhances exercise tolerance in patients with chronic heart failure by improving peripheral vascular endothelial function.
Read the detailed description
Peripheral arterial disease is characterized by atherosclerotic obstruction of the arteries in the lower extremities and affects approximately 10% of individuals older than 65 years. The most common clinical presentation of peripheral arterial disease is intermittent claudication, defined as leg pain caused by insufficient blood flow during walking. Individuals with intermittent claudication have severe exercise intolerance and markedly reduced levels of daily ambulatory activity. It is estimated that up to 40 million people worldwide suffer from intermittent claudication. Despite the increasing prevalence of this condition, few medical therapies improve mobility and exercise tolerance in these patients. An urgent need remains for the development of novel, non-invasive strategies that are more widely accessible and eliminate the need for supervision and frequent traveling to a clinical facility. The study proposes to evaluate the potential of leg thermotherapy as a non-pharmacological intervention that could improve the mobility and exercise tolerance of patients with intermittent claudication.
Subjects will complete baseline assessments for eligibility and ability to do study, including medical history, quality of life assessment, ankle-brachial measurement, leg MRI, venous blood draw, assessment of vascular function, and 6-minute walk test. Treatment consists of 3 treatment sessions per week for six consecutive weeks. Subjects will be randomized to low-heat therapy or high-heat therapy. Subjects will wear water-circulating pants through which the heat therapy will be administered during the treatment sessions. Outcome measurements (same as baseline assessments) will be repeated after 9 treatment sessions and after 18 treatment sessions (at the end of the treatment period).
- Conditions
- Peripheral Artery Disease
- Being tested
- Low Heat Thermotherapy, High Heat Thermotherapy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Heat ThermotherapyDevice
Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
High Heat ThermotherapyDevice
Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
| Study group | Role | What they receive |
|---|---|---|
| Low Heat Thermotherapy | Active comparator | Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg. Receives: Device: Low Heat Thermotherapy |
| High Heat Thermotherapy | Experimental | High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg. Receives: Device: High Heat Thermotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes
6-minutes walk test
Measured: Maximal walking distances on a 6mwt were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Blood Pressure
Participants have systolic, diastolic and mean blood pressure recording 14 times during baseline, week 3 and week 6 experimental sessions.
Measured: Average blood pressure taken every 5 minutes for 70 minutes was obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Circulating Levels of Endothelin-1 (pg/mL)
Blood draw
Measured: Serum endothelin-1 levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Circulating Total Nitrate Levels (mmol)
Blood Draw
Measured: Serum total nitrate levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Secondary outcomes (4)
Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s)
Phase contrast magnetic resonance imaging was performed on the leg that the patient indicated to have the most severe claudication. An inflation cuff was placed around the thigh and inflated to 75 mmHg above resting brachial systolic pressure for 5 minutes. After 5 minutes of inflation, the cuff was release and an additional 10 minutes of imaging took place.
Measured: Peak flows after post-occlusive reactive hyperemia were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Vascular Function Measured by Ankle-brachial Index - Calculated by Dividing Higher of Posterior Tibial or Dorsalis Pedis Blood Pressure (mmHg) by Higher of Right or Left Arm Systolic Blood Pressure (mmHg)
Ankle-brachial Index
Measured: Ankle-brachial index measures were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the Skin
Laser-Doppler flowmetry of skin included placement of two heating probes on the anterior portion of the lower leg. The participant sat in a semi-recumbent position for 70 minutes while the temperature of the probe progressed from 33C to 39C at minute 10 and then to 43C at minute 50. Cutaneous vascular conductance was calculated at the average red blood cell flux during the final 2 minutes of the 39C heating portion divided by the mean arterial pressure taken at that time.
Measured: Maximal cutaneous vascular conductance values after 40 minutes of localized heating were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
36-item Short Form Health Survey. All scales are scored 1-100, with 1 being the poorest rating and 100 being the most optimal.
Measured: SF-36 questionnaires were administered at weeks 3/6 and 6/6 of the study and compared to baseline values.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start30 May 2016
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Raghu Motaganahalli, Indiana University
- Investigators
- Bruno Tesini Roseguini, PhD, Study director, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770547
- Sponsor's protocol ID
- 1601589496
- Status last verified
- Jan 2020
- First submitted
- 5 May 2016
- Last updated
- 10 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leg Thermotherapy for Intermittent Claudication
- ClinicalTrials.gov ID
- NCT02770547
- Acronym / sponsor ID
- 1601589496
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 30 May 2016 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Posted 10 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes to evaluate the potential of leg thermotherapy as a non-pharmacological intervention that could improve the mobility and exercise tolerance of patients with intermittent claudication. Thermotherapy is a simple, easily applicable therapy that enhances exercise tolerance in patients with chronic heart failure by improving peripheral vascular endothelial function.
Detailed description
Peripheral arterial disease is characterized by atherosclerotic obstruction of the arteries in the lower extremities and affects approximately 10% of individuals older than 65 years. The most common clinical presentation of peripheral arterial disease is intermittent claudication, defined as leg pain caused by insufficient blood flow during walking. Individuals with intermittent claudication have severe exercise intolerance and markedly reduced levels of daily ambulatory activity. It is estimated that up to 40 million people worldwide suffer from intermittent claudication. Despite the increasing prevalence of this condition, few medical therapies improve mobility and exercise tolerance in these patients. An urgent need remains for the development of novel, non-invasive strategies that are more widely accessible and eliminate the need for supervision and frequent traveling to a clinical facility. The study proposes to evaluate the potential of leg thermotherapy as a non-pharmacological intervention that could improve the mobility and exercise tolerance of patients with intermittent claudication.
Subjects will complete baseline assessments for eligibility and ability to do study, including medical history, quality of life assessment, ankle-brachial measurement, leg MRI, venous blood draw, assessment of vascular function, and 6-minute walk test. Treatment consists of 3 treatment sessions per week for six consecutive weeks. Subjects will be randomized to low-heat therapy or high-heat therapy. Subjects will wear water-circulating pants through which the heat therapy will be administered during the treatment sessions. Outcome measurements (same as baseline assessments) will be repeated after 9 treatment sessions and after 18 treatment sessions (at the end of the treatment period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Heat Thermotherapy | Active comparator | Device: Low Heat ThermotherapyLow heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg. |
| High Heat Thermotherapy | Experimental | Device: High Heat ThermotherapyHigh heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women with a stable symptomatic claudication for ≥6 months
- Ankle brachial index <0.9
Key exclusion criteria (26 listed)
- Uncontrolled Diabetes (HbA1C > 8.5 measured within 3 months prior to date of consent)
- Heart Failure
- Chronic Obstructive Pulmonary Disease
- Critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or tissue loss
- Prior amputation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Heat ThermotherapySubject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg. | Device | Low Heat Thermotherapy |
| High Heat ThermotherapySubject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg. | Device | High Heat Thermotherapy |
Primary outcome
Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes
Time frame: Maximal walking distances on a 6mwt were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
6-minutes walk test
Blood Pressure
Time frame: Average blood pressure taken every 5 minutes for 70 minutes was obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Participants have systolic, diastolic and mean blood pressure recording 14 times during baseline, week 3 and week 6 experimental sessions.
Circulating Levels of Endothelin-1 (pg/mL)
Time frame: Serum endothelin-1 levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Blood draw
Circulating Total Nitrate Levels (mmol)
Time frame: Serum total nitrate levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Blood Draw
4 secondary outcomes
Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s)
Time frame: Peak flows after post-occlusive reactive hyperemia were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Vascular Function Measured by Ankle-brachial Index - Calculated by Dividing Higher of Posterior Tibial or Dorsalis Pedis Blood Pressure (mmHg) by Higher of Right or Left Arm Systolic Blood Pressure (mmHg)
Time frame: Ankle-brachial index measures were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the Skin
Time frame: Maximal cutaneous vascular conductance values after 40 minutes of localized heating were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Time frame: SF-36 questionnaires were administered at weeks 3/6 and 6/6 of the study and compared to baseline values.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Tesini Roseguini, PhD study director
Purdue University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Heat Thermotherapy and High Heat Thermotherapy in people with Peripheral Artery Disease, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes (time frame: Maximal walking distances on a 6mwt were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.