Peripheral Arterial DiseaseNCT03462472
Effect of Lower Leg Heating and Transcutaneous Electrical Nerve Stimulation on Exercise Capacity in Patients With PAD
A study testing Lower leg heating and Lower leg transcutaneous electrical nerve stimulation (TENS) in people with Peripheral Arterial Disease, run by Salisbury University at 1 site in United States.
Trial summary
Peripheral arterial disease (PAD) is characterized by poor circulation in the lower extremities that often provokes claudication (leg pain, numbness, and heaviness) with physical exertion. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Lower leg heating and Lower leg transcutaneous electrical nerve stimulation (TENS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intermittent claudication (Fontaine Stage II)
- Resting ankle-brachial index (ABI) < 0.90
- Ability to walk > 60 meters in six minutes
Who cannot join
- Body mass index (BMI) > 35 kg/m2
- Severe exercise limitations (more than PAD) due to co-morbidity
- Taking illegal/recreational drugs
- Uncontrolled hypertension (>180/100 mmHg)
- Severe peripheral neuropathy
- Foot ulcers
- Gangrene
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Salisbury University
Salisbury, Maryland, 21801
Tom Pellinger, Ph.D., 410-677-0144, tkpellinger@salisbury.edu
About this study
Official title: The Acute Effects of Leg Heating and Transcutaneous Electrical Nerve Stimulation on Leg Blood Flow and Functional Capacity in Those With Peripheral Arterial Disease
Peripheral arterial disease (PAD) is characterized by poor circulation in the lower extremities that often provokes claudication (leg pain, numbness, and heaviness) with physical exertion. The aim of this research protocol is to determine the effect of two non-invasive treatment modalities on leg blood flow and exercise capacity in those with PAD. Specifically, we are measuring popliteal artery blood flow (Doppler ultrasound), toe oxygen saturation, ankle-brachial index (ABI), and 6-minute walking distance (6MWD) in men and women who have intermittent claudication (Fontaine Stage II; Rutherford Category 1-2) in response to 15 or 45 minutes of lower limb heating and transcutaneous electrical nerve stimulation (TENS).
- Conditions
- Peripheral Arterial Disease
- Being tested
- Lower leg heating, Lower leg transcutaneous electrical nerve stimulation (TENS)
- 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.
Lower leg heatingBehavioural
Immersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius
Lower leg transcutaneous electrical nerve stimulation (TENS)Behavioural
Bilateral lower leg transcutaneous electrical nerve stimulation (TENS) using burst mode at a 3Hz burst rate, 100Hz frequency, and 250 µs pulse duration, sufficient to evoke skeletal muscle contraction
| Study group | Role | What they receive |
|---|---|---|
| 15 minute lower leg heating | Experimental | Not described Receives: Behavioral: Lower leg heating |
| 45 minute lower leg heating | Experimental | Not described Receives: Behavioral: Lower leg heating |
| Control | No intervention | Not described |
| 15 minute lower leg TENS | Experimental | Not described Receives: Behavioral: Lower leg transcutaneous electrical nerve stimulation (TENS) |
| 45 minute lower leg TENS | Experimental | Not described Receives: Behavioral: Lower leg transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked during six-minute walk test
Distance walked during a self-paced six-minute walk
Measured: 35 minutes post-intervention/control
Secondary outcomes (4)
Popliteal artery blood flow
Unilateral popliteal blood flow measured via Doppler ultrasound
Measured: Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control
Time/distance to claudication during six-minute walk
Subjects give subjective ratings of claudication onset, if applicable, during six-minute walk test
Measured: 35 minutes following each intervention and control period
Ankle brachial index (ABI)
Systolic blood pressures (SBP) are measured in the brachial arteries of both arms and in the posterior tibial and dorsalis pedis arteries of both ankles using a hand-held Doppler ultrasound probe and a sphygmomanometer
Measured: Pre-intervention baseline and 20 minutes post-intervention/control
Toe oxygen saturation
A pulse oximeter is used to measure toe oxygen saturation in the big toe of each of the subject's feet
Measured: Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start15 Nov 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salisbury University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas K. Pellinger, Ph.D., Principal investigator, Salisbury University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462472
- Sponsor's protocol ID
- 11112015-2
- Status last verified
- Mar 2018
- First submitted
- 13 Feb 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Leg Heating and Transcutaneous Electrical Nerve Stimulation on Leg Blood Flow and Functional Capacity in Those With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT03462472
- Acronym / sponsor ID
- 11112015-2
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Salisbury UniversityUniversity, hospital or other
- Study start
- 15 Nov 2015 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peripheral arterial disease (PAD) is characterized by poor circulation in the lower extremities that often provokes claudication (leg pain, numbness, and heaviness) with physical exertion. The aim of this research protocol is to determine the effect of two non-invasive treatment modalities on leg blood flow and exercise capacity in those with PAD. Specifically, we are measuring popliteal artery blood flow (Doppler ultrasound), toe oxygen saturation, ankle-brachial index (ABI), and 6-minute walking distance (6MWD) in men and women who have intermittent claudication (Fontaine Stage II; Rutherford Category 1-2) in response to 15 or 45 minutes of lower limb heating and transcutaneous electrical nerve stimulation (TENS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 15 minute lower leg heating | Experimental | Behavioral: Lower leg heating |
| 45 minute lower leg heating | Experimental | Behavioral: Lower leg heating |
| Control | No intervention | – |
| 15 minute lower leg TENS | Experimental | Behavioral: Lower leg transcutaneous electrical nerve stimulation (TENS) |
| 45 minute lower leg TENS | Experimental | Behavioral: Lower leg transcutaneous electrical nerve stimulation (TENS) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intermittent claudication (Fontaine Stage II)
- Resting ankle-brachial index (ABI) < 0.90
- Ability to walk > 60 meters in six minutes
Key exclusion criteria (8 listed)
- Body mass index (BMI) > 35 kg/m2
- Severe exercise limitations (more than PAD) due to co-morbidity
- Taking illegal/recreational drugs
- Uncontrolled hypertension (>180/100 mmHg)
- Severe peripheral neuropathy
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 |
|---|---|---|
| Lower leg heatingImmersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius | Behavioural | 15 minute lower leg heating, 45 minute lower leg heating |
| Lower leg transcutaneous electrical nerve stimulation (TENS)Bilateral lower leg transcutaneous electrical nerve stimulation (TENS) using burst mode at a 3Hz burst rate, 100Hz frequency, and 250 µs pulse duration, sufficient to evoke skeletal muscle contraction | Behavioural | 15 minute lower leg TENS, 45 minute lower leg TENS |
Primary outcome
Distance walked during six-minute walk test
Time frame: 35 minutes post-intervention/control
Distance walked during a self-paced six-minute walk
4 secondary outcomes
Popliteal artery blood flow
Time frame: Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control
Time/distance to claudication during six-minute walk
Time frame: 35 minutes following each intervention and control period
Ankle brachial index (ABI)
Time frame: Pre-intervention baseline and 20 minutes post-intervention/control
Toe oxygen saturation
Time frame: Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Thomas K. Pellinger, Ph.D. principal investigator
Salisbury University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower leg heating and Lower leg transcutaneous electrical nerve stimulation (TENS) in people with Peripheral Arterial Disease, run by Salisbury University at 1 site 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Pellinger, Ph.D. (410-677-0144, tkpellinger@salisbury.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance walked during six-minute walk test (time frame: 35 minutes post-intervention/control). 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 12 Mar 2018.