Intermittent ClaudicationPhase 2NCT01007604
Treatment of Claudication With a Peristaltic Pulse Pneumatic Device
A Phase 2 study testing Peristaltic pulse PCD and Exercise and lifestyle counseling in people with Intermittent Claudication, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of a non-invasive peristaltic pulse pneumatic device (PCD) in the treatment of intermittent claudication in patients having documented peripheral arterial disease (PAD). The pneumatic device to be studied is FDA approved for the treatment of venous disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- Peristaltic pulse PCD and Exercise and lifestyle counseling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Mar 2011
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consistent claudication symptoms for at least 6 months
- ABIs at rest as follows: 0.5>ABI<0.8 minimally on one leg
Who cannot join
- Refuses to consent
- Unlikely to be compliant with protocol
- Unable to perform treadmill test
- Current use of Cilostazol (Pletal) or Pentoxyphylline (Trental)
- Lower extremity surgery or endovascular procedure within the last 3 months
- Currently has a non-healing wound on either leg
Show all 13Show fewer
- DVT in the past 3 months
- Unstable hypertension, angina, uncontrolled glucose levels
- Participating in a supervised exercise regimen
- Claudication medications regime changed within the last 3 months
- Diagnosis of Raynaud's Disease
- Requires a custom fabricated boot appliance
- Single limb amputees meeting inclusion criteria may participate in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
White River Junction VAMC
White River Junction, Vermont, 05009
Sharon R Besso, MS, ARNP, 802-295-9363 ext. 6390, sharon.besso@va.gov
Joseph P Duggan, DPM, 802-295-9363 ext. 5289, joseph.duggan@va.gov
About this study
Official title: Efficacy Study of a Peristaltic Pulse Pneumatic Device in the Treatment of Claudication
The purpose of this study is to evaluate the efficacy of a non-invasive peristaltic pulse pneumatic device (PCD) in the treatment of intermittent claudication in patients having documented peripheral arterial disease (PAD). The pneumatic device to be studied is FDA approved for the treatment of venous disease. While anecdotal evidence exists supporting a decrease in claudication symptoms, there are no previously published data on studies employing this compression device in the treatment of arterial disease. The investigators' primary hypothesis is that patients randomized to the intervention arm of the trial will experience an increase in mean walking ability as compared to the group receiving medical standard of care.
Read the detailed description
Peripheral arterial disease (PAD) is a common disorder, affecting 12% of adults older than 50 years of age. Approximately one third of these patients experience intermittent claudication, defined as pain in the thigh or calf muscles during walking and that resolves with rest. Lower extremity pain is often severe enough to significantly limit ambulation, forcing many patients to seek medical care. Current treatments include two FDA-approved medications, supervised walking programs, arterial angioplasty and/or stent placement, and open arterial bypass surgery. The problem is that noninvasive treatments are oftentimes ineffective, while invasive treatments are effective but expensive.
A non-invasive lower extremity treatment that has shown success in treating lymphedema and venous insufficiency will be studied during this protocol to assess its effects on claudication symptoms. Half of the participants in this prospective, single-center randomized controlled trial will be treated with a pneumatic compression device in a home treatment program, while half will receive standard medical therapy. If effective, potential benefits are high, providing relief of personal disability and avoidance of costly surgical intervention.
- Conditions
- Intermittent Claudication
- Being tested
- Peristaltic pulse PCD, Exercise and lifestyle counseling
- Keywords
- claudication, pneumatic compression device
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peristaltic pulse PCDDevice
Also called NormaTec PCD, Exercise and lifestyle counselling
Daily use for two hours
Exercise and lifestyle counselingOther
Also called Ambulatory exercise, Smoking cessation counseling
Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and lifestyle counselling | Active comparator | Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation. Receives: Other: Exercise and lifestyle counseling |
| PCD with peristaltic pulse waveform | Experimental | Daily use for two hours Receives: Device: Peristaltic pulse PCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak walking time (in seconds) during a graded-protocol treadmill test
Measured: initial; 3 months; 6 months
Secondary outcomes (4)
Claudication onset time (in seconds) during a graded-protocol treadmill test
Measured: initial; 3 months; six months
Walking Impairment Questionnaire, including pain subscale, speed subscale and stair climbing subscale
Measured: initial; 3 months; 6 months
Ankle-Brachial Index (ABI)
Measured: initial; 3 months; 6 months
Integumentary changes as evaluated by photographs of lower extremity hair pattern and great toenail growth
Measured: initial; 3 months; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- White River Junction Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- NormaTec Industries LP
- Investigators
- Sharon R Besso, MS, ARNP, Principal investigator, White River Junction Veterans Affairs Medical CenterJoseph P Duggan, DPM, Principal investigator, White River Junction Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007604
- Sponsor's protocol ID
- 21975
- Status last verified
- Nov 2009
- First submitted
- 3 Nov 2009
- Last updated
- 4 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of a Peristaltic Pulse Pneumatic Device in the Treatment of Claudication
- ClinicalTrials.gov ID
- NCT01007604
- Acronym / sponsor ID
- 21975
- Conditions
- Intermittent Claudication
- Keywords
- claudication, pneumatic compression device
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Collaborators
- NormaTec Industries LP
- Study start
- Nov 2009
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 4 Nov 2009 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy of a non-invasive peristaltic pulse pneumatic device (PCD) in the treatment of intermittent claudication in patients having documented peripheral arterial disease (PAD). The pneumatic device to be studied is FDA approved for the treatment of venous disease. While anecdotal evidence exists supporting a decrease in claudication symptoms, there are no previously published data on studies employing this compression device in the treatment of arterial disease. The investigators' primary hypothesis is that patients randomized to the intervention arm of the trial will experience an increase in mean walking ability as compared to the group receiving medical standard of care.
Detailed description
Peripheral arterial disease (PAD) is a common disorder, affecting 12% of adults older than 50 years of age. Approximately one third of these patients experience intermittent claudication, defined as pain in the thigh or calf muscles during walking and that resolves with rest. Lower extremity pain is often severe enough to significantly limit ambulation, forcing many patients to seek medical care. Current treatments include two FDA-approved medications, supervised walking programs, arterial angioplasty and/or stent placement, and open arterial bypass surgery. The problem is that noninvasive treatments are oftentimes ineffective, while invasive treatments are effective but expensive.
A non-invasive lower extremity treatment that has shown success in treating lymphedema and venous insufficiency will be studied during this protocol to assess its effects on claudication symptoms. Half of the participants in this prospective, single-center randomized controlled trial will be treated with a pneumatic compression device in a home treatment program, while half will receive standard medical therapy. If effective, potential benefits are high, providing relief of personal disability and avoidance of costly surgical intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and lifestyle counselling | Active comparator | Other: Exercise and lifestyle counselingPatients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation. |
| PCD with peristaltic pulse waveform | Experimental | Device: Peristaltic pulse PCDDaily use for two hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consistent claudication symptoms for at least 6 months
- ABIs at rest as follows: 0.5>ABI<0.8 minimally on one leg
Key exclusion criteria (13 listed)
- Refuses to consent
- Unlikely to be compliant with protocol
- Unable to perform treadmill test
- Current use of Cilostazol (Pletal) or Pentoxyphylline (Trental)
- Lower extremity surgery or endovascular procedure within the last 3 months
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 |
|---|---|---|
| Peristaltic pulse PCDAlso: NormaTec PCD, Exercise and lifestyle counsellingDaily use for two hours | Device | PCD with peristaltic pulse waveform |
| Exercise and lifestyle counselingAlso: Ambulatory exercise, Smoking cessation counselingPatients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation. | Other | Exercise and lifestyle counselling |
Primary outcome
Peak walking time (in seconds) during a graded-protocol treadmill test
Time frame: initial; 3 months; 6 months
4 secondary outcomes
Claudication onset time (in seconds) during a graded-protocol treadmill test
Time frame: initial; 3 months; six months
Walking Impairment Questionnaire, including pain subscale, speed subscale and stair climbing subscale
Time frame: initial; 3 months; 6 months
Ankle-Brachial Index (ABI)
Time frame: initial; 3 months; 6 months
Integumentary changes as evaluated by photographs of lower extremity hair pattern and great toenail growth
Time frame: initial; 3 months; 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2009.
Related trials for Intermittent Claudication
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
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.
Sharon R Besso, MS, ARNP principal investigator
White River Junction Veterans Affairs Medical Center
Joseph P Duggan, DPM principal investigator
White River Junction Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peristaltic pulse PCD and Exercise and lifestyle counseling in people with Intermittent Claudication, run by White River Junction Veterans Affairs Medical Center 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 2 inclusion and 13 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 4 Nov 2009. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sharon R Besso, MS, ARNP (802-295-9363 ext. 6390, sharon.besso@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak walking time (in seconds) during a graded-protocol treadmill test (time frame: initial; 3 months; 6 months). 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 4 Nov 2009.