Peripheral Arterial DiseasePhase 1NCT02384980

Saving Life and Limb: FES for the Elderly With PAD

A Phase 1 study testing FES (Gait MyoElectric Stimulator) in people with Peripheral Arterial Disease, run by MultiCare Health System Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will take the first step to improve public health for millions of Americans with Peripheral Arterial Disease who have extreme difficulty walking due to leg pain. The investigators will assess a proof of concept, home administered, functional electrical stimulation (FES) system to resolve pain, improve… Read more about this study

Who is it for?: Ages 50 to 85 years
Conditions the study is for: Peripheral Arterial Disease
What is being tested?: FES (Gait MyoElectric Stimulator)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Sep 2014to May 2016
Phase: Phase 1
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 50 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who:
Are ambulatory, community dwelling adults with evidence of PAD including ankle/brachial index ABI=0.4-0.9
Have symptom severity of Fontaine stage II-III
Have a score of 24 or higher on the Folstein Mini Mental test
Have visible muscle contraction of the plantar flexor (PF) and dorsiflexor (DF) muscles using FES

Who cannot join

Patients who:
Have an electronic implanted stimulator such as pacemaker, defibrillator, deep brain stimulator, spinal cord stimulator
Are pregnant
Cannot walk without a walker or require human assistance to walk,
Present with arthritis or neurological damage resulting in paresis or paralysis of the lower extremity
Have skin lesion(s) on the legs where the FES is placed

Trial locations and contacts

1 site in 1 country.

United States1 site

MultiCare Health System
Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: Saving Life and Limb: Functional Electrical Stimulation for the Elderly With Peripheral Artery Disease

Read the detailed description

This study will evaluate an innovative approach to reduce the debilitating symptoms of peripheral arterial disease (PAD) and ischemic pain during walking (intermittent claudication) by using a new Functional Electrical Stimulation (FES) system. The investigators hypothesize that combining the FES and walking one hour/day (FES+Walk) will significantly reduce pain during walking, improve locomotion, and enhance quality of life when compared to walking one hour/day (Walk) alone after 8 weeks of intervention.

Conditions: Peripheral Arterial Disease
Being tested: FES (Gait MyoElectric Stimulator)
Keywords: Intermittent Claudication, Functional Electrical Stimulation
Medical subject headings: Peripheral Arterial Disease, Intermittent Claudication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FES (Gait MyoElectric Stimulator)Device
Functional Electrical Stimulation (FES) will be tested in a group of peripheral arterial disease patients using the Gait MyoElectric Stimulator. The FES device will be applied to the calf and shin muscles on both of the patients legs.

Study groups in NCT02384980
Study group	Role	What they receive
Walk Group	No intervention	This group of patients are part of the walk group. They will be encouraged to walk and will receive standard care, defined as conservative (non-surgical) management of signs and symptoms, including prescriptive medications to improve circulation and manage pain, determined by their attending physician on a case by case basis.
FES + Walk Group	Experimental	This group of patients will participate in Functional Electrical Stimulation (FES) and exercise. This group will receive functional electrical stimulation as an intervention. The FES device will stimulate (activate) the calf and shin leg muscles of both legs while the patient is walking. This group will also receive standard care, defined as conservative (non-surgical) management of signs and symptoms, including prescriptive medications to improve circulation and manage pain, determined by their attending physician on a case by case basis. Receives: Device: FES (Gait MyoElectric Stimulator)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from initial assessment, baseline, end of intervention and final assessment using the Perceived Pain Intensity Scale
We will measure the changes in pain scores from baseline to end of intervention and end of post-intervention
Measured: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post-intervention)
Change from initial assessment, baseline, end of intervention and final assessment using the 6 Minute Walk Test
We will measure the changes in distance walked during the 6 minute walk test
Measured: Initial, baseline assessment, assessment at the end of 8 weeks intervention, and final assessment at 16 weeks (8 weeks post- intervention)
Change from initial assessment, baseline, end of intervention and final assessment using the Peripheral Artery Disease Quality of Life Questionnaire
We will record and measure the changes in questionnaire scores from baseline to end of intervention and end of post-intervention
Measured: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention)

Secondary outcomes (2)

Change from initial assessment, baseline, end of intervention and final assessment using the Timed-Up-and-Go test
We will measure the time (seconds) to complete the test from baseline to end of intervention and end of post-intervention
Measured: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention)
Change from initial assessment, baseline, end of intervention and final assessment using the Intermittent Claudication Questionnaire (ICQ)
We will record and measure the questionnaire score from baseline to end of intervention and end of post-intervention
Measured: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014May 2016

First posted10 Mar 2015 (estimated)
Study startSep 2014
Primary completionMar 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02384980
Sponsor's protocol ID: 14.12
Other IDs: 1R21AG048001-01
Status last verified: Aug 2016
First submitted: 10 Nov 2014
Last updated: 16 Aug 2016
Results posted: No
Data monitoring committee: Yes

Publications

Embrey DG, Alon G, Brandsma BA, Vladimir F, Silva A, Pflugeisen BM, Amoroso PJ. Functional electrical stimulation improves quality of life by reducing intermittent claudication. Int J Cardiol. 2017 Sep 15;243:454-459. doi: 10.1016/j.ijcard.2017.05.097. Epub 2017 Jun 2.
PubMed 28595744

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Saving Life and Limb: Functional Electrical Stimulation for the Elderly With Peripheral Artery Disease
ClinicalTrials.gov ID: NCT02384980
Acronym / sponsor ID: 14.12
Conditions: Peripheral Arterial Disease
Keywords: Intermittent Claudication, Functional Electrical Stimulation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: MultiCare Health System Research InstituteUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Sep 2014
Primary completion: Mar 2016 (actual)
Study completion: May 2016 (actual)
First posted: 10 Mar 2015 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Walk Group	No intervention	–This group of patients are part of the walk group. They will be encouraged to walk and will receive standard care, defined as conservative (non-surgical) management of signs and symptoms, including prescriptive medications to improve circulation and manage pain, determined by their attending physician on a case by case basis.
FES + Walk Group	Experimental	Device: FES (Gait MyoElectric Stimulator)This group of patients will participate in Functional Electrical Stimulation (FES) and exercise. This group will receive functional electrical stimulation as an intervention. The FES device will stimulate (activate) the calf and shin leg muscles of both legs while the patient is walking. This group will also receive standard care, defined as conservative (non-surgical) management of signs and symptoms, including prescriptive medications to improve circulation and manage pain, determined by their attending physician on a case by case basis.

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Are ambulatory, community dwelling adults with evidence of PAD including ankle/brachial index ABI=0.4-0.9
Have symptom severity of Fontaine stage II-III
Have a score of 24 or higher on the Folstein Mini Mental test
Have visible muscle contraction of the plantar flexor (PF) and dorsiflexor (DF) muscles using FES

Key exclusion criteria (6 listed)

Have an electronic implanted stimulator such as pacemaker, defibrillator, deep brain stimulator, spinal cord stimulator
Are pregnant
Cannot walk without a walker or require human assistance to walk,
Present with arthritis or neurological damage resulting in paresis or paralysis of the lower extremity
Have skin lesion(s) on the legs where the FES is placed

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
FES (Gait MyoElectric Stimulator)Functional Electrical Stimulation (FES) will be tested in a group of peripheral arterial disease patients using the Gait MyoElectric Stimulator. The FES device will be applied to the calf and shin muscles on both of the patients legs.	Device	FES + Walk Group

Primary outcome

Change from initial assessment, baseline, end of intervention and final assessment using the Perceived Pain Intensity Scale
Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post-intervention)
We will measure the changes in pain scores from baseline to end of intervention and end of post-intervention
Change from initial assessment, baseline, end of intervention and final assessment using the 6 Minute Walk Test
Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention, and final assessment at 16 weeks (8 weeks post- intervention)
We will measure the changes in distance walked during the 6 minute walk test
Change from initial assessment, baseline, end of intervention and final assessment using the Peripheral Artery Disease Quality of Life Questionnaire
Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention)
We will record and measure the changes in questionnaire scores from baseline to end of intervention and end of post-intervention

2 secondary outcomes

Change from initial assessment, baseline, end of intervention and final assessment using the Timed-Up-and-Go test
Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention)
Change from initial assessment, baseline, end of intervention and final assessment using the Intermittent Claudication Questionnaire (ICQ)
Time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
Derived from this study: PubMed 28595744Embrey DG, Alon G, Brandsma BA, Vladimir F, Silva A, Pflugeisen BM, Amoroso PJ. Functional electrical stimulation improves quality of life by reducing intermittent claudication. Int J Cardiol. 2017 Sep 15;243:454-459. doi: 10.1016/j.ijcard.2017.05.097. Epub 2017 Jun 2.
An introductory article about this NIH funded study and benefits of functional electrical stimulationLink provided by the sponsor.

Related trials for Peripheral Arterial Disease

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
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

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.

David G. Embrey, PT, PhD principal investigator

Principal Investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FES (Gait MyoElectric Stimulator) in people with Peripheral Arterial Disease, run by MultiCare Health System Research Institute 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 5 inclusion and 6 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 16 Aug 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from initial assessment, baseline, end of intervention and final assessment using the Perceived Pain Intensity Scale (time frame: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02384980, which also lists 1 linked publication.

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 16 Aug 2016.