ArteriopathyELECTROPADNCT03795103
Effect of a Neuromuscular Electrical Stimulation Program on Walking Capacity in Peripheral Artery Disease Patients
A study testing neuromuscular electrical stimulator, Walking sessions and Advices in people with Arteriopathy, run by Rennes University Hospital at 5 sites in France.
Trial summary
Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the… Read more about this study
- Who is it for?
- Ages 41 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arteriopathy
- What is being tested?
- neuromuscular electrical stimulator, Walking sessions and Advices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesFrance
- Study dates
- 9 Jan 2019to 22 Nov 2022
- 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 41 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Arteriopatic patients :
- Age > 40 years old.
- Subjects with Lower Extremity Peripheral Artery disease (LEPAD). LEPAD is defined by the presence of at least one of the following criteria:
- History of revascularization in the lower limbs due to LEPAD; OR
- Ankle brachial index (ABI) of ≤ 0.90; OR
- ABI or ankle systolic blood pressure decrease during recovery from treadmill walking test > 20 % or > 30 mmHg, respectively; OR
Show all 18Show fewer
- Toe-brachial index ≤0.70 if ABI cannot be measured and if incompressible arteries are suspected.
- Complain of exertional calf pain (fatigue, discomfort or cramping) that can begin or not at rest, causes the participant to stop walking and relieves or lessens within 10 minutes of rest (assessed using the San Diego questionnaire AND confirmed during treadmill testing);
- Pain (fatigue, discomfort or cramping) is mainly located at the calves' level.
- Maximal walking distance on treadmill < 300 m (treadmill protocol 3.2 km/h, 10% grade);
- Subject receiving from at least one month the recommend medical therapy for LEPAD management (antiplatelet therapy and statin medication).
- Obtained informed consent.
- Healthy volunteers
- Age > 50 years old;
- Absence of pain reported in the lower limbs during walking as supported by a negative score in the San Diego Questionnaire;
- Absence of any functional limitation during the treadmill walking test: 15 min of walking at 3.2 km/h and 10% slope;
- ABI ≥1.00 and ≤1.40.
- Obtained informed consent.
Who cannot join
- Arteriopatic patients :
- Patients with a pacemaker or defibrillator;
- Patients with acute or critical limb ischemia;
- Ambulation limited by exertional symptoms other than intermittent claudication (e.g., dyspnea or angina pectoris);
- Ambulation limited by exertional symptoms indicative of intermittent claudication but affecting muscles in the lower extremities other than the calves;
- Contraindication to exercise testing according to the American Heart Association and the American College of Sports Medicine;
Show all 35Show fewer
- Major cardiovascular event (myocardial infarction or stroke) or major surgery within the previous three months before inclusion;
- Female patients who are pregnant, planning to become pregnant, or lactating;
- Known presence of an aneurysm of the abdominal aorta > 4cm or an aneurysm of the iliac artery >1.5cm;
- Patient subject to legal protection (guardianship or tutelage measure) and persons deprived from their liberty (according to French law);
- Simultaneous participation to another ongoing clinical research protocol;
- Unwilling or unable to engage in the completion of a 12 week programme;
- Any planned event(s) that could interfere with the completion of the protocol: e.g., extended holidays preventing the completion of the intervention or planned hospitalization for a prolonged period of time.
- Body mass > 160 kg (may exceed treadmill limit).
- Inability to understand and sign informed consent forms due to cognitive or language barriers
- LEPAD due to other causes than atherosclerosis.
- Healthy volunteers :
- Contraindication to walking;
- ABI <1.00 or >1.40;
- Inability to obtain a measure of ABI due to uncompressible arteries;
- Limitation(s) and/or symptoms during the treadmill walking test;
- Treadmill walking test uncompleted.
- Presence of hypertension, heart failure, angina pectoris, diabetes, chronic obstructive pulmonary disease, supported by the presence of a medical treatment and the medical history.
- Presence of conditions likely to cause a functional limitation in walking and/or significant modification of physiological responses to the exercise: current or former smoker from less than 6 months, cancer (ongoing), Parkinson's disease, renal failure (ongoing), supported by the presence of a medical treatment and the medical history.
- History of cardiovascular disease (heart failure, stroke, myocardial infarction) reported by the patient.
- Female volunteers who are pregnant, planning to become pregnant, or lactating;
- Volunteers subject to legal protection (guardianship or tutelage measure) and persons deprived from their liberty (according to French law).
- Simultaneous participation to another ongoing clinical research protocol.
- Secondary exclusion criteria for patients :
- Patients requiring a pacemaker or defibrillator within the first three months.
- For the primary endpoint, patients who underwent revascularisation (surgical or endovascular) in the first three months.
- revascularisation (surgical or endovascular) in the first three months.
- 3. Any health events during the first three months that no longer allow the patient to follow the protocol.
- Burning during the electrostimulation sessions;
- Skin allergy due to the placement of the electro-stimulation electrodes
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Angers
Angers
CHU Brest
Brest, 29000
CHU Caen
Caen
CHU de Rennes
Rennes, 35033
Hôpital de Rangueil
Toulouse, 31403
About this study
Official title: Effect of a Neuromuscular Electrical Stimulation Program on Walking Capacity in Peripheral Artery Disease Patients: a Randomized Controlled Trial
Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life.
Interventions designed to improve walking impairment may have a significant impact on the functional capacity in LEPAD patients. Lower extremity electrical stimulation is an older technique that relies on different types of electrical stimulations with different expected physiological effects on hemodynamics, skeletal muscle functions or pain pathway. The aim of the ELECTRO-PAD study is to assess the effect of a 12 weeks program of neuromuscular electrical stimulation (NMES) on the absolute walking distance (AWD) measured during a treadmill test in peripheral artery disease patients.
Read the detailed description
The aim of the ELECTRO-PAD study is to assess the effect of a 12 weeks program of neuromuscular electrical stimulation (NMES) on the absolute walking distance (AWD) measured during a treadmill test in peripheral artery disease patients.
Arteriopatic patients will be randomized in 2 groups :
- patients submitted to a 12 weeks program of neuromuscular electrical stimulation (NMES group)
- patients without any program (control group) All patients will also receive a study participation guide that will include an information leaflet outlining tips for active living and walking.
After eligibility criteria will be assessed, patient will be included and randomized (visit 1). A second visit will be performed after 12 weeks (visit 2).
In parallel, 2 ancillary studies will be performed :
- Among Rennes' arteriopatic patients, endothelial function will be assessed using measures from 40 patients. Assessment will be done between 1 and 14 days after visit 1 (visit 1')
- The second ancillary study concerns 40 volunteers with no cardiac or vascular pathology, only in the coordinating center Rennes. The same measures will be performed for these volunteers and for arteriopatic patients.
- Conditions
- Arteriopathy
- Being tested
- neuromuscular electrical stimulator, Walking sessions, Advices
- Keywords
- Lower Extremity Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular electrical stimulatorDevice
A 12-week program of neuromuscular electrical stimulation
Walking sessionsOther
A 12-week program of walking sessions performed outdoors and independently
AdvicesOther
The usual practice associated with an information leaflet outlining tips for active living and walking.
| Study group | Role | What they receive |
|---|---|---|
| Patients achieving neuromuscular electrical stimulation | Experimental | LEPAD patients achieving a 12-week program of neuromuscular electrical stimulation. Group of arteriopathic patients who will perform electrostimulation sessions at home and independently. These patients will also receive a study participation guide that will include an information leaflet outlining tips for active living and walking. Receives: Device: neuromuscular electrical stimulator |
| Control | Other | Group of artriopathic patients who will maintain their usual drug management. These patients will also receive a study participation guide that will include an information leaflet outlining tips for active living and walking. Receives: Other: Advices |
| Healthy volunteers | Other | Ancillary study. Participants will perform a precise program of walking sessions performed outdoors and independently and the same biological parameters as those assessed in arteriopathic patients will be assessed Receives: Other: Walking sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in treadmill walking distance to maximal leg pain (absolute walking distance)
Comparison of change in treadmill walking distance to maximal leg pain (absolute walking distance) after 12 weeks between ESM group and control group (between visit 1 and visit 2)
Measured: 12 weeks
Secondary outcomes (13)
Change in treadmill walking distance to onset of leg pain
Comparison of change in treadmill walking distance to onset of leg pain between visit 1 and visit 2, and between NMES and control group
Measured: 12 weeks
Change in 6-minute total walk distance
Comparison of change in 6-minute total walk distance between visit 1 and visit 2, and between NMES and control group
Measured: 12 weeks
Change in maximal walking distance and medium walking speed under natural outdoor conditions
Comparison of change in maximal walking distance and medium walking speed under natural outdoor conditions between visit 1 and visit 2, and between NMES and control group
Measured: 12 weeks
Change in the Walking Impairment Questionnaire score
Comparison of change in the Walking Impairment Questionnaire (WIQ) score between visit 1 and visit 2 and between NMES and control group. the WIQ is a valid tool to detect improvement or deterioration in the daily walking ability of patients with intermittent claudication. The higher the WIQ score is, the better the patient's functional walking ability is.
Measured: 12 weeks
Change in the Short Form (36) Health Survey (SF36) score
Comparison of change in the Short Form (36) Health Survey (SF36) score between visit 1 and visit 2, and between NMES and control group. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software.
Measured: 12 weeks
Change in the Peripheral Artery Questionnaire (PAQ) score
Comparison of change in the Peripheral Artery Questionnaire score between visit 1 and visit 2, and between NMES and control group. The Peripheral Artery Questionnaire (PAQ) is a 20-item questionnaire developed to meet this need by quantifying patients' physical limitations, symptoms, social function, treatment satisfaction, and quality of life. higher scores represent fewer symptoms and better health status
Measured: 12 weeks
Change in in actigraphy measures
Comparison of change in actigraphy measures to define daily physical activity level between visit 1 and visit 2 and between NMES, and control group
Measured: 12 weeks
Change in ankle brachial index
Comparison of change in ankle brachial index between visit 1 and visit 2, and between NMES and control group. The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). Compared to the arm, lower blood pressure in the leg suggests blocked arteries due to peripheral artery disease (PAD). The ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm
Measured: 12 weeks
Change in TcPO2 DROP during treadmill walking test
Comparison of change in TcPO2 DROP during treadmill walking test between visit 1 and visit 2 and between NMES and control group
Measured: 12 weeks
Number of patients submitted to a revascularization procedure
Comparison in the number of patients submitted to a revascularization procedure between visit 1 and visit 2, and between NMES and control group
Measured: 12 weeks
Change in results of Contrast imaging with laser granularity
Comparison of change in endothelial function using Contrast imaging with laser granularity, only for arteriopathic patients included in Rennes, between visit 1 and visit 2 and between NMES and control group. Laser Contrast Granularity Analysis is a method that allows the visualization of tissue blood perfusion instantly in real time.
Measured: 12 weeks
Percentage of physiological response achieved by patients
Percentage of physiological response achieved by patients for all outcome measures (comparison with parameters of volunteers without any cardiac or vascular disease) between all visits
Measured: 12 weeks
Change in maximum walking distance according to the location of the arterial obstruction
Change in maximum walking distance according to the location of the arterial obstruction using scan images between visit 1 and visit 2 and between NMES and control group.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start9 Jan 2019
- Primary completion17 Nov 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArteriopathyStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AD REM TECHNOLOGY, Ecole Normale Supérieure de Rennes
- Responsible party
- Sponsor
- Investigators
- Guillaume Mahe, Pr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795103
- Sponsor's protocol ID
- 35RC15_8961_ELECTROPAD
- Acronym
- ELECTROPAD
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2018
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Le Faucheur A, Chanteau A, Jehannin P, Le Pabic E, Houssein A, Talbot M, Mimassi ML, Donnelly A, Espinasse B, Lecoq S, Bura-Riviere A, Kaladji A, Laneelle D, Mahe G. Effect of a home-based calf neuromuscular electrical stimulation program on walking capacity in adults with lower-extremity PAD: the ELECTRO-PAD RCT. Eur J Prev Cardiol. 2026 Feb 9:zwag080. doi: 10.1093/eurjpc/zwag080. Online ahead of print.
PubMed 41662341Jehannin P, Craughwell M, Omarjee L, Donnelly A, Jaquinandi V, Mahe G, Le Faucheur A. A systematic review of lower extremity electrical stimulation for treatment of walking impairment in peripheral artery disease. Vasc Med. 2020 Aug;25(4):354-363. doi: 10.1177/1358863X20902272. Epub 2020 Apr 17.
PubMed 32303155
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Neuromuscular Electrical Stimulation Program on Walking Capacity in Peripheral Artery Disease Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03795103
- Acronym / sponsor ID
- ELECTROPAD / 35RC15_8961_ELECTROPAD
- Conditions
- Arteriopathy
- Keywords
- Lower Extremity Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- AD REM TECHNOLOGY, Ecole Normale Supérieure de Rennes
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 7 Jan 2019 (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.
Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life.
Interventions designed to improve walking impairment may have a significant impact on the functional capacity in LEPAD patients. Lower extremity electrical stimulation is an older technique that relies on different types of electrical stimulations with different expected physiological effects on hemodynamics, skeletal muscle functions or pain pathway. The aim of the ELECTRO-PAD study is to assess the effect of a 12 weeks program of neuromuscular electrical stimulation (NMES) on the absolute walking distance (AWD) measured during a treadmill test in peripheral artery disease patients.
Detailed description
The aim of the ELECTRO-PAD study is to assess the effect of a 12 weeks program of neuromuscular electrical stimulation (NMES) on the absolute walking distance (AWD) measured during a treadmill test in peripheral artery disease patients.
Arteriopatic patients will be randomized in 2 groups :
- patients submitted to a 12 weeks program of neuromuscular electrical stimulation (NMES group)
- patients without any program (control group) All patients will also receive a study participation guide that will include an information leaflet outlining tips for active living and walking.
After eligibility criteria will be assessed, patient will be included and randomized (visit 1). A second visit will be performed after 12 weeks (visit 2).
In parallel, 2 ancillary studies will be performed :
- Among Rennes' arteriopatic patients, endothelial function will be assessed using measures from 40 patients. Assessment will be done between 1 and 14 days after visit 1 (visit 1')
- The second ancillary study concerns 40 volunteers with no cardiac or vascular pathology, only in the coordinating center Rennes. The same measures will be performed for these volunteers and for arteriopatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients achieving neuromuscular electrical stimulation | Experimental | Device: neuromuscular electrical stimulatorLEPAD patients achieving a 12-week program of neuromuscular electrical stimulation. Group of arteriopathic patients who will perform electrostimulation sessions at home and independently. These patients will also receive a study participation guide that will include an information leaflet outlining tips for active living and walking. |
| Control | Other | Other: AdvicesGroup of artriopathic patients who will maintain their usual drug management. These patients will also receive a study participation guide that will include an information leaflet outlining tips for active living and walking. |
| Healthy volunteers | Other | Other: Walking sessionsAncillary study. Participants will perform a precise program of walking sessions performed outdoors and independently and the same biological parameters as those assessed in arteriopathic patients will be assessed |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age > 40 years old.
- Subjects with Lower Extremity Peripheral Artery disease (LEPAD). LEPAD is defined by the presence of at least one of the following criteria:
- Complain of exertional calf pain (fatigue, discomfort or cramping) that can begin or not at rest, causes the participant to stop walking and relieves or lessens within 10 minutes of rest (assessed using the San Diego questionnaire AND confirmed during treadmill testing);
- Pain (fatigue, discomfort or cramping) is mainly located at the calves' level.
- Maximal walking distance on treadmill < 300 m (treadmill protocol 3.2 km/h, 10% grade);
Key exclusion criteria (35 listed)
- Patients with a pacemaker or defibrillator;
- Patients with acute or critical limb ischemia;
- Ambulation limited by exertional symptoms other than intermittent claudication (e.g., dyspnea or angina pectoris);
- Ambulation limited by exertional symptoms indicative of intermittent claudication but affecting muscles in the lower extremities other than the calves;
- Contraindication to exercise testing according to the American Heart Association and the American College of Sports Medicine;
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 |
|---|---|---|
| neuromuscular electrical stimulatorA 12-week program of neuromuscular electrical stimulation | Device | Patients achieving neuromuscular electrical stimulation |
| Walking sessionsA 12-week program of walking sessions performed outdoors and independently | Other | Healthy volunteers |
| AdvicesThe usual practice associated with an information leaflet outlining tips for active living and walking. | Other | Control |
Primary outcome
Change in treadmill walking distance to maximal leg pain (absolute walking distance)
Time frame: 12 weeks
Comparison of change in treadmill walking distance to maximal leg pain (absolute walking distance) after 12 weeks between ESM group and control group (between visit 1 and visit 2)
13 secondary outcomes
Change in treadmill walking distance to onset of leg pain
Time frame: 12 weeks
Change in 6-minute total walk distance
Time frame: 12 weeks
Change in maximal walking distance and medium walking speed under natural outdoor conditions
Time frame: 12 weeks
Change in the Walking Impairment Questionnaire score
Time frame: 12 weeks
Change in the Short Form (36) Health Survey (SF36) score
Time frame: 12 weeks
Change in the Peripheral Artery Questionnaire (PAQ) score
Time frame: 12 weeks
Change in in actigraphy measures
Time frame: 12 weeks
Change in ankle brachial index
Time frame: 12 weeks
Change in TcPO2 DROP during treadmill walking test
Time frame: 12 weeks
Number of patients submitted to a revascularization procedure
Time frame: 12 weeks
Change in results of Contrast imaging with laser granularity
Time frame: 12 weeks
Percentage of physiological response achieved by patients
Time frame: 12 weeks
Change in maximum walking distance according to the location of the arterial obstruction
Time frame: 12 weeks
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 23 Nov 2022.
- Derived from this study: PubMed 41662341Le Faucheur A, Chanteau A, Jehannin P, Le Pabic E, Houssein A, Talbot M, Mimassi ML, Donnelly A, Espinasse B, Lecoq S, Bura-Riviere A, Kaladji A, Laneelle D, Mahe G. Effect of a home-based calf neuromuscular electrical stimulation program on walking capacity in adults with lower-extremity PAD: the ELECTRO-PAD RCT. Eur J Prev Cardiol. 2026 Feb 9:zwag080. doi: 10.1093/eurjpc/zwag080. Online ahead of print.
- Derived from this study: PubMed 32303155Jehannin P, Craughwell M, Omarjee L, Donnelly A, Jaquinandi V, Mahe G, Le Faucheur A. A systematic review of lower extremity electrical stimulation for treatment of walking impairment in peripheral artery disease. Vasc Med. 2020 Aug;25(4):354-363. doi: 10.1177/1358863X20902272. Epub 2020 Apr 17.
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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.
Guillaume Mahe, Pr principal investigator
Rennes University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular electrical stimulator, Walking sessions and Advices in people with Arteriopathy, run by Rennes University Hospital at 5 sites in France.
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 18 inclusion and 35 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 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
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 in treadmill walking distance to maximal leg pain (absolute walking distance) (time frame: 12 weeks). 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 NCT03795103, which also lists 2 linked publications.
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 23 Nov 2022.