Intermittent ClaudicationTESLANCT03512912
Transcutaneous Electrostimulation for Intermittent Claudication Supervised Walking Therapy for Intermittent cLAudication
An observational study of Intermittent Claudication and Peripheral Arterial Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Prospective mono-centric trial on patients with peripheral arterial disease and intermittent claudication that receive supervised exercise therapy (group 1) vs. supervised exercise therapy + daily transcutaneous electro-stimulation of the calf muscles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Claudication, Peripheral Arterial Disease
- What is being tested?
- transcutaneous electrical calf muscle stimulation + supervised walking therapy
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- May 2018to May 2020
- Phase
- Observational
- 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
Study population: All patients of our department of vascular end endovascular surgery, university hospital Dusseldorf with the above mentioned inclusion criteria.
Who may be able to join
- intermittent claudication due to peripheral arterial disease
- ankle brachial index </=0.9
- occlusion or stenosis of the superficial femoral artery
Who cannot join
- rest pain or peripheral arterial lesions
- contraindications for supervised walking therapy
- non-vascular conditions that limit patients´ walking ability
- patients that have already received supervised walking therapy
- occlusion of the deep femoral artery
- occlusion or high-grade stenoses of the iliac arteries
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- stroke in the last 12 months
- premenopausal women
- diabetes mellitus, dialysis, sclerodermia and other conditions that impair leg perfusion
- active cilostazol therapy or alprostadil-infusion in the last 3 months
- pacemaker, defibrillator systems, life vest
- visible muscle contraction is not achieved without pain
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Dusseldorf, Department of Vascular and Endovascular Surgery
Düsseldorf, North Rhine-Westphalia, 40225
Philip Düppers, MD, +492118117090, philip.dueppers@med.uni-duesseldorf.de
About this study
Official title: Transcutaneous Electrostimulation of the Calf Muscle and Supervised Walking Therapy for Intermittent cLAudication
Prospective mono-centric trial on patients with peripheral arterial disease and intermittent claudication that receive supervised exercise therapy (group 1) vs. supervised exercise therapy + daily transcutaneous electro-stimulation of the calf muscles.
Read the detailed description
The investigators conduct a prospective mono-centric trial on all patient with peripheral arterial disease with intermittent claudication that receive supervised exercise therapy (SET) and additional transcutaneous electric stimulation (TES) of the calf muscle. SET program consists in once weekly walking training for 75 min under supervision of a professional trainer. Patients are encouraged to continue the training modules at home. TES is performed using the mobile "Veinoplus arterial" device (AdRem Technology, France) on a daily base for 60-120 min at home. Patient outcome will be compared to the retrospectively analyzed results of patients, that received the same SET program alone in the past.
- Being tested
- transcutaneous electrical calf muscle stimulation + supervised walking therapy
- Medical subject headings
- Intermittent Claudication, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical calf muscle stimulation + supervised walking therapyDevice
transcutaneous electrical calf muscle stimulation + supervised walking therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking distance
Measurement of the pain-free and absolute walking distance on a standardized constant load treadmill test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study startMay 2018 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (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.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Philip Düppers, Heinrich-Heine University, Duesseldorf
- Investigators
- Philip Düppers, MD, Principal investigator, Department of Vascular and Endovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512912
- Sponsor's protocol ID
- TESLA
- Acronym
- TESLA
- Status last verified
- May 2018
- First submitted
- 19 Apr 2018
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrostimulation of the Calf Muscle and Supervised Walking Therapy for Intermittent cLAudication
- ClinicalTrials.gov ID
- NCT03512912
- Acronym / sponsor ID
- TESLA / TESLA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 1 May 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.
Prospective mono-centric trial on patients with peripheral arterial disease and intermittent claudication that receive supervised exercise therapy (group 1) vs. supervised exercise therapy + daily transcutaneous electro-stimulation of the calf muscles.
Detailed description
The investigators conduct a prospective mono-centric trial on all patient with peripheral arterial disease with intermittent claudication that receive supervised exercise therapy (SET) and additional transcutaneous electric stimulation (TES) of the calf muscle. SET program consists in once weekly walking training for 75 min under supervision of a professional trainer. Patients are encouraged to continue the training modules at home. TES is performed using the mobile "Veinoplus arterial" device (AdRem Technology, France) on a daily base for 60-120 min at home. Patient outcome will be compared to the retrospectively analyzed results of patients, that received the same SET program alone in the past.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of our department of vascular end endovascular surgery, university hospital Dusseldorf with the above mentioned inclusion criteria.
Key inclusion criteria (3 listed)
- intermittent claudication due to peripheral arterial disease
- ankle brachial index </=0.9
- occlusion or stenosis of the superficial femoral artery
Key exclusion criteria (12 listed)
- rest pain or peripheral arterial lesions
- contraindications for supervised walking therapy
- non-vascular conditions that limit patients´ walking ability
- patients that have already received supervised walking therapy
- occlusion of the deep femoral artery
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 |
|---|---|---|
| transcutaneous electrical calf muscle stimulation + supervised walking therapytranscutaneous electrical calf muscle stimulation + supervised walking therapy | Device | – |
Primary outcome
Walking distance
Time frame: 6 months
Measurement of the pain-free and absolute walking distance on a standardized constant load treadmill test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Individual participant dataSharing planned: No
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EVERO Drug-coated Balloon (DCB) Randomized Trial
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Improving Mobility After Revascularization in Peripheral Artery Disease
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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.
Philip Düppers, MD principal investigator
Department of Vascular and Endovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intermittent Claudication and Peripheral Arterial Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 12 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 7 May 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 Germany. 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 Philip Düppers, MD (+492118117090, philip.dueppers@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking distance (time frame: 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 7 May 2018; AzTrials last refreshed its copy on 3 Nov 2026.