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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03512912
Other study ID # TESLA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2018
Est. completion date May 2020

Study information

Verified date May 2018
Source Heinrich-Heine University, Duesseldorf
Contact Philip Düppers, MD
Phone +492118117090
Email philip.dueppers@med.uni-duesseldorf.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date May 2020
Est. primary completion date May 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- intermittent claudication due to peripheral arterial disease

- ankle brachial index </=0.9

- occlusion or stenosis of the superficial femoral artery

Exclusion Criteria:

- 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

- 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

Study Design


Intervention

Device:
transcutaneous electrical calf muscle stimulation + supervised walking therapy
transcutaneous electrical calf muscle stimulation + supervised walking therapy

Locations

Country Name City State
Germany University Hospital Dusseldorf, Department of Vascular and Endovascular Surgery Dusseldorf NRW

Sponsors (1)

Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Walking distance Measurement of the pain-free and absolute walking distance on a standardized constant load treadmill test 6 months
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