Transcutaneous Electrostimulation for Intermittent Claudication Supervised Walking Therapy for Intermittent cLAudication

Peripheral Arterial Disease Clinical Trial

— TESLA  

Official title:

Transcutaneous Electrostimulation of the Calf Muscle and Supervised Walking Therapy for Intermittent cLAudication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03512912
• Other study ID #: TESLA
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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