Transcutaneous Electrostimulation for Intermittent Claudication Supervised Walking Therapy for Intermittent cLAudication (TESLA)

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease; Intermittent Claudication
• Intervention / Treatment: Device: transcutaneous electrical calf muscle stimulation + supervised walking therapy

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Dusseldorf, NRW, Germany, 40225
      • Recruiting
      • University Hospital Dusseldorf, Department of Vascular and Endovascular Surgery
      • Contact: Philip Düppers, MD; Phone Number: +492118117090; Email: philip.dueppers@med.uni-duesseldorf.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients of our department of vascular end endovascular surgery, university hospital Dusseldorf with the above mentioned inclusion criteria.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking distance	Measurement of the pain-free and absolute walking distance on a standardized constant load treadmill test	6 months

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Principal Investigator: Philip Düppers, MD, Department of Vascular and Endovascular Surgery

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2018
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (ACTUAL): May 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: TESLA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No