Transcutaneous Electrostimulation for Intermittent Claudication Supervised Walking Therapy for Intermittent cLAudication

NCT ID: NCT03512912

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2020-05-31

Brief 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.

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.

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

transcutaneous electrical calf muscle stimulation + supervised walking therapy

transcutaneous electrical calf muscle stimulation + supervised walking therapy

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Dr. Philip Düppers

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Düppers, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Vascular and Endovascular Surgery

Locations

University Hospital Dusseldorf, Department of Vascular and Endovascular Surgery

Düsseldorf, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Philip Düppers, MD

Role: CONTACT

philip.dueppers@med.uni-duesseldorf.de

+492118117090

Facility Contacts

Philip Düppers, MD

Role: primary

philip.dueppers@med.uni-duesseldorf.de

+492118117090

Other Identifiers

TESLA

Identifier Type: -

Identifier Source: org_study_id