Transcutaneous Electrostimulation for Intermittent Claudication Supervised Walking Therapy for Intermittent cLAudication

NCT03512912 | Unknown FDA Device

• 1 other identifier: TESLA
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Walking distance

  Measurement of the pain-free and absolute walking distance on a standardized constant load treadmill test

  6 months

Interventions

transcutaneous electrical calf muscle stimulation + supervised walking therapy DEVICE

transcutaneous electrical calf muscle stimulation + supervised walking therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• intermittent claudication due to peripheral arterial disease
• ankle brachial index \</=0.9
• occlusion or stenosis of the superficial femoral artery

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University Hospital Dusseldorf, Department of Vascular and Endovascular Surgery

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Philip Düppers, MD

  Department of Vascular and Endovascular Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Düppers, MD

CONTACT

+492118117090; philip.dueppers@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 7, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)