NCT03512912

Transcutaneous Electrostimulation for Intermittent Claudication Supervised Walking Therapy for Intermittent cLAudication

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	transcutaneous electrical calf muscle stimulation + supervised walking therapy	transcutaneous electrical calf muscle stimulation + supervised walking therapy

Timeline

• Start date: 2018-05-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2018-05-01
• Last updated: 2018-05-07

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study