Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome
The investigators plan to perform an exploratory study to investigate the effects of electro-stimulation of the legs on the symptoms and clinical findings of post thrombotic syndrome (PTS), as well as quality of life of patients with PTS. The investigators theorize that electro-stimulation will provide both a mechanical benefit via muscular contraction and increased venous outflow from the affected extremity, as well as an anesthetic effect, which the investigators anticipate will translate into improved symptomatic outcomes, quality of life (QOL) benefits.
Post Thrombotic Syndrome
Deep Vein Thrombosis
Venous Stasis Syndrome
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Optimal Intensity and Frequency of a Portable Electrical Muscle Stimulator (VeinoPlus) to Improve Symptoms of Postthrombotic Syndrome|
- Estimate the optimal electrical stimulation intensity level at which patients using the portable electrical muscle stimulator (VeinoPlus®) have the largest benefit for relief of symptoms. [ Time Frame: visit 2 ] [ Designated as safety issue: No ]
- Estimate whether use of the device was a "clinical success" as defined by the patient reporting benefit by the improvement of symptoms after having used the device, plus an interest and willingness to continue using the device. [ Time Frame: visit 2 ] [ Designated as safety issue: No ]
- Estimate the extent to which the portable electrical muscle stimulator (VeinoPlus) improves the quality of life and objective findings of postthrombotic syndrome. [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
- Compute information needed to power a future cross-over study. [ Time Frame: after all visits completed ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.
The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months.
Other Name: Veinoplus
The purpose of this study is to determine the optimal electrical stimulation intensity level at which subjects using the portable electrical muscle stimulator (VeinoPlus) have the largest benefit for relief of post thrombotic symptoms. To determine if the subjects reported benefit from the device and willingness to continue using the device.
Subjects will be pre-screened on the phone for eligibility, and an initial appointment will be set. The subject will be given a device and complete a quality of life survey. The subject will also be assessed on the Villalta scale. After two months, the subjects will return for the final visit where the Villalta scale and quality of life survey will be reassessed, and the device taken back.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858130
|United States, North Carolina|
|University of North Carolina at Chapel Hill; University of North Carolina Hospitals|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Stephan Moll, MD||UNC Chapel Hill, Department of Medicine, Division of Hematology/Oncology|