Clinical Trial: Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Optimal Intensity and Frequency of a Portable Electrical Muscle Stimulator (VeinoPlus) to Improve Symptoms of Postthrombotic Syndrome

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Stephan Moll, MD

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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 ]
  • Compute information needed to power a future cross-over study. [ Time Frame: after all visits completed ]


Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: March 5, 2009
Date Started: March 2009
Date Completion:
Last Updated: February 2, 2016
Last Verified: February 2016