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Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome (VeinoPlus)

This study has been completed.
University of North Carolina, Chapel Hill
VeinoPlus USA
Information provided by (Responsible Party):
Stephan Moll, MD, University of North Carolina, Chapel Hill Identifier:
First received: March 5, 2009
Last updated: February 2, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Post Thrombotic Syndrome
Deep Vein Thrombosis
Venous Stasis Syndrome
Venous Insufficiency
Postphlebitic Syndrome
Device: VeinOPlus
Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Stephan Moll, MD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: March 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Veinoplus
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.
Device: VeinOPlus
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.

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >18
  • Presence of previously objectively documented unilateral, lower extremity deep venous thrombosis
  • Presence of PTS (typical pain and swelling - worse after standing and vertical activity and relieved by rest and the horizontal position), severe enough that the patient is interested to explore a treatment option that might improve these symptoms. Symptoms had to have been stable for ≥ 3 months. Unstable symptoms are defined as: worsening, improving or variable symptoms over preceding months.
  • Subjects must be willing and able to give written informed consent.

Exclusion Criteria:

  • Inability or refusal to provide informed consent
  • Pregnancy
  • Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
  • Geographic inaccessibility to prevent scheduled return evaluations
  • Incapable of responding to questionnaires
  • Expected lifespan <6 months
  • Presence of cardiac pacemaker
  • History of cardiac arrhythmia
  • Presence of infected, or inflamed areas or skin eruptions; phlebitis, thrombophlebitis, active venous ulceration
  • History of seizures
  Contacts and Locations
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Please refer to this study by its 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
Sponsors and Collaborators
Stephan Moll, MD
University of North Carolina, Chapel Hill
VeinoPlus USA
Principal Investigator: Stephan Moll, MD UNC Chapel Hill, Department of Medicine, Division of Hematology/Oncology
  More Information

Responsible Party: Stephan Moll, MD, Associate Professor, University of North Carolina, Chapel Hill Identifier: NCT00858130     History of Changes
Other Study ID Numbers: 08-2143Veinoplus
Study First Received: March 5, 2009
Last Updated: February 2, 2016

Keywords provided by Stephan Moll, MD, University of North Carolina, Chapel Hill:
post thrombotic syndrome
deep vein thrombosis
electrical muscle stimulator
Venous stasis syndrome
venous insufficiency syndrome
Postphlebitic syndrome
history of deep vein thrombosis

Additional relevant MeSH terms:
Venous Thrombosis
Venous Insufficiency
Blind Loop Syndrome
Postphlebitic Syndrome
Postthrombotic Syndrome
Varicose Ulcer
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Peripheral Vascular Diseases
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases processed this record on May 25, 2017