Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome

This study has been completed.
Sponsor:
Collaborators:
Clinical and Translational Research Center at UNC Hospitals
VeinoPlus USA
Information provided by (Responsible Party):
Stephan Moll, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00858130
First received: March 5, 2009
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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: 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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

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.
Other Name: Veinoplus

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858130

Locations
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
Clinical and Translational Research Center at UNC Hospitals
VeinoPlus USA
Investigators
Principal Investigator: Stephan Moll, MD UNC Chapel Hill, Department of Medicine, Division of Hematology/Oncology
  More Information

No publications provided

Responsible Party: Stephan Moll, MD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00858130     History of Changes
Other Study ID Numbers: 08-2143Veinoplus
Study First Received: March 5, 2009
Last Updated: June 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Veinoplus
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:
Blind Loop Syndrome
Postphlebitic Syndrome
Postthrombotic Syndrome
Varicose Ulcer
Thrombosis
Venous Insufficiency
Venous Thrombosis
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014