Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome - Full Text View

Sponsors and Collaborators:	The University of North Carolina, Chapel Hill Clinical and Translational Research Center at UNC Hospitals VeinoPlus USA
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00858130

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 Syndrome Postphlebitic Syndrome	Device: VeinOPlus	Phase II Phase III

MedlinePlus related topics: Deep Vein Thrombosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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 The 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 ]

Estimated Enrollment:	12
Study Start Date:	March 2009
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Veinoplus: Experimental 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.

Arms

Assigned Interventions

Veinoplus: Experimental

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.

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

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

Contacts

Contact: Catherine Soriano, BS	919-966-2359	catherine_soriano@med.unc.edu
Contact: Cheryl Jeanneret, BS	919-966-3311	cheryl_jeanneret@med.unc.edu

Locations

United States, North Carolina
University of North Carolina at Chapel Hill; University of North Carolina Hospitals	Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Stephan Moll, MD

Sponsors and Collaborators

The University of North Carolina, Chapel Hill

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:	UNC-Chapel Hill Department of Medicine, Division of Hematology/Oncology ( Stephan Moll, MD )
Study ID Numbers:	Veinoplus08-2143, IRB 08-2143, CTRC 2814
Study First Received:	March 5, 2009
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00858130 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The 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

Study placed in the following topic categories:

Peripheral Vascular Diseases
Blind Loop Syndrome
Metabolic Diseases
Gastrointestinal Diseases
Vascular Diseases
Postthrombotic Syndrome
Intestinal Diseases
Thrombosis
Embolism and Thrombosis

Digestive System Diseases
Embolism
Phlebitis
Venous Insufficiency
Malabsorption Syndromes
Venous Thrombosis
Metabolic Disorder
Postphlebitic Syndrome

Additional relevant MeSH terms:

Disease
Peripheral Vascular Diseases
Blind Loop Syndrome
Metabolic Diseases
Gastrointestinal Diseases
Vascular Diseases
Postthrombotic Syndrome
Intestinal Diseases
Thrombosis
Embolism and Thrombosis

Pathologic Processes
Digestive System Diseases
Syndrome
Phlebitis
Venous Insufficiency
Malabsorption Syndromes
Cardiovascular Diseases
Venous Thrombosis
Postphlebitic Syndrome

ClinicalTrials.gov processed this record on May 06, 2009