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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00858130
First Posted: March 9, 2009
Last Update Posted: November 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
VeinoPlus USA
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
  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
Post Thrombotic Syndrome Deep Vein Thrombosis Venous Stasis Syndrome Venous Insufficiency Postphlebitic Syndrome Device: VeinOPlus

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Patients were told to use different voltages and numbers of treatment periods, and experiment with pad placement, to find intensity, frequency of use, and pad position for optimal PTS symptom relief. Assessments (Villalta score, QOL questionnaire, calf circumference) were obtained at study entry and after 8 weeks of device use.
Masking: None (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 University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms [ Time Frame: Visit 2 (Week 8) ]
    The VeinoPlus® electrically stimulates leg muscles via motor nerves, causing muscle contractions. Two electrode pads are placed on the skin of the leg. Pad positions can be chosen by the patient, such as (a) both pads on the calf muscle of one leg, (b) one pad on the calf muscle and one on the plantar aspect of the foot of one leg, and (c) a pad posteriorly on each calf. Length of treatment is programmed into the device and is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations during the treatment cycle if desired. The intensity ranges from zero to fifty, with zero being no electrical stimulation, and fifty the highest intensity, which carries low quantities of electrical energy (<5 micro coulombs). In this study subjects used the device at any setting, as many times a day as they liked, and varying the placement of the electrodes.


Secondary Outcome Measures:
  • Number of Study Participants Classified as a "Clinical Success" [ Time Frame: Visit 2 (Week 8) ]
    Clinical success was defined by the patient reporting benefit (moderate improvement of symptoms after having used the device) and an interest and willingness to continue using the device. For this study both legs were measured, but only the more severely affected leg (as determined by higher Villalta score) was used to determine clinical success. Patients were asked the following question: "How much have symptoms improved?" with the following possible responses: "a little;" "moderate;" "a good deal;" "a great deal;" or "a very great deal."

  • Number of Study Participants With Improvements in PTS Severity (Villalta Score) [ Time Frame: Visit 2 (Week 8) ]
    The Villalta PTS scale is based on patient symptoms including cramps, pain, and redness and was used to characterize PTS severity. Points are given for 11 descriptors according to severity from 0 (not present) to 3 (severe) with overall scores ranging from 0 to 33. Higher scores represent more severe disease. A score of ≥ 5 indicated mild PTS; 10-14 moderate PTS; and a score of ≥15, or the presence of a venous ulcer, indicated severe PTS. Those participants with a Villalta score decrease at Visit 2 in comparison to Visit 1 were counted as having improved.

  • Number of Study Participants With Improvements in QOL (VEINES-QOL Score) [ Time Frame: Vist 2 (Week 8) ]
    The VEINES-QOL/Sym is a patient-based questionnaire designed for self-completion and measures DVT impact on symptoms and QOL from patients' perspective. It contains 26 items covering patient DVT: symptoms, limitations in daily activities, and psychological impact. Two separate summary scores are produced ranging from 0 to 100; a disease-specific QOL (VEINES-QOL) and venous symptoms (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym, higher scores indicate a better QOL. Instruments were completed at Visits 1 and 2 (Follow-up). Those participants with a VEINES-QOL score increase at Visit 2 in comparison to Visit 1 were counted as having improved.

  • Number of Study Participants With Improvements in Venous Symptoms (VEINES-Sym Score) [ Time Frame: Vist 2 (Week 8) ]
    The VEINES-QOL/Sym is a patient-based questionnaire designed for self-completion and measures DVT impact on symptoms and QOL from patients' perspective. It contains 26 items covering patient DVT: symptoms, limitations in daily activities, and psychological impact. Two separate summary scores are produced ranging from 0 to 100; a disease-specific QOL (VEINES-QOL) and venous symptoms (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym, higher scores indicate a better QOL. Instruments were completed at Visits 1 and 2 (Follow-up). Those participants with a VEINES-Sym score increase at Visit 2 in comparison to Visit 1 were counted as having improved.


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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
University of North Carolina, Chapel Hill
VeinoPlus USA
Investigators
Principal Investigator: Stephan Moll, MD UNC Chapel Hill, Department of Medicine, Division of Hematology/Oncology
  More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00858130     History of Changes
Other Study ID Numbers: 08-2143Veinoplus
First Submitted: March 5, 2009
First Posted: March 9, 2009
Results First Submitted: March 16, 2017
Results First Posted: November 29, 2017
Last Update Posted: November 29, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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:
Syndrome
Thrombosis
Venous Thrombosis
Venous Insufficiency
Postphlebitic Syndrome
Postthrombotic Syndrome
Varicose Ulcer
Blind Loop Syndrome
Disease
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases