Post Thrombotic SyndromeVeinoPlusNCT00858130
Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome (PTS)
A study testing VeinOPlus in people with Post Thrombotic Syndrome and Deep Vein Thrombosis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Thrombotic Syndrome, Deep Vein Thrombosis, Venous Stasis Syndrome
- What is being tested?
- VeinOPlus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill; University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
About this study
Official title: Optimal Intensity and Frequency of a Portable Electrical Muscle Stimulator (VeinoPlus) to Improve Symptoms of Postthrombotic Syndrome
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.
Read the 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.
- Conditions
- Post Thrombotic Syndrome, Deep Vein Thrombosis, Venous Stasis Syndrome, Venous Insufficiency, Postphlebitic Syndrome
- Being tested
- VeinOPlus
- Keywords
- Veinoplus, post thrombotic syndrome, deep vein thrombosis, electrical muscle stimulator, Venous stasis syndrome, venous insufficiency syndrome, Postphlebitic syndrome, history of deep vein thrombosis
- Medical subject headings
- Postthrombotic Syndrome, Venous Thrombosis, Venous Insufficiency, Postphlebitic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeinOPlusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Veinoplus | Experimental | Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects. Receives: Device: VeinOPlus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms
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.
Measured: Visit 2 (Week 8)
Secondary outcomes (4)
Number of Study Participants Classified as a "Clinical Success"
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."
Measured: Visit 2 (Week 8)
Number of Study Participants With Improvements in PTS Severity (Villalta Score)
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.
Measured: Visit 2 (Week 8)
Number of Study Participants With Improvements in QOL (VEINES-QOL Score)
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.
Measured: Vist 2 (Week 8)
Number of Study Participants With Improvements in Venous Symptoms (VEINES-Sym Score)
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.
Measured: Vist 2 (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Thrombotic SyndromeStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- VeinoPlus USA
- Responsible party
- Sponsor
- Investigators
- Stephan Moll, MD, Principal investigator, UNC Chapel Hill, Department of Medicine, Division of Hematology/Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858130
- Sponsor's protocol ID
- 08-2143Veinoplus
- Acronym
- VeinoPlus
- Status last verified
- Aug 2017
- First submitted
- 5 Mar 2009
- Last updated
- 29 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Intensity and Frequency of a Portable Electrical Muscle Stimulator (VeinoPlus) to Improve Symptoms of Postthrombotic Syndrome
- ClinicalTrials.gov ID
- NCT00858130
- Acronym / sponsor ID
- VeinoPlus / 08-2143Veinoplus
- Conditions
- Post Thrombotic Syndrome, Deep Vein Thrombosis, Venous Stasis Syndrome, Venous Insufficiency, Postphlebitic Syndrome
- Keywords
- Veinoplus, post thrombotic syndrome, deep vein thrombosis, electrical muscle stimulator, Venous stasis syndrome, venous insufficiency syndrome, Postphlebitic syndrome, history of deep vein thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- VeinoPlus USA
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Posted 29 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Veinoplus | Experimental | Device: VeinOPlusEvery subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VeinOPlusThe 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. | Device | Veinoplus |
Primary outcome
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.
4 secondary outcomes
Number of Study Participants Classified as a "Clinical Success"
Time frame: Visit 2 (Week 8)
Number of Study Participants With Improvements in PTS Severity (Villalta Score)
Time frame: Visit 2 (Week 8)
Number of Study Participants With Improvements in QOL (VEINES-QOL Score)
Time frame: Vist 2 (Week 8)
Number of Study Participants With Improvements in Venous Symptoms (VEINES-Sym Score)
Time frame: Vist 2 (Week 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Moll, MD principal investigator
UNC Chapel Hill, Department of Medicine, Division of Hematology/Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VeinOPlus in people with Post Thrombotic Syndrome and Deep Vein Thrombosis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms (time frame: Visit 2 (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.