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| Name | Class |
|---|---|
| VeinoPlus USA | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veinoplus | Experimental | Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VeinOPlus | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 2 (Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Moll, MD | UNC Chapel Hill, Department of Medicine, Division of Hematology/Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill; University of North Carolina Hospitals | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | VeinoPlus | Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VeinoPlus | Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | mirco coulombs (0 to 50) | Visit 2 (Week 8) |
|
Adverse event data was collected for the entire duration of study subject participation which was 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VeinoPlus Experimental Arm | Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| "pinhole leak" near subject's left ankle | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Subject got a "pinhole leak" near her left ankle that releases fluid. Subject has discontinued using the device on her left leg. This adverse event did not result in hospital admission or prolongation of hospitalization. |
Given its small sample size (n=12), this study provides rationale and details needed for a larger randomized, placebo controlled, and double-blinded trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephan Moll, Professor of Hemology/Oncology | University of North Carolina at Chapel Hill | 919-966-3311 | stephan_moll@med.unc.edu |
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| ID | Term |
|---|---|
| D054070 | Postthrombotic Syndrome |
| D020246 | Venous Thrombosis |
| D014689 | Venous Insufficiency |
| D011186 | Postphlebitic Syndrome |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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|
| 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. | 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. | 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. | Vist 2 (Week 8) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Leg Calf Circumference | Leg measurements around the largest part of both calves were taken. | Median | Full Range | centimeters (cm) |
|
| Villalta Scale | The Villalta PTS scale is based on patient symptoms including cramps, pain, and redness. The severity of PTS was categorized using the Villalta scale. Points are given for 11 descriptors according to severity ranging from 0 (not present) to 3 (severe) with overall scores 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. | Median | Full Range | units on a scale |
|
| VEINES-Quality of Life (QOL) | The VEINES-QOL/Sym Questionnaire is a patient-based questionnaire designed for self-completion and measures the impact of deep venous thrombosis (DVT) on symptoms and quality of life from the patient's perspective. It contains 26 items covering symptoms, limitations in daily activities, and psychological impact of patients with a DVT. Summary scores are generated for disease specific quality of life (VEINES-QOL) and venous symptoms (VEINES-Sym) each ranging from 0 to 100. For the VEINES-QOL, higher scores indicate a better quality of life. | Median | Full Range | units on a scale |
|
| VEINES-Sym | The VEINES-QOL/Sym Questionnaire is a patient-based questionnaire designed for self-completion and measures the impact of deep venous thrombosis (DVT) on symptoms and quality of life from the patient's perspective. It contains 26 items covering symptoms, limitations in daily activities, and psychological impact of patients with a DVT. Summary scores are generated for disease specific quality of life (VEINES-QOL) and venous symptoms (VEINES-Sym) each ranging from 0 to 100. For the VEINES-Sym, higher scores indicate better outcomes. | Median | Full Range | units on a scale |
|
| VeinoPlus |
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects. 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. |
|
|
| Secondary | 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." | Posted | Count of Participants | Participants | Visit 2 (Week 8) |
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|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Visit 2 (Week 8) |
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|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Vist 2 (Week 8) |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Vist 2 (Week 8) |
|
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| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
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| D010689 |
| Phlebitis |
| D016491 | Peripheral Vascular Diseases |