Deep Vein Thrombosis, Postphlebitic Syndrome, Post Thrombotic Syndrome, Venous Insufficiency, Venous Stasis Syndrome
Conditions
Keywords
Veinoplus, post thrombotic syndrome, deep vein thrombosis, electrical muscle stimulator, Venous stasis syndrome, venous insufficiency syndrome, Postphlebitic syndrome, history of deep vein thrombosis
Brief 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. 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.
Interventions
DEVICEVeinOPlus
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.
Sponsors
VeinoPlus USA
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Participants Classified as a Clinical Success | 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) | 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) | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | VeinoPlus |
|---|---|
| Age, Continuous | 54 years |
| Leg Calf Circumference | 41 centimeters (cm) |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 2 Participants |
| VEINES-Quality of Life (QOL) | 48.30 units on a scale |
| VEINES-Sym | 46.93 units on a scale |
| Villalta Scale | 13 units on a scale |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: Visit 2 (Week 8)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| VeinoPlus | Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms | 32 mirco coulombs (0 to 50) |
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.
Time frame: Visit 2 (Week 8)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VeinoPlus | Number of Study Participants Classified as a Clinical Success | 7 Participants |
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.
Time frame: Visit 2 (Week 8)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VeinoPlus | Number of Study Participants With Improvements in PTS Severity (Villalta Score) | 8 Participants |
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.
Time frame: Vist 2 (Week 8)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VeinoPlus | Number of Study Participants With Improvements in QOL (VEINES-QOL Score) | 10 Participants |
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.
Time frame: Vist 2 (Week 8)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VeinoPlus | Number of Study Participants With Improvements in Venous Symptoms (VEINES-Sym Score) | 9 Participants |