Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and the preliminary efficacy of treatment by the VascuActive device on peripheral diabetic neuropathy, and to correlate this effect with physiologic changes. Patients will undergo a 4-week period of home treatment by the VascuActive device, and will be monitored during this period and during a two-month follow-up period for the efficacy of the device in reducing neuropathic pain, sensation impairment and other signs and symptoms.

Official Title
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Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy

Conditions
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Diabetic Neuropathy, Painful

Intervention / Treatment
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* Device: VascuActive device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes Mellitus (type 1 or 2) Age 18 years or older No changes within the last 3 months in diabetes medications, pain management medications, and symptoms associated with diabetes Painful diabetic neuropathy > 3 months, but not more than 5 years Pain level ≥ 4 on an 11 point Numerical Pain Rating Scale in both feet (average of two measurements, at least 1 week apart, during the 2 weeks prior to first treatment) Loss of protective sensation by the 5.07 Semmes-Weinstein Monofilament (SWM, 10gr.) monofilament test (in both feet, at least at 3 out of 10 points in each foot) Exclusion Criteria: Known or suspected radiculopathy (based on patient's record and anamnesis) Any painful condition that is difficult to distinguish from painful diabetic peripheral neuropathy Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive Severe cardiac disease or surgery within last 3 months, e.g., Acute Myocardial Infarction, Congestive Heart Failure grade 3 or higher Any major infectious, malignant or other severe systemic disease, including but not limited to Acquired Immune Deficiency Syndrome (AIDS), hepatitis, Creutzfeldt-Jakob disease Patient is incompetent to comply with study requirements (in the investigator's opinion)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VascuActive Treatment<br> | Device: VascuActive device<br>* self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetic neuropathic pain | Pain will be assessed by several tools, including 11-point numeric scale, Brief Pain Inventory questionnaire, Pain relief scales (visual analog, categorical) | 2, 4, 5, 12 weeks from start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensation impairment | Touch sensation will be examined by the 5.07 Semmes-Weinstein monofilament (10 grams). Vibraion sensation will be examined by a 128Hz fork. | 2, 4, 5, 12 weeks from start of treatment | 
| Nerve conduction velocity |  | 4, 12 weeks from start of treatment |