Diabetic Neuropathy, Painful
Conditions
Brief summary
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.
Interventions
DEVICEVascuActive device
self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session
Sponsors
VascuActive LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetic neuropathic pain | 2, 4, 5, 12 weeks from start of treatment | Pain will be assessed by several tools, including 11-point numeric scale, Brief Pain Inventory questionnaire, Pain relief scales (visual analog, categorical) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensation impairment | 2, 4, 5, 12 weeks from start of treatment | Touch sensation will be examined by the 5.07 Semmes-Weinstein monofilament (10 grams). Vibraion sensation will be examined by a 128Hz fork. |
| Nerve conduction velocity | 4, 12 weeks from start of treatment | — |
Countries
Israel
Contacts
Primary ContactRobert Slater, Dr.
Outcome results
None listed