Status:
UNKNOWN
Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
Lead Sponsor:
VascuActive LTD
Conditions:
Diabetic Neuropathy, Painful
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01214590
Start Date
March 1 2011
Last Update
April 13 2011
Active Locations (1)
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1
Assaf Harofeh Medical Center, Diabetic Foot Clinic
Tzrifin, Israel