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

VascuActive

Status: Unknown

Conditions: Diabetic Neuropathy, Painful

Treatments: Device: VascuActive device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01214590

VAS-02

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

VascuActive Treatment

Experimental group

Treatment:

Device: VascuActive device