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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

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.

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Detailed Description

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Conditions

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Diabetic Neuropathy, Painful

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VascuActive Treatment

Group Type EXPERIMENTAL

VascuActive device

Intervention Type DEVICE

self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session

Interventions

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VascuActive device

self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No