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

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ClinicalTrials.gov Identifier: NCT01214590
Recruitment Status : Unknown
Verified April 2011 by VascuActive LTD.
Recruitment status was:  Recruiting
First Posted : October 5, 2010
Last Update Posted : April 13, 2011
Sponsor:
Information provided by:
VascuActive LTD

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.


Condition or disease Intervention/treatment Phase
Diabetic Neuropathy, Painful Device: VascuActive device Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
Study Start Date : March 2011
Estimated Primary Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VascuActive Treatment Device: VascuActive device
self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session




Primary Outcome Measures :
  1. Diabetic neuropathic pain [ Time Frame: 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 Outcome Measures :
  1. Sensation impairment [ Time Frame: 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.


  2. Nerve conduction velocity [ Time Frame: 4, 12 weeks from start of treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214590


Contacts
Contact: Robert Slater, Dr. +972(057)7346142 SlaterDiabFoot@gmail.com

Locations
Israel
Assaf Harofeh Medical Center, Diabetic Foot Clinic Recruiting
Tzrifin, Israel
Principal Investigator: Robert Slater, Dr.         
Principal Investigator: Arie Bass, Prof.         
Sub-Investigator: Micha Rapoport, Prof.         
Sponsors and Collaborators
VascuActive LTD
Investigators
Principal Investigator: Arie Bass, Prof. Assaf-Harofeh Medical Center
Principal Investigator: Robert Slater, Dr. Assaf-Harofeh Medical Center

Responsible Party: Yuval Avni, CEO, VascuActive
ClinicalTrials.gov Identifier: NCT01214590     History of Changes
Other Study ID Numbers: VAS-02
First Posted: October 5, 2010    Key Record Dates
Last Update Posted: April 13, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases