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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by VascuActive LTD.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
VascuActive LTD
ClinicalTrials.gov Identifier:
NCT01214590
First received: October 3, 2010
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

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 Intervention
Diabetic Neuropathy, Painful
Device: VascuActive device

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by VascuActive LTD:

Primary Outcome Measures:
  • Diabetic neuropathic pain [ Time Frame: 2, 4, 5, 12 weeks from start of treatment ] [ Designated as safety issue: No ]
    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:
  • Sensation impairment [ Time Frame: 2, 4, 5, 12 weeks from start of treatment ] [ Designated as safety issue: No ]

    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 [ Time Frame: 4, 12 weeks from start of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2011
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VascuActive Treatment Device: VascuActive device
self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Yuval Avni, CEO, VascuActive
ClinicalTrials.gov Identifier: NCT01214590     History of Changes
Other Study ID Numbers: VAS-02
Study First Received: October 3, 2010
Last Updated: April 12, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on September 16, 2014