Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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)|
|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|
|Experimental: VascuActive Treatment||
Device: VascuActive device
self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session
- 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)
- 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.
- Nerve conduction velocity [ Time Frame: 4, 12 weeks from start of treatment ]
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
|Contact: Robert Slater, Dr.||+972(057)7346142||SlaterDiabFoot@gmail.com|
|Assaf Harofeh Medical Center, Diabetic Foot Clinic||Recruiting|
|Principal Investigator: Robert Slater, Dr.|
|Principal Investigator: Arie Bass, Prof.|
|Sub-Investigator: Micha Rapoport, Prof.|
|Principal Investigator:||Arie Bass, Prof.||Assaf-Harofeh Medical Center|
|Principal Investigator:||Robert Slater, Dr.||Assaf-Harofeh Medical Center|