Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
Recruitment status was: Recruiting
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.
|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|
- 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)
- 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 ]
|Study Start Date:||March 2011|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
|Experimental: VascuActive Treatment||
Device: VascuActive device
self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214590
|Assaf Harofeh Medical Center, Diabetic Foot Clinic|
|Principal Investigator:||Arie Bass, Prof.||Assaf-Harofeh Medical Center|
|Principal Investigator:||Robert Slater, Dr.||Assaf-Harofeh Medical Center|