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

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 Overview

• Status: Unknown
• Conditions: Diabetic Neuropathy, Painful
• Intervention / Treatment: Device: VascuActive device

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Slater, Dr.; Phone Number: +972(057)7346142; Email: SlaterDiabFoot@gmail.com

Study Locations

• Israel
  • Tzrifin, Israel
    • Recruiting
    • Assaf Harofeh Medical Center, Diabetic Foot Clinic
    • Principal Investigator: Robert Slater, Dr.
    • Principal Investigator: Arie Bass, Prof.
    • Sub-Investigator: Micha Rapoport, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetic neuropathic pain	Pain will be assessed by several tools, including 11-point numeric scale, Brief Pain Inventory questionnaire, Pain relief scales (visual analog, categorical)	2, 4, 5, 12 weeks from start of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensation impairment	Touch sensation will be examined by the 5.07 Semmes-Weinstein monofilament (10 grams). Vibraion sensation will be examined by a 128Hz fork.	2, 4, 5, 12 weeks from start of treatment
Nerve conduction velocity		4, 12 weeks from start of treatment

Collaborators and Investigators

• Sponsor: VascuActive LTD
• Investigators: Principal Investigator: Arie Bass, Prof., Assaf-Harofeh Medical Center; Principal Investigator: Robert Slater, Dr., Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ANTICIPATED): February 1, 2012

Study Registration Dates

• First Submitted: October 3, 2010
• First Submitted That Met QC Criteria: October 3, 2010
• First Posted (ESTIMATE): October 5, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 13, 2011
• Last Update Submitted That Met QC Criteria: April 12, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: VAS-02