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

Diabetic Neuropathy, Painful Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01214590
• Other study ID #: VAS-02
• Status: Recruiting
• Phase: N/A
• First received: October 3, 2010
• Last updated: April 12, 2011
• Start date: March 2011

Study information

• Verified date: April 2011
• Source: VascuActive LTD
• Contact: Robert Slater, Dr.
• Phone: +972(057)7346142
• Email: SlaterDiabFoot[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy, Painful
• Peripheral Nervous System Diseases

Intervention

Device:
• VascuActive device
self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center, Diabetic Foot Clinic	Tzrifin

Sponsors (1)

Lead Sponsor	Collaborator
VascuActive LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Nerve conduction velocity		4, 12 weeks from start of treatment	No