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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01214590
Other study ID # VAS-02
Secondary ID
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. completion date
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


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
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