Back to resultsPreliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
Primary Purpose
Diabetic Neuropathy, Painful
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
VascuActive device
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy, Painful
Eligibility Criteria
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)
Sites / Locations
- Assaf Harofeh Medical Center, Diabetic Foot ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VascuActive Treatment
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Nerve conduction velocity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01214590
Brief Title
Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
Official Title
Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
VascuActive LTD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Painful
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VascuActive Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
VascuActive device
Intervention Description
self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session
Primary Outcome Measure Information:
Title
Diabetic neuropathic pain
Description
Pain will be assessed by several tools, including 11-point numeric scale, Brief Pain Inventory questionnaire, Pain relief scales (visual analog, categorical)
Time Frame
2, 4, 5, 12 weeks from start of treatment
Secondary Outcome Measure Information:
Title
Sensation impairment
Description
Touch sensation will be examined by the 5.07 Semmes-Weinstein monofilament (10 grams).
Vibraion sensation will be examined by a 128Hz fork.
Time Frame
2, 4, 5, 12 weeks from start of treatment
Title
Nerve conduction velocity
Time Frame
4, 12 weeks from start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Slater, Dr.
Phone
+972(057)7346142
Email
SlaterDiabFoot@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arie Bass, Prof.
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Slater, Dr.
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofeh Medical Center, Diabetic Foot Clinic
City
Tzrifin
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Slater, Dr.
First Name & Middle Initial & Last Name & Degree
Arie Bass, Prof.
First Name & Middle Initial & Last Name & Degree
Micha Rapoport, Prof.
12. IPD Sharing Statement
Learn more about this trial
Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
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