Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by VascuActive LTD.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
VascuActive LTD
Information provided by:
VascuActive LTD
ClinicalTrials.gov Identifier:
NCT01214590
First received: October 3, 2010
Last updated: April 12, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetic Neuropathy, Painful |
Device: VascuActive device |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
U.S. FDA Resources
Further study details as provided by VascuActive LTD:
Primary Outcome Measures:
- 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)
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 15 |
| Study Start Date: | March 2011 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: VascuActive Treatment |
Device: VascuActive device
self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214590
Contacts
| Contact: Robert Slater, Dr. | +972(057)7346142 | SlaterDiabFoot@gmail.com |
Locations
| Israel | |
| Assaf Harofeh Medical Center, Diabetic Foot Clinic | Recruiting |
| Tzrifin, Israel | |
| Principal Investigator: Robert Slater, Dr. | |
| Principal Investigator: Arie Bass, Prof. | |
| Sub-Investigator: Micha Rapoport, Prof. | |
Sponsors and Collaborators
VascuActive LTD
Investigators
| Principal Investigator: | Arie Bass, Prof. | Assaf-Harofeh Medical Center |
| Principal Investigator: | Robert Slater, Dr. | Assaf-Harofeh Medical Center |
More Information
No publications provided
| Responsible Party: | Yuval Avni, CEO, VascuActive |
| ClinicalTrials.gov Identifier: | NCT01214590 History of Changes |
| Other Study ID Numbers: | VAS-02 |
| Study First Received: | October 3, 2010 |
| Last Updated: | April 12, 2011 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Additional relevant MeSH terms:
|
Diabetic Neuropathies Peripheral Nervous System Diseases Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Neuromuscular Diseases |
Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Signs and Symptoms Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 21, 2013