Diabetic Neuropathy, PainfulNCT01214590
Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
A study testing VascuActive device in people with Diabetic Neuropathy, Painful, run by VascuActive LTD at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy, Painful
- What is being tested?
- VascuActive device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh Medical Center, Diabetic Foot Clinic
Tzrifin
Robert Slater, Dr.
Arie Bass, Prof.
About this study
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.
- Conditions
- Diabetic Neuropathy, Painful
- Being tested
- VascuActive device
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VascuActive deviceDevice
self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session
| Study group | Role | What they receive |
|---|---|---|
| VascuActive Treatment | Experimental | Not described Receives: Device: VascuActive device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2, 4, 5, 12 weeks from start of treatment
Secondary outcomes (2)
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.
Measured: 2, 4, 5, 12 weeks from start of treatment
Nerve conduction velocity
Measured: 4, 12 weeks from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startMar 2011
- Primary completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathy, PainfulStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VascuActive LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Arie Bass, Prof., Principal investigator, Assaf-Harofeh Medical CenterRobert Slater, Dr., Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214590
- Sponsor's protocol ID
- VAS-02
- Status last verified
- Apr 2011
- First submitted
- 3 Oct 2010
- Last updated
- 13 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT01214590
- Acronym / sponsor ID
- VAS-02
- Conditions
- Diabetic Neuropathy, Painful
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- VascuActive LTDIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Feb 2012 (estimated)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VascuActive Treatment | Experimental | Device: VascuActive device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VascuActive deviceself treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session | Device | VascuActive Treatment |
Primary outcome
Diabetic neuropathic pain
Time frame: 2, 4, 5, 12 weeks from start of treatment
Pain will be assessed by several tools, including 11-point numeric scale, Brief Pain Inventory questionnaire, Pain relief scales (visual analog, categorical)
2 secondary outcomes
Sensation impairment
Time frame: 2, 4, 5, 12 weeks from start of treatment
Nerve conduction velocity
Time frame: 4, 12 weeks from start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arie Bass, Prof. principal investigator
Assaf-Harofeh Medical Center
Robert Slater, Dr. principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VascuActive device in people with Diabetic Neuropathy, Painful, run by VascuActive LTD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Slater, Dr. (+972(057)7346142, SlaterDiabFoot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetic neuropathic pain (time frame: 2, 4, 5, 12 weeks from start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2011; AzTrials last refreshed its copy on 8 Nov 2026.