Painful Diabetic NeuropathyPhase 2/3NCT00337324
Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy
A Phase 2/3 study testing Frequency-modulated electromagnetic neural stimulation in people with Painful Diabetic Neuropathy, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
We postulate that frequency-modulated electromagnetic stimulation (FREMS) may decrease pain in patients with painful diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- Frequency-modulated electromagnetic neural stimulation
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2002to May 2004
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 1 or type 2 diabetes (American Diabetes Association criteria)
- painful diabetic neuropathy with reduced sensory/motor nerve conduction velocity (i.e., <40 m/sec in at least one nerve trunk of the lower limbs)
- vibration perception at the big toe >25 V
Who cannot join
- presence of any concomitant severe disease
- pregnancy
- renal disease (serum creatinine >2.0 mg/dL)
- history or current foot ulcer
- lower limb arterial disease (ankle-brachial index <0.9) or transcutaneous partial pressure of oxygen <50 mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Transcutaneous Neurostimulation and Biofeedback (FREMS)in Patients With Diabetic Neuropathy
We postulate that frequency-modulated electromagnetic stimulation (FREMS) may decrease pain in patients with painful diabetic neuropathy.
Read the detailed description
The stuy was designed as a randomized, double-blind, placebo-controlled cross-over trial. Each patient received two series of ten treatments of either FREMS or placebo in random sequence, with each series lasting no more than three weeks. Primary outcomes (daytime and night-time pain scores) an secondary outcomes (Motor and sensory nerve conduction velocity, sensory tactile perception, foot vibration perception threshold, quality of life, cutaneous microvascular flow, partial tissue tension of oxygen and carbon dioxide) were measured at baseline, after FREMS/placebo series and after 4 months follow-up.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- Frequency-modulated electromagnetic neural stimulation
- Keywords
- Diabetic neuropathy, Complications of diabetes, Neuropathies, Electromagnetic stimulation, Neuropathic pain
- Medical subject headings
- Diabetic Neuropathies, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequency-modulated electromagnetic neural stimulationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up
Secondary outcomes (7)
Measurements of the following parameters were made at baseline, after FREMS/placebo, and 4 month follow-up:
Motor and sensory nerve conduction velocity
Sensory tactile perception by monofilament
Foot vibration perception threshold by biothesiometer
Quality of life by SF-36 instrument
Cutaneous microvascular flow by laser doppler
Partial tissue tension of oxygen and carbon dioxide by oxymetry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Study startMar 2002
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Painful Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 38 participants
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Lorenz Biotech S.p.A., University Of Perugia
- Investigators
- Emanuele Bosi, MD, Principal investigator, San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milano (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337324
- Sponsor's protocol ID
- LORENZ/01
- Status last verified
- Mar 2002
- First submitted
- 14 Jun 2006
- Last updated
- 15 Jun 2006
- Results posted
- No
Publications
Bosi E, Conti M, Vermigli C, Cazzetta G, Peretti E, Cordoni MC, Galimberti G, Scionti L. Effectiveness of frequency-modulated electromagnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia. 2005 May;48(5):817-23. doi: 10.1007/s00125-005-1734-2. Epub 2005 Apr 15.
PubMed 15834546Conti M, Peretti E, Cazzetta G, Galimberti G, Vermigli C, Pola R, Scionti L, Bosi E. Frequency-modulated electromagnetic neural stimulation enhances cutaneous microvascular flow in patients with diabetic neuropathy. J Diabetes Complications. 2009 Jan-Feb;23(1):46-8. doi: 10.1016/j.jdiacomp.2008.02.004. Epub 2008 Apr 10.
PubMed 18403219
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Transcutaneous Neurostimulation and Biofeedback (FREMS)in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00337324
- Acronym / sponsor ID
- LORENZ/01
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- Diabetic neuropathy, Complications of diabetes, Neuropathies, Electromagnetic stimulation, Neuropathic pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Lorenz Biotech S.p.A., University Of Perugia
- Study start
- Mar 2002
- Study completion
- May 2004
- First posted
- 15 Jun 2006 (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.
We postulate that frequency-modulated electromagnetic stimulation (FREMS) may decrease pain in patients with painful diabetic neuropathy.
Detailed description
The stuy was designed as a randomized, double-blind, placebo-controlled cross-over trial. Each patient received two series of ten treatments of either FREMS or placebo in random sequence, with each series lasting no more than three weeks. Primary outcomes (daytime and night-time pain scores) an secondary outcomes (Motor and sensory nerve conduction velocity, sensory tactile perception, foot vibration perception threshold, quality of life, cutaneous microvascular flow, partial tissue tension of oxygen and carbon dioxide) were measured at baseline, after FREMS/placebo series and after 4 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 1 or type 2 diabetes (American Diabetes Association criteria)
- painful diabetic neuropathy with reduced sensory/motor nerve conduction velocity (i.e., <40 m/sec in at least one nerve trunk of the lower limbs)
- vibration perception at the big toe >25 V
Key exclusion criteria (5 listed)
- presence of any concomitant severe disease
- pregnancy
- renal disease (serum creatinine >2.0 mg/dL)
- history or current foot ulcer
- lower limb arterial disease (ankle-brachial index <0.9) or transcutaneous partial pressure of oxygen <50 mmHg)
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 |
|---|---|---|
| Frequency-modulated electromagnetic neural stimulation | Device | – |
Primary outcome
Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up
7 secondary outcomes
Measurements of the following parameters were made at baseline, after FREMS/placebo, and 4 month follow-up:
Motor and sensory nerve conduction velocity
Sensory tactile perception by monofilament
Foot vibration perception threshold by biothesiometer
Quality of life by SF-36 instrument
Cutaneous microvascular flow by laser doppler
Partial tissue tension of oxygen and carbon dioxide by oxymetry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2006.
- Results publication: PubMed 15834546Bosi E, Conti M, Vermigli C, Cazzetta G, Peretti E, Cordoni MC, Galimberti G, Scionti L. Effectiveness of frequency-modulated electromagnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia. 2005 May;48(5):817-23. doi: 10.1007/s00125-005-1734-2. Epub 2005 Apr 15.
- Derived from this study: PubMed 18403219Conti M, Peretti E, Cazzetta G, Galimberti G, Vermigli C, Pola R, Scionti L, Bosi E. Frequency-modulated electromagnetic neural stimulation enhances cutaneous microvascular flow in patients with diabetic neuropathy. J Diabetes Complications. 2009 Jan-Feb;23(1):46-8. doi: 10.1016/j.jdiacomp.2008.02.004. Epub 2008 Apr 10.
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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.
Emanuele Bosi, MD principal investigator
San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milano (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Frequency-modulated electromagnetic neural stimulation in people with Painful Diabetic Neuropathy, run by IRCCS San Raffaele at 1 site in Italy.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 15 Jun 2006. 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 Italy. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00337324, which also lists 2 linked publications.
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 15 Jun 2006.