Diabetic Peripheral NeuropathyPhase 4DPNNCT00614341
Effect of Pulsing Electrical Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
A Phase 4 study testing MedRelief SE 55 in people with Diabetic Peripheral Neuropathy, run by MedRelief at 1 site in United States.
Trial summary
To determine if pulsed electric field therapy reduces lower leg and foot pain associated with diabetic neuropathy and lessens the need for medication. The MedRelief device sends a sub-threshold electric signal through the skin using electrodes as means of signal delivery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- MedRelief SE 55
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jan 2008
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently diagnosed with diabetes mellitus
- confirmed diagnosis of diabetic peripheral neuropathy
- age 18 years to 75 years
- both males and females are eligible for study participation
- HgA1c level under 9
- Physician confirmed stable glycemic control for 3 months prior to enrollment
Show all 9Show fewer
- baseline pain level over previous month of 5
- willing to sign IRB approved consent and follow study visit requirements
- if female of childbearing age willing to undergo urine pregnancy test
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Nephrology and Rheumatology Associates
Augusta, Georgia, 30909
About this study
Official title: A Phase IV Clinical Trial. Effect of Pulsing Electromagnetic Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
To determine if pulsed electric field therapy reduces lower leg and foot pain associated with diabetic neuropathy and lessens the need for medication.
The MedRelief device sends a sub-threshold electric signal through the skin using electrodes as means of signal delivery. The signal or waveform, frequency and strength were created to match the characteristics of signals the body generates to help natural healing.
Read the detailed description
A multi-center, randomized, open-label study involving 23 patients with chronic diabetic peripheral neuropathy meeting study entry criteria. Subjects will be randomly assigned to receive one of two treatments using an FDA cleared MedRelief device: (1) a MedRelief SE 55 device set on "pulsed" mode at 10 microsecond burst intervals 4150 Ha, or (2) a MedRelief SE 55 device set on "continuous" mode at 4150 Hz. Subjects will wear the device on target foot each night for a minimum of 6 hours over a two week (15 day treatment)period.
Subjects will complete a daily pain diary, medication form, and device use form. Subject global assessments and physician global assessments will occur at baseline, study visits Day 7, Day 15 and Day 21 (end of study).
Response to therapy will include pain reduction, improvement in sensation, improved response to vibratory stimulation and reduction of edema in study subjects.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- MedRelief SE 55
- Keywords
- diabetes mellitus, neuropathy, distal symmetric polyneuropathy, pulsed electric fild
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedRelief SE 55Device
4150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase
| Study group | Role | What they receive |
|---|---|---|
| 1, 2 | Active comparator | 1. Pulse MedRelief SE 55
2. Continuous MedRelief SE 55 Receives: Device: MedRelief SE 55 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction in diabetic patients with chronic diabetic neuropathy
Measured: Day 21
Secondary outcomes (1)
Improvement in sensation and overall foot condition
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startMay 2006
- Primary completionDec 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedRelief
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Amy M Sprague, MD, Principal investigator, Nephrology and Rheumatology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614341
- Sponsor's protocol ID
- 600-001
- Acronym
- DPN
- Status last verified
- Jan 2008
- First submitted
- 30 Jan 2008
- Last updated
- 13 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Clinical Trial. Effect of Pulsing Electromagnetic Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
- ClinicalTrials.gov ID
- NCT00614341
- Acronym / sponsor ID
- DPN / 600-001
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- diabetes mellitus, neuropathy, distal symmetric polyneuropathy, pulsed electric fild
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- MedReliefIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 13 Feb 2008 (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.
To determine if pulsed electric field therapy reduces lower leg and foot pain associated with diabetic neuropathy and lessens the need for medication.
The MedRelief device sends a sub-threshold electric signal through the skin using electrodes as means of signal delivery. The signal or waveform, frequency and strength were created to match the characteristics of signals the body generates to help natural healing.
Detailed description
A multi-center, randomized, open-label study involving 23 patients with chronic diabetic peripheral neuropathy meeting study entry criteria. Subjects will be randomly assigned to receive one of two treatments using an FDA cleared MedRelief device: (1) a MedRelief SE 55 device set on "pulsed" mode at 10 microsecond burst intervals 4150 Ha, or (2) a MedRelief SE 55 device set on "continuous" mode at 4150 Hz. Subjects will wear the device on target foot each night for a minimum of 6 hours over a two week (15 day treatment)period.
Subjects will complete a daily pain diary, medication form, and device use form. Subject global assessments and physician global assessments will occur at baseline, study visits Day 7, Day 15 and Day 21 (end of study).
Response to therapy will include pain reduction, improvement in sensation, improved response to vibratory stimulation and reduction of edema in study subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1, 2 | Active comparator | Device: MedRelief SE 551. Pulse MedRelief SE 55 2. Continuous MedRelief SE 55 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- currently diagnosed with diabetes mellitus
- confirmed diagnosis of diabetic peripheral neuropathy
- age 18 years to 75 years
- both males and females are eligible for study participation
- HgA1c level under 9
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| MedRelief SE 554150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase | Device | 1, 2 |
Primary outcome
Pain reduction in diabetic patients with chronic diabetic neuropathy
Time frame: Day 21
1 secondary outcome
Improvement in sensation and overall foot condition
Time frame: Day 21
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 13 Feb 2008.
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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.
Amy M Sprague, MD principal investigator
Nephrology and Rheumatology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MedRelief SE 55 in people with Diabetic Peripheral Neuropathy, run by MedRelief at 1 site in United States.
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 9 inclusion and 1 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 13 Feb 2008. 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 United States. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pain reduction in diabetic patients with chronic diabetic neuropathy (time frame: Day 21). 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 Feb 2008.