Painful Peripheral Diabetic NeuropathyNCT02809911
A Study to Evaluate PEMF Therapy on Experimentally Inducted Pain in Subjects With Painful Peripheral Diabetic Neuropathy
A study testing Provant in people with Painful Peripheral Diabetic Neuropathy, run by Regenesis Biomedical, Inc. at 2 sites in United States.
Trial summary
Evaluate the effectiveness of the Provant Therapy System compared to sham on pain sensitivity and nervous system response to various qualities of experimentally induced pain in the upper and lower extremities of subjects with painful peripheral diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Painful Peripheral Diabetic Neuropathy
- What is being tested?
- Provant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject age is greater than or equal to 22 years and less than 80 years of age.
- Subject has documented Type 2 diabetes.
- Subject's BMI ≤ 38.
- Subject has peripheral diabetic neuropathy with pain, numbness, tingling, and/or burning in at least one foot.
- Subject is in pain Phase 2, 3, or 4 (Appendix B).
- Subject is willing to forego smoking during the Enrollment Visit and Visit 3 (Crossover) for 4 hours prior to and through the duration of testing (~5 hours).
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- Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
- Female subjects must be post-menopausal, surgically sterile, abstinent, or practicing (or agree to practice) an effective method of birth control if they are sexually active for the duration of the study. (Effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier methods, and/or male partner sterilization).
- Subject is able to eat in the morning prior to the induced pain tests and provide a meal/snacks for themselves during the day to maintain blood sugar levels.
Who cannot join
- Subject has current pain other than their painful peripheral diabetic neuropathy.
- Subject has a concomitant medical condition that, in the opinion of the investigator, would confound the ability to conduct induced pain testing in the upper and lower extremities.
- Subject has taken prescription opioids for their pain within 30 days of the Screening Visit or 6 weeks of Screening for long acting medications.
- Subject has used topical capsaicin within 30 days of the Screening Visit.
- Subject has Type 1 diabetes.
- Subject is in pain Phase 1 or 5 (Appendix B).
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- Subject has an active, open ulcer on either lower extremity of arterial, venous or mixed disease origin.
- Subject has peripheral arterial disease as determined by an Ankle-Brachial Index (ABI) of <0.5 or > 1.4. See Appendix C for details on obtaining the ABI.
- Subject has venous insufficiency classified by the Venous Insufficiency Classification System (CEAP) of grade C6. See Appendix D for description of the venous insufficiency grading.
- Subject has an unhealed surgery on the legs, feet, arms or hands.
- Subject has smoked within 4 hours of the Screening Visit.
- Subject has received any investigational drug or device within 30 days or 5 half-lives of the drug, whichever is longer, prior to the Screening Visit or is enrolled in another clinical trial.
- Subject has used systemic corticosteroids within 2 months of the Screening Visit.
- Subject has a history of a solid tumor that is not in complete remission for greater than 2 years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area.
- Subject has a serious psychosocial co-morbidity.
- Subject has a self-reported history of drug or alcohol abuse, within one year prior to the Screening Visit.
- Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
- Subject is currently pregnant.
- Subject has been previously treated with the PROVANT Therapy System within 30 days of the Enrollment Visit.
- Subject is unwilling or unable to follow study instructions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sun Research Institute
San Antonio, Texas, 78215
Multi-Phase Trials, LLC
San Antonio, Texas, 78217
About this study
Official title: A Randomized, Sham-Controlled, Double-Blind, Crossover Study to Evaluate PEMF Therapy on Pain Sensitivity to Different Qualities of Experimentally Induced Pain in Subjects With Painful Peripheral Diabetic Neuropathy
Evaluate the effectiveness of the Provant Therapy System compared to sham on pain sensitivity and nervous system response to various qualities of experimentally induced pain in the upper and lower extremities of subjects with painful peripheral diabetic neuropathy.
Read the detailed description
This is a multi-center, randomized, double-blind, sham-controlled crossover clinical trial conducted on subjects with painful peripheral diabetic neuropathy. Eligible subjects will include those between 22 and 80 years of age with Type 2 diabetes having persistent pain, numbness, tingling, and/or burning in at least one foot. Pain threshold, tolerance to thermal stimuli and pressure response to the induced pain stimuli will be measured at three time points using five standardized experimental pain measures: baseline, after a single 30 minute treatment with active PEMF or sham treatment and after a second 30 minute treatment with active PEMF or sham treatment. Eligible subjects with painful peripheral diabetic neuropathy will undergo Diabetic Screening (Nerve Conduction Velocity, Skin Perfusion Pressure, Ankle-Brachial Index, and Vibratory Testing) in the index foot prior to randomization. Following the Diabetic Screening tests, subjects will return to the research center for the Enrollment/Randomization Visit and complete measures of pain by completing the Brief Pain Inventory (BPI) and functional assessments. Subjects will then be randomly assigned to one of the two groups; control (sham) or experimental (active) device by a research assistant blinded to the device status. Patients will also be randomly assigned to the sequence order of experimental induced pain tests. The ischemic pain testing (SMET) will always be conducted last. Patients will return to the research center within 7 days after the Enrollment/Randomization Visit where they will be crossed over to the other treatment assignment and be randomly assigned to the sequence order of experimental induced pain tests on the same extremity as previously randomized.
- Conditions
- Painful Peripheral Diabetic Neuropathy
- Being tested
- Provant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProvantDevice
| Study group | Role | What they receive |
|---|---|---|
| Sham of Provant | Other | Sham of Provant Therapy System Receives: Device: Provant |
| Active Provant | Other | Active Provant Treatment Receives: Device: Provant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli
Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored).
Measured: 4 weeks
Lower Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli
Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored). .
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Painful Peripheral Diabetic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenesis Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809911
- Sponsor's protocol ID
- RBI.2016.002
- Status last verified
- Oct 2016
- First submitted
- 20 Jun 2016
- Last updated
- 31 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham-Controlled, Double-Blind, Crossover Study to Evaluate PEMF Therapy on Pain Sensitivity to Different Qualities of Experimentally Induced Pain in Subjects With Painful Peripheral Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT02809911
- Acronym / sponsor ID
- RBI.2016.002
- Conditions
- Painful Peripheral Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Regenesis Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Posted 13 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the effectiveness of the Provant Therapy System compared to sham on pain sensitivity and nervous system response to various qualities of experimentally induced pain in the upper and lower extremities of subjects with painful peripheral diabetic neuropathy.
Detailed description
This is a multi-center, randomized, double-blind, sham-controlled crossover clinical trial conducted on subjects with painful peripheral diabetic neuropathy. Eligible subjects will include those between 22 and 80 years of age with Type 2 diabetes having persistent pain, numbness, tingling, and/or burning in at least one foot. Pain threshold, tolerance to thermal stimuli and pressure response to the induced pain stimuli will be measured at three time points using five standardized experimental pain measures: baseline, after a single 30 minute treatment with active PEMF or sham treatment and after a second 30 minute treatment with active PEMF or sham treatment. Eligible subjects with painful peripheral diabetic neuropathy will undergo Diabetic Screening (Nerve Conduction Velocity, Skin Perfusion Pressure, Ankle-Brachial Index, and Vibratory Testing) in the index foot prior to randomization. Following the Diabetic Screening tests, subjects will return to the research center for the Enrollment/Randomization Visit and complete measures of pain by completing the Brief Pain Inventory (BPI) and functional assessments. Subjects will then be randomly assigned to one of the two groups; control (sham) or experimental (active) device by a research assistant blinded to the device status. Patients will also be randomly assigned to the sequence order of experimental induced pain tests. The ischemic pain testing (SMET) will always be conducted last. Patients will return to the research center within 7 days after the Enrollment/Randomization Visit where they will be crossed over to the other treatment assignment and be randomly assigned to the sequence order of experimental induced pain tests on the same extremity as previously randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham of Provant | Other | Device: ProvantSham of Provant Therapy System |
| Active Provant | Other | Device: ProvantActive Provant Treatment |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject age is greater than or equal to 22 years and less than 80 years of age.
- Subject has documented Type 2 diabetes.
- Subject's BMI ≤ 38.
- Subject has peripheral diabetic neuropathy with pain, numbness, tingling, and/or burning in at least one foot.
- Subject is in pain Phase 2, 3, or 4 (Appendix B).
Key exclusion criteria (20 listed)
- Subject has current pain other than their painful peripheral diabetic neuropathy.
- Subject has a concomitant medical condition that, in the opinion of the investigator, would confound the ability to conduct induced pain testing in the upper and lower extremities.
- Subject has taken prescription opioids for their pain within 30 days of the Screening Visit or 6 weeks of Screening for long acting medications.
- Subject has used topical capsaicin within 30 days of the Screening Visit.
- Subject has Type 1 diabetes.
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 |
|---|---|---|
| Provant | Device | Active Provant, Sham of Provant |
Primary outcome
Upper Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli
Time frame: 4 weeks
Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored).
Lower Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli
Time frame: 4 weeks
Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored). .
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provant in people with Painful Peripheral Diabetic Neuropathy, run by Regenesis Biomedical, Inc. at 2 sites 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 20 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 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Upper Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 31 Mar 2017.