Painful Peripheral Diabetic NeuropathyNCT02696070
Nociceptive Pain Fiber Response
A study testing Provant Therapy System in people with Painful Peripheral Diabetic Neuropathy, run by Regenesis Biomedical, Inc. at 1 site in United States.
Trial summary
This study is designed to evaluate the effectiveness of the Provant Therapy System in improving localized nerve growth and skin perfusion in subjects with painful peripheral diabetic neuropathy of the foot. Read more about this study
- Who is it for?
- Ages 22 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Painful Peripheral Diabetic Neuropathy
- What is being tested?
- Provant Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 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
- Healthy volunteers accepted
- 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 has an HgbA1c > 7% and < 10%.
- Subject has peripheral diabetic neuropathy with pain, numbness, tingling, and/or burning in at least one foot confirmed by a positive provocative sign and a positive Tinel's sign. If both feet are involved, the one with the greatest severity will be selected as the index foot.
- Subject is in pain Phase 2, 3, or 4 (Appendix C).
- Subject is willing and able to give written informed consent and to comply with all parts of the study protocol including diary entries.
- 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).
Who cannot join
- Subject has Type 1 diabetes.
- Subject is in pain Phase 1 or 5 (Appendix C).
- 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 >1.40 or < 0.80. See Appendix E for details on obtaining the ABI.
- NOTE: If the difference in the brachial pulse pressure between the right and left arms is > 10 mmHg, the subject will not be eligible for enrollment and will be referred to a cardiologist for further evaluation.
- Subject has venous insufficiency classified by the Venous Insufficiency Classification System (CEAP) of grades C3, C4, C5, or C6. See Appendix F for description of the venous insufficiency grading.
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- Subject has undergone decompression surgery on the index foot to treat peripheral neuropathy within 2 years of the Screening Visit.
- Subject requires or anticipates the need for surgery of any type during the 60 day treatment period.
- Subject is a smoker or has been a smoker within one year of the Screening Visit.
- Subject has a total foot thickness (plantar surface to mid-dorsal surface) of > 6 centimeters.
- Subject anticipates travelling over the course of the 60 day treatment period.
- 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 undergone any local injection into the index foot within 30 days prior to the Screening Visit or within 6 weeks prior to the Screening Visit for long acting lidocaine injection products.
- Subject has used systemic corticosteroids within 2 months of the Screening Visit.
- Subject has a history of any uncontrolled medical illness that in the investigator's judgment places the subject at unacceptable risk for receipt of PEMF therapy.
- Subject has a history of malignancy within the past five years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area and/or localized in situ carcinoma of the cervix.
- Subject has a serious psychosocial co-morbidity.
- Subject has a history of drug or alcohol abuse, as confirmed by urine drug screen, 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 or planning on becoming pregnant prior to Day 60.
- Subject has been previously treated with the PROVANT Therapy System.
- Subject is unwilling or unable to follow study instructions, or comply with the treatment regimen and study visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center, Randomized, Sham-Controlled, Double-Blind Study of Pulsed Electromagnetic Field (PEMF) Therapy to Evaluate Small Fiber Nerve Growth and Function in Subjects With Painful Peripheral Diabetic Neuropathy
This study is designed to evaluate the effectiveness of the Provant Therapy System in improving localized nerve growth and skin perfusion in subjects with painful peripheral diabetic neuropathy of the foot.
Read the detailed description
The study is multi-site, randomized, double-blind, sham-controlled study of the safety and efficacy of multi-dose Provant therapy to evaluate neuronal and vascular response in the treatment of subjects with painful peripheral diabetic neuropathy. Subjects will be randomized in a 2:1 ratio to receive therapy with an active device or an identical inactive sham device. Subjects will treat at home twice daily for 60 days after which they will return to the clinic for final evaluations. Subjects will be evaluated at the research center for a Baseline/Enrollment visit and again at Day 61 where assessments for safety, concomitant medications, Sympathetic Skin Response (SSR), Nerve Conduction Velocity (NCV), Skin Perfusion Pressures (SPP), and Skin Biopsy will be completed. Subjects will be contacted via telephone at Day 14, Day 28 and Day 42 to assess adherence, safety, and concomitant medications. Subjects will also complete a Response to Study Device form which will capture their daily pain score.
- Conditions
- Painful Peripheral Diabetic Neuropathy
- Being tested
- Provant Therapy System
- Keywords
- Pain, Diabetic Neuropathy, Pulsed Electromagnetic Energy Field, PEMF, PPDN
- Medical subject headings
- Pain, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provant Therapy SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Sham of Provant | Other | Sham of Provant Receives: Device: Provant Therapy System |
| Active Treatment | Other | Active Provant Treatment Receives: Device: Provant Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Small Nerve Fiber Density by Assessment of a Skin Biopsy Comparing Baseline to Day 60
The mean percent change in intraepidermal nerve fiber density mean values for mean nerve fibers per millimeter squared from baseline to Day 60 was calculated for each treatment group (value at 60 days minus value at baseline).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 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
- NCT02696070
- Sponsor's protocol ID
- RBI.2015.002
- Status last verified
- Dec 2016
- First submitted
- 17 Feb 2016
- Last updated
- 12 Jan 2018
- 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 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Sham-Controlled, Double-Blind Study of Pulsed Electromagnetic Field (PEMF) Therapy to Evaluate Small Fiber Nerve Growth and Function in Subjects With Painful Peripheral Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT02696070
- Acronym / sponsor ID
- RBI.2015.002
- Conditions
- Painful Peripheral Diabetic Neuropathy
- Keywords
- Pain, Diabetic Neuropathy, Pulsed Electromagnetic Energy Field, PEMF, PPDN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Regenesis Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Posted 12 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the effectiveness of the Provant Therapy System in improving localized nerve growth and skin perfusion in subjects with painful peripheral diabetic neuropathy of the foot.
Detailed description
The study is multi-site, randomized, double-blind, sham-controlled study of the safety and efficacy of multi-dose Provant therapy to evaluate neuronal and vascular response in the treatment of subjects with painful peripheral diabetic neuropathy. Subjects will be randomized in a 2:1 ratio to receive therapy with an active device or an identical inactive sham device. Subjects will treat at home twice daily for 60 days after which they will return to the clinic for final evaluations. Subjects will be evaluated at the research center for a Baseline/Enrollment visit and again at Day 61 where assessments for safety, concomitant medications, Sympathetic Skin Response (SSR), Nerve Conduction Velocity (NCV), Skin Perfusion Pressures (SPP), and Skin Biopsy will be completed. Subjects will be contacted via telephone at Day 14, Day 28 and Day 42 to assess adherence, safety, and concomitant medications. Subjects will also complete a Response to Study Device form which will capture their daily pain score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham of Provant | Other | Device: Provant Therapy SystemSham of Provant |
| Active Treatment | Other | Device: Provant Therapy SystemActive Provant Treatment |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 has an HgbA1c > 7% and < 10%.
- Subject has peripheral diabetic neuropathy with pain, numbness, tingling, and/or burning in at least one foot confirmed by a positive provocative sign and a positive Tinel's sign. If both feet are involved, the one with the greatest severity will be selected as the index foot.
- Subject is in pain Phase 2, 3, or 4 (Appendix C).
Key exclusion criteria (22 listed)
- Subject has Type 1 diabetes.
- Subject is in pain Phase 1 or 5 (Appendix C).
- 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 >1.40 or < 0.80. See Appendix E for details on obtaining the ABI.
- NOTE: If the difference in the brachial pulse pressure between the right and left arms is > 10 mmHg, the subject will not be eligible for enrollment and will be referred to a cardiologist for further evaluation.
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 Therapy System | Device | Active Treatment, Sham of Provant |
Primary outcome
Changes in Small Nerve Fiber Density by Assessment of a Skin Biopsy Comparing Baseline to Day 60
Time frame: 60 days
The mean percent change in intraepidermal nerve fiber density mean values for mean nerve fibers per millimeter squared from baseline to Day 60 was calculated for each treatment group (value at 60 days minus value at baseline).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Painful Peripheral Diabetic Neuropathy
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Recruiting
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
RecruitingPhase 3
Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathic Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provant Therapy System in people with Painful Peripheral Diabetic Neuropathy, run by Regenesis Biomedical, Inc. 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 7 inclusion and 22 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 12 Jan 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2018). 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?
Changes in Small Nerve Fiber Density by Assessment of a Skin Biopsy Comparing Baseline to Day 60 (time frame: 60 days). 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 12 Jan 2018.