Diabetic Neuropathy PeripheralRELIEFNCT03455543
Dual Field PEMF Therapy in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy
A study testing Active Provant Therapy System in people with Diabetic Neuropathy Peripheral, run by Regenesis Biomedical, Inc. at 18 sites in United States.
Trial summary
Part A of this trial is a multi-center, prospective, double-blinded, sham-controlled, randomized clinical trial. Part A will evaluate PEMF treatment compared to sham treatment in patients with painful diabetic distal symmetric peripheral neuropathy (DSPN) when treatment is administered 30 minutes twice daily through a… Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Diabetic Neuropathy Peripheral
- What is being tested?
- Active Provant Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 18 sitesUnited States
- Study dates
- 26 Mar 2018to 18 Jul 2019
- 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
- Type 1 or Type 2 diabetes
- Pain attributed to symmetrical lower extremity diabetic peripheral neuropathy for at least 6 months
- DPN pain over the preceding 24 hours is ≥4 and <9 based on the 11-point NPRS (0-10)
- 22 to 80 years of age
- On stable diabetes treatment
- HbA1c less than or equal to 10%
Show all 13Show fewer
- No recent changes to analgesic prescriptions
- ABI of ≥0.8 to ≤1.3
- Walks independently
- Willing and able to give consent
- If female, must be post-menopausal, surgically sterile, abstinent or practicing an effective method of birth control
- Can access an internet browser or smart phone
- To be randomized after the 14-day run-in period, average pain (NPRS) must be ≥ 4 and < 9 over preceding 7 days and subject must be 70% compliant with ePRO assessments (electronic diary)
Who cannot join
- Active, open ulcer on either extremity
- Significant peripheral vascular disease
- Venous insufficiency
- History of solid organ transplant or severe renal disease
- Diagnosed with a non-diabetic cause of chronic neuropathy
- Previous or current history of primary or tertiary hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency, Hepatitis B or C, or HIV infection
Show all 25Show fewer
- Significant cardiovascular disease
- Uncontrolled medical illness
- Requires or anticipates the need for surgery during the study
- Total foot depth of >8 cm
- Has received any investigational drug or device within 30 days
- Has used systemic corticosteroids within 3 months
- History of malignancy within 5 years in treatment area
- A psychiatric disorder of sufficient severity
- Receiving prn narcotic medications
- History of drug or alcohol abuse within 1 year
- Implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s0
- Pregnant or planning to become pregnant
- Previous treatment with Provant Therapy
- Unwilling to follow instructions or comply with study instructions
- Pain from any other source that could confuse DPN pain assessment
- Clinically significant foot deformity
- Skin condition that could alter peripheral sensations
- Previous surgery to the spine or lower extremity with residual symptoms of pain or difficulty with movement.
- Clinically significant arthropathy
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
River Birch Research Alliance, LLC
Blue Ridge, Georgia, 30514
Wake Family Medicine, PC
Cary, North Carolina, 27513
Mountain View Clinical Research
Denver, Colorado, 80209
Lake Internal Medicine Associates
Eustis, Florida, 32726
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Clinical Physiology Associates
Fort Myers, Florida, 33912
Healthcare Research Network
Hazelwood, Missouri, 63042
The Center for Pharmaceutical Research, LLC
Kansas City, Missouri, 64114
Palm Research Center
Las Vegas, Nevada, 89128
Physician's Research Group
Mesa, Arizona, 85206
Spotlight Research Center
Miami, Florida, 33176
Valley Clinical Research
Northridge, California, 91325
Rainier Clinical Research
Renton, Washington, 98057
Northern California Research
Sacramento, California, 95821
Diabetes Research Center
Tustin, California, 92780
Great Lakes Medical Resarch
Westfield, New York, 14787
Heartland Research Associate, LLC
Wichita, Kansas, 67207
Clinical Research of Central Florida
Winter Haven, Florida, 33880
About this study
Official title: A Multi-Center, Double-Blind, Sham-Controlled, Randomized Trial of Dual Field PEMF Therapy [Provant® Therapy System] in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy (DSPN) (The RELIEF Trial)
Part A of this trial is a multi-center, prospective, double-blinded, sham-controlled, randomized clinical trial. Part A will evaluate PEMF treatment compared to sham treatment in patients with painful diabetic distal symmetric peripheral neuropathy (DSPN) when treatment is administered 30 minutes twice daily through a 120-day period (4 months). Part B is a 8-month open-label active treatment extension period designed to collect longer-term data on pain, medication use, quality of life and safety (Part B).Part B of this trial is a an extension period upon completion of Part A.
Read the detailed description
Eligible subjects will be entered into a 14-day ePRO diary run-in period to collect average baseline pain scores related to their diabetic neuropathy in the lower extremities, diary compliance, and analgesic consumption (maintenance and prn prescribed peripheral neuropathic pain medication pill counts). Subjects will collect electronic patient-reported outcome (ePRO) data each morning around the same time during the run-in period.
Subjects will return to the clinic at Baseline (Day 0) for review of eligibility, diary compliance, average baseline diabetic neuropathic pain score of ≥4 and <9, and review of stable analgesic pain consumption profile during the 14-day run-in period. Qualified subjects based on diary compliance and average pain score will be randomized 1:1 (active: sham) and will be instructed to self-treat twice daily for 120 days. Subjects will record electronic patient-reported outcome (ePRO) data following each morning treatment for 120 days. Subjects consenting to distal thigh and distal leg skin biopsies during the Screening visit will have biopsies collected and sent to the central laboratory for assessment. All subjects will have baseline assessments conducted.
Subjects will receive a telephone call at Day 7 to ensure compliance to treatment and diary completion, provide follow-up information on the biopsy sites (if applicable), complete a blinding assessment as well as be assessed for safety and concomitant medication changes.
At Month 1 subjects will return to the clinic for evaluation of safety, concomitant medication changes, review device usage and ePRO diary completion, and Patient Global Impression (PGI). Treatment satisfaction will also be assessed.
At Month 2 subjects will return to the clinic for evaluation of safety, concomitant medication changes, treatment satisfaction, review of device usage (reports will be supplied to the site) and ePRO diary completion, quality of life outcomes (WPAIQ and NeuroQoL), Patient Global Impression (PGI), and interim visit measurements of SPP.
At Month 3, subjects will return to the clinic for evaluation of safety, concomitant medication changes, review device usage (reports will be supplied to the site) and ePRO diary completion, and Patient Global Impression (PGI). Treatment satisfaction will also be assessed.
At Month 4 (end of Part A / start of Part B), subjects will return to the clinic for evaluation of safety, treatment satisfaction, review of device usage (reports will be supplied to the site), HbA1c, concomitant medication changes, weight, quality of life outcomes (WPAIQ and NeuroQoL), PGI, final measurements of SPP, NCS, QST and be assessed to determine their Toronto Clinical Neuropathy Score. Those subjects who consented and had biopsies collected at the Enrollment visit, will have their end of study biopsies during this visit and samples sent directly to the central laboratory for assessment. Subjects will return the study device and complete a blinding assessment.
Subjects that complete Part A will continue into the open-label extension period (Part B). All subjects will be reconsented if not completed at a prior visit and given an open-label active device. Subjects will record ePRO data for one week prior to the Month 6, 8, 10, and 12 visits following each morning treatment. Subjects will be reminded of the150-day (Month 5) phone call.
At Month 5, subjects will receive a telephone call to ensure compliance to treatment, and to be assessed for safety and concomitant medication changes.
At Month 6, subjects will receive a telephone call to ensure treatment compliance and collection of diary data, and to assess safety and concomitant medication changes.
At Month 7, subjects will receive a telephone call to ensure treatment compliance, and to assess safety and concomitant medication changes.
At Month 8, subjects will return to the clinic for evaluation of safety, measure QST, treatment satisfaction, review of device usage and collection of diary data, concomitant medication changes, quality of life outcomes (NeuroQoL), and PGI.
At Month 9, subjects will receive a telephone call to ensure treatment compliance, and to assess safety and concomitant medication changes.
At Month 10, subjects will receive a telephone call to ensure treatment compliance and collection of diary data, and to assess safety and concomitant medication changes.
At Month 11, subjects will receive a telephone call to ensure treatment compliance, and to assess safety and concomitant medication changes.
At Month 12 (end of open-label treatment extension), subjects will return to the clinic for evaluation of safety, weight, QST, NCS, TCNSS, PGI, treatment satisfaction, review of device usage and collection of diary data, concomitant medication changes, quality of life outcomes (NeuroQoL), and will return the study device. Subjects who consented and had biopsies collected at the 4 Month visit, will have their end of study biopsies performed during this visit.
- Conditions
- Diabetic Neuropathy Peripheral
- Being tested
- Active Provant Therapy System, Inactive (sham) Provant Therapy System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Provant Therapy SystemDevice
Treatment with active Provant Therapy System
Inactive (sham) Provant Therapy SystemDevice
Treatment with inactive Provant Therapy System
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Experimental | Treatment with active Provant Therapy System Receives: Device: Active Provant Therapy System |
| Sham Group | Sham comparator | Treatment with in-active (sham) Provant Therapy System Receives: Device: Inactive (sham) Provant Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain).
Measured: Baseline through 4 months
Secondary outcomes (8)
Patients With 2 Point or 30% Reduction in Pain at 4 Months
Percentage of patients who have either a 2 point or 30% reduction in (pain) NPRS at 4 Months.
Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain).
Measured: Baseline to 4 months
Patient Global Impression at 4 Months
Patient Global Impression at 4 Months. The question assesses change since the start of the study on a 7-point scale ("Since the start of the study, how has your diabetic neuropathy in your legs changed?"), and to score it as either very much worse, much worse, minimally worse, no change, minimally improved, much improved or very much improved.
Measured: Baseline through 4 months.
Time to 30% or 2-point Reduction in NPRS, Whichever Comes First, Through 4 Months
Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain). Number of participants achieving a 30% or 2-point reduction at or prior to weeks 1, 4, 8, 12 and 17 are displayed below.
Measured: Through 4 months
Change in Neuropathy Related Quality of Life (NeuroQoL) Between Baseline and End of Treatment at 4 Months.
A validated set of health-related quality of life measures that are domain specific.Subjects will completed 6 domains: (1) Pain, (2) Lost/Reduced Feeling, (3) Diffuse Sensory Motor Symptoms, (4) Restrictions in Activities of Daily Living, (5) Disruptions in Social Relationships, and (6) Emotional Distress.The short forms were completed by the subject at the Enrollment Visit and end of study visit (Day 121). Each question in the domain was rated on a symptom scale from 1 (never) to 5 (all the time) and a bothersome scale from 1 (none) to 3 (very much).
The total score for the domain was calculated by multiplying the symptom score by the bothersome score. The scale range is from 1 to 15 where the minimum (best/least symptomatic) score is 1 and the maximum (worst/most symptomatic) score is 15. The mean change from Baseline to month 4 is displayed below.
Measured: Baseline to 4 months
Change is Skin Perfusion Pressure (SPP) for Baseline to End of Treatment at 4 Months
SPP was measured at two locations on each foot (dorsal right and left and plantar right and left). Mean change displayed from Baseline to 4-months displayed below.
SPP measures pressure in mmHg; an increase in pressure is favorable.
- Normal SPP: 50 mmHg to 100 mmHg
- Marginal Ischemia SPP: 30 mmHg to 50 mmHg
- Critical Limb Ischemia / PAD SPP: < 30 mmHg
Measured: Baseline to 4 months
Changes in Nerve Conduction Studies of Velocity Between Baseline and End of Treatment at 4 Months.
Using the NC-stat DPNCheck, the sural nerve conduction velocity was recorded on the right and left legs. An increase in velocity would suggest DPN improvement. The mean change from Baseline to 4-months is displayed below.
Measured: Baseline to 4 Months
Changes in Quantitative Sensory Testing (QST) Between Baseline and End of Treatment at 4 Months.
Contact thermal stimulation will be delivered using the Medoc Ltd. Q-Sense system to assess cool sensation threshold, warm sensation threshold and heat pain threshold modalities using the method of limits. Within the cool and warm sensation modalities, the trial is repeated 4 times on each foot and 3 times on each foot for heat pain threshold modality. The cool thermal testing will be conducted prior to the warm and heat pain thermal testing.
Mean change from baseline to 4-months displayed below.
Measured: Baseline to 4 months
Changes in Nerve Conduction Studies of Amplitude Between Baseline and End of Treatment at 4 Months.
Using the NC-stat DPNCheck, the sural nerve conduction amplitude was recorded on the right and left legs. An increase in amplitude would suggest DPN improvement. The mean change from Baseline to 4-months is displayed below.
Measured: Baseline to 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start26 Mar 2018
- Primary completion14 Nov 2018
- Study completion18 Jul 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Neuropathy PeripheralStudies 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
- Model description
- Two parallel groups, active device group versus sham device group. Subjects will be randomized 1:1 at baseline and treat with active PEMF or sham for 4 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 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
- NCT03455543
- Sponsor's protocol ID
- RBI.2017.002
- Acronym
- RELIEF
- Status last verified
- Jul 2020
- First submitted
- 28 Feb 2018
- Last updated
- 15 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tassone EE, Page JC, Slepian MJ. Assessing the Effects of Pulsed Electromagnetic Therapy on Painful Diabetic Distal Symmetric Peripheral Neuropathy: A Double-Blind Randomized Controlled Trial. J Diabetes Sci Technol. 2025 Mar;19(2):361-369. doi: 10.1177/19322968231190413. Epub 2023 Aug 4.
PubMed 37542366
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Sham-Controlled, Randomized Trial of Dual Field PEMF Therapy [Provant® Therapy System] in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy (DSPN) (The RELIEF Trial)
- ClinicalTrials.gov ID
- NCT03455543
- Acronym / sponsor ID
- RELIEF / RBI.2017.002
- Conditions
- Diabetic Neuropathy Peripheral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Regenesis Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Posted 9 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part A of this trial is a multi-center, prospective, double-blinded, sham-controlled, randomized clinical trial. Part A will evaluate PEMF treatment compared to sham treatment in patients with painful diabetic distal symmetric peripheral neuropathy (DSPN) when treatment is administered 30 minutes twice daily through a 120-day period (4 months). Part B is a 8-month open-label active treatment extension period designed to collect longer-term data on pain, medication use, quality of life and safety (Part B).Part B of this trial is a an extension period upon completion of Part A.
Detailed description
Eligible subjects will be entered into a 14-day ePRO diary run-in period to collect average baseline pain scores related to their diabetic neuropathy in the lower extremities, diary compliance, and analgesic consumption (maintenance and prn prescribed peripheral neuropathic pain medication pill counts). Subjects will collect electronic patient-reported outcome (ePRO) data each morning around the same time during the run-in period.
Subjects will return to the clinic at Baseline (Day 0) for review of eligibility, diary compliance, average baseline diabetic neuropathic pain score of ≥4 and <9, and review of stable analgesic pain consumption profile during the 14-day run-in period. Qualified subjects based on diary compliance and average pain score will be randomized 1:1 (active: sham) and will be instructed to self-treat twice daily for 120 days. Subjects will record electronic patient-reported outcome (ePRO) data following each morning treatment for 120 days. Subjects consenting to distal thigh and distal leg skin biopsies during the Screening visit will have biopsies collected and sent to the central laboratory for assessment. All subjects will have baseline assessments conducted.
Subjects will receive a telephone call at Day 7 to ensure compliance to treatment and diary completion, provide follow-up information on the biopsy sites (if applicable), complete a blinding assessment as well as be assessed for safety and concomitant medication changes.
At Month 1 subjects will return to the clinic for evaluation of safety, concomitant medication changes, review device usage and ePRO diary completion, and Patient Global Impression (PGI). Treatment satisfaction will also be assessed.
At Month 2 subjects will return to the clinic for evaluation of safety, concomitant medication changes, treatment satisfaction, review of device usage (reports will be supplied to the site) and ePRO diary completion, quality of life outcomes (WPAIQ and NeuroQoL), Patient Global Impression (PGI), and interim visit measurements of SPP.
At Month 3, subjects will return to the clinic for evaluation of safety, concomitant medication changes, review device usage (reports will be supplied to the site) and ePRO diary completion, and Patient Global Impression (PGI). Treatment satisfaction will also be assessed.
At Month 4 (end of Part A / start of Part B), subjects will return to the clinic for evaluation of safety, treatment satisfaction, review of device usage (reports will be supplied to the site), HbA1c, concomitant medication changes, weight, quality of life outcomes (WPAIQ and NeuroQoL), PGI, final measurements of SPP, NCS, QST and be assessed to determine their Toronto Clinical Neuropathy Score. Those subjects who consented and had biopsies collected at the Enrollment visit, will have their end of study biopsies during this visit and samples sent directly to the central laboratory for assessment. Subjects will return the study device and complete a blinding assessment.
Subjects that complete Part A will continue into the open-label extension period (Part B). All subjects will be reconsented if not completed at a prior visit and given an open-label active device. Subjects will record ePRO data for one week prior to the Month 6, 8, 10, and 12 visits following each morning treatment. Subjects will be reminded of the150-day (Month 5) phone call.
At Month 5, subjects will receive a telephone call to ensure compliance to treatment, and to be assessed for safety and concomitant medication changes.
At Month 6, subjects will receive a telephone call to ensure treatment compliance and collection of diary data, and to assess safety and concomitant medication changes.
At Month 7, subjects will receive a telephone call to ensure treatment compliance, and to assess safety and concomitant medication changes.
At Month 8, subjects will return to the clinic for evaluation of safety, measure QST, treatment satisfaction, review of device usage and collection of diary data, concomitant medication changes, quality of life outcomes (NeuroQoL), and PGI.
At Month 9, subjects will receive a telephone call to ensure treatment compliance, and to assess safety and concomitant medication changes.
At Month 10, subjects will receive a telephone call to ensure treatment compliance and collection of diary data, and to assess safety and concomitant medication changes.
At Month 11, subjects will receive a telephone call to ensure treatment compliance, and to assess safety and concomitant medication changes.
At Month 12 (end of open-label treatment extension), subjects will return to the clinic for evaluation of safety, weight, QST, NCS, TCNSS, PGI, treatment satisfaction, review of device usage and collection of diary data, concomitant medication changes, quality of life outcomes (NeuroQoL), and will return the study device. Subjects who consented and had biopsies collected at the 4 Month visit, will have their end of study biopsies performed during this visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups, active device group versus sham device group. Subjects will be randomized 1:1 at baseline and treat with active PEMF or sham for 4 months.
| Arm | Type | Receives |
|---|---|---|
| Active Group | Experimental | Device: Active Provant Therapy SystemTreatment with active Provant Therapy System |
| Sham Group | Sham comparator | Device: Inactive (sham) Provant Therapy SystemTreatment with in-active (sham) Provant Therapy System |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Type 1 or Type 2 diabetes
- Pain attributed to symmetrical lower extremity diabetic peripheral neuropathy for at least 6 months
- DPN pain over the preceding 24 hours is ≥4 and <9 based on the 11-point NPRS (0-10)
- 22 to 80 years of age
- On stable diabetes treatment
Key exclusion criteria (25 listed)
- Active, open ulcer on either extremity
- Significant peripheral vascular disease
- Venous insufficiency
- History of solid organ transplant or severe renal disease
- Diagnosed with a non-diabetic cause of chronic neuropathy
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 |
|---|---|---|
| Active Provant Therapy SystemTreatment with active Provant Therapy System | Device | Active Group |
| Inactive (sham) Provant Therapy SystemTreatment with inactive Provant Therapy System | Device | Sham Group |
Primary outcome
Change in Pain Intensity
Time frame: Baseline through 4 months
Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain).
8 secondary outcomes
Patients With 2 Point or 30% Reduction in Pain at 4 Months
Time frame: Baseline to 4 months
Patient Global Impression at 4 Months
Time frame: Baseline through 4 months.
Time to 30% or 2-point Reduction in NPRS, Whichever Comes First, Through 4 Months
Time frame: Through 4 months
Change in Neuropathy Related Quality of Life (NeuroQoL) Between Baseline and End of Treatment at 4 Months.
Time frame: Baseline to 4 months
Change is Skin Perfusion Pressure (SPP) for Baseline to End of Treatment at 4 Months
Time frame: Baseline to 4 months
Changes in Nerve Conduction Studies of Velocity Between Baseline and End of Treatment at 4 Months.
Time frame: Baseline to 4 Months
Changes in Quantitative Sensory Testing (QST) Between Baseline and End of Treatment at 4 Months.
Time frame: Baseline to 4 months
Changes in Nerve Conduction Studies of Amplitude Between Baseline and End of Treatment at 4 Months.
Time frame: Baseline to 4 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37542366Tassone EE, Page JC, Slepian MJ. Assessing the Effects of Pulsed Electromagnetic Therapy on Painful Diabetic Distal Symmetric Peripheral Neuropathy: A Double-Blind Randomized Controlled Trial. J Diabetes Sci Technol. 2025 Mar;19(2):361-369. doi: 10.1177/19322968231190413. Epub 2023 Aug 4.
- 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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Provant Therapy System in people with Diabetic Neuropathy Peripheral, run by Regenesis Biomedical, Inc. at 18 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 13 inclusion and 25 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 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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. Some participants in this study may receive a placebo. 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 9 Mar 2020). 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?
Change in Pain Intensity (time frame: Baseline through 4 months). 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 NCT03455543, which also lists 1 linked publication.
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 Jul 2020.