Diabetic Peripheral NeuropathyNCT03077893
Study of PEMF to Evaluate VPT and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy
A study testing Active Provant Therapy System in people with Diabetic Peripheral Neuropathy, run by Regenesis Biomedical, Inc. at 1 site in United States.
Trial summary
A study to demonstrate the effectiveness of PEMF treatment compared to sham treatment in changing Vibration Perception Threshold (VPT) and Thermal Sensory (QST) in patients with diabetic peripheral neuropathy (DPN) when treatment is administered twice daily through 120-day period. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- 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
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2017to 26 Dec 2017
- 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 1 or Type 2 diabetes mellitus (receiving insulin, diet controlled, or taking parenteral hypoglycemic agents)
- Subject is on a stable antidiabetic regimen (medication and/or diet) to control their diabetes for at least 30 days prior to Screening.
- Subject has an HbA1c <10% at Screening or within 2 months of Screening.
- Subject has daily pain attributed to bilateral symmetrical Diabetic Peripheral Neuropathy with numbness, tingling, and/or burning based on clinical judgement for at least 6 months prior to screening.
- Subject's pain or discomfort from DPN is identifiable.
Show all 12Show fewer
- Subject is in pain Phase 2, 3, or 4 as per the Phasing of Neuropathy Scale.
- Subjects average pain over the last 24 hours is ≥3 based on the 11-point Numeric Pain Rating Scale (NPRS) at the Screening Visit.
- Subject has adequate lower extremity pulse in both feet and no intermittent claudication.
- Subject is able to ambulate independently without assistive devices.
- 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 agrees 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 is in pain Phase 1 or 5 as per the Phasing of Neuropathy Scale.
- Subject has an active, open ulcer on the lower extremities.
- Subject has peripheral vascular disease defined as absence of more than one foot pulse per foot and/or ABI <0.8 and >1.4 and/or history of angioplasty or peripheral bypass surgery within 6 months of the Screening Visit.
- Subject has venous insufficiency as classified by the Venous Insufficiency Classification System of grade C6.
- Subject has undergone nerve decompression surgery on the lower extremities.
- Subject has a history of previous kidney, pancreas, cardiac transplantation, or severe renal disease.
Show all 28Show fewer
- Subject has been diagnosed with non-diabetic chronic inflammatory neuropathic disease (e.g. end stage renal disease, hepatitis C, chemotherapy induced neuropathy, known connective tissue disease, systemic lupus).
- Subject has peripheral vascular disease requiring revascularization of lower limb or amputation or evidence of ulcer amputation.
- Subject has clinically significant cardiovascular disease within 6 months prior to screening (unstable or poorly controlled hypertension, transient ischemic attack, MI, unstable angina, arrhythmia, any heart surgery, stent placement, heart disease).
- Subject has a history of any uncontrolled medical illness that in the Investigators judgment places the subject at unacceptable risk for receipt of PEMF therapy.
- Subject requires or anticipates the need for surgery of any type or travel during the treatment period.
- Subject has a total foot depth (most inferior aspect of the medial malleolus to the plantar aspect of the foot when residing on a treatment pad) of >8 cm.
- Subject has received any investigational drug or device 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 3 months of the Screening Visit.
- Subject has a history of malignancy within the past 5 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 121.
- Subject has previously treated with PROVANT® Therapy System within 60 days on the lower extremity.
- Subject is unwilling or unable to follow study instructions or comply with the treatment regimen, diary documentation, and study visits.
- Subject has pain from any other source that can confuse the assessment of the pain associated with DPN.
- Subject has a clinically significant foot deformity (Charcot's syndrome or club foot).
- Subject has received nerve blocks for neuropathic pain within 4 weeks of the Screening Visit.
- Subject has been diagnosed with mononeuropathy.
- Subject has a skin condition that could alter their sensation.
- Subject has had a previous surgery to the spine or lower extremity with residual symptoms of pain or difficulty with movement.
- Subject has moderate or severe arthropathy (RA, OA, Gout) that causes discomfort during casual walking or stair climbing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, 85015
About this study
Official title: A Multi-Center, Sham-Controlled, Double-Blind Randomized Withdrawal Study of PEMF Therapy to Evaluate Vibration Perception Threshold and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy in the Lower Extremity
A study to demonstrate the effectiveness of PEMF treatment compared to sham treatment in changing Vibration Perception Threshold (VPT) and Thermal Sensory (QST) in patients with diabetic peripheral neuropathy (DPN) when treatment is administered twice daily through 120-day period.
Read the detailed description
Multi-center, sham-controlled, double-blind, enriched enrollment, randomized withdrawal clinical trial conducted on subjects with bilateral symmetrical diabetic peripheral neuropathy. Eligible subjects will include those between 22 and 80 years of age with Type 1 or Type 2 diabetes having persistent pain, numbness, tingling, or burning in both feet despite treatment. Eligible subjects will receive two active treatment devices (one for each foot, to allow simultaneous treatment) and treat at home, twice daily for 60 days after which they will return to the clinic at Day 61 for a response assessment. Subjects that are determined to be responders at Day 61 (subjects that achieve a 1-point decrease in the average pain score over the last 24 hours using the Numeric Pain Rating Scale (NPRS)) will be randomized 1:1 to either active treatment or inactive sham devices and will continue treating through Day 120. Subjects that are determined to be non-responders at Day 61 will continue treating with the active devices given at enrollment and will return to the clinic at Day 75 and Day 91 for a response assessment. If a subject is determined to be a responder at Day 75, they will be randomized 1:1 to receive either active treatment or inactive sham and will continue treating through Day 120. If a subject is determined to be a responder at Day 91, they will be randomized 1:1 to receive either active treatment or sham and will continue to treat through Day 120. If a subject continues to be a non-responder at Day 91 they will be terminated from the study.
- Conditions
- Diabetic Peripheral Neuropathy
- 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 (sham) 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 Inactive (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.
Vibration Perception Threshold (VPT)
A non-invasive test used in quantifying sensation/sensitivity to vibration in evaluating sensory dysfunction associated with diabetic neuropathy
Measured: Baseline to End of Treatment (Day 121)
Quantitative Sensory Testing (QST)
QST is a noninvasive test used in peripheral nervous system disorders for thermal sensory testing.
Measured: Baseline to End of Treatment (Day 121)
Secondary outcomes (9)
Nerve Conduction Velocity (NCV) - Velocity
NC-stat® DPNCheck® will be used to record NCV at Baseline and Day 121. Outcome Measure Data table displays change in NCV from Baseline to Day 121.
Measured: The sural nerve conduction velocity will be recorded at the Enrollment Visit and end of study visit (Day 121).
Skin Perfusion Pressures (SPP)
The Vasamed Sensilase PAD-IQ will be used to record SPP. This machine measures pressure (in mm Hg) of microcirculation using a laser Doppler sensor. Outcome Measure Data Table below displays change from Baseline to Day 121.
Measured: SPP will be conducted at the Enrollment Visit, Day 61, and end of study visit (Day 121).
Pain Intensity (PI)
Mean change from Baseline to Day 121, using a validated 11-point Numeric Pain Rating Scale (NPRS) with scores 0-10, where 0 = no pain and 10 = worst possible pain.
Measured: Collected as patient-reported outcomes on a paper diary and at the Enrollment visit to obtain a baseline value and on Days 61, 75, and 91
Brief Pain Inventory (BPI); Question on Pain Right Now.
The BPI long form will be administered at the Enrollment Visit, Day 30, 61, 91, and end of study visit (Day 121). Results for question #15 on Pain Right Now displayed below. Subject were asked to rate pain right now on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Measured: Change in BPI, pain right now question, from Baseline to Day 121.
Brief Fatigue Inventory (BFI)
A 4-question assessment that assesses the level of fatigue and the impact of the fatigue on daily function over the last 24 hours. BFI is patient reported and collected at the Enrollment Visit, Days 30, 61, 91, and end of study visit (Day 121). A global fatigue score was calculated by averaging all of the values on the questionnaire and results for the change from Baseline to Day 121 are displayed below. The scale ranged from 0 (no fatigue/does not interfere) to 10 (as bad as you can imagine/completely interferes).
Measured: Change from Baseline to Day 121 in BFI.
Patient Global Impression of Change (PGIC)
A 7-choice validated categorical scale of overall change in status since initiation of treatment with the study device.PGIC was collected every 7 days in the paper diary, immediately following the morning treatment. Subjects were asked: Since the start of the study, my overall status is? Choices on the scale included: Very much worse, much worse, minimally worse, no change, minimally improved, much improved and very much improved.
Measured: PGIC results at Day 121 displayed below.
Hospital Anxiety and Depression Scale (HADS)
A patient reported 14 question assessment that detects the status of depression and anxiety. Subjects completed the assessment at the Enrollment Visit, Days 30, 61, 91, and end of study visit (Day 121). The total score for anxiety and the total score for depression was calculated at Day 121. Low scores represent normal (0-7) while high scores represent abnormal (11-21).
Measured: Change in Depression and Anxiety from Baseline to Day 121.
Neuro-QoL
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.
Measured: Change in each domain from Baseline to Day 121 is displayed below.
Nerve Conduction Velocity (NCV) - Amplitude
NC-stat® DPNCheck® will be used to record NCV at Baseline and Day 121. Outcome Measure Data table displays change in NCV from Baseline to Day 121.
Measured: The sural nerve conduction amplitude will be recorded at the Enrollment Visit and end of study visit (Day 121).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start9 Mar 2017
- Primary completion26 Dec 2017
- Study completion26 Dec 2017
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects deemed "responders" after active treatment will be randomized in a 1:1 ratio to either active treatment or a sham device.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenesis Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur Tallas, DPM, Principal investigator, Associated Foot & Ankle Specialists, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077893
- Sponsor's protocol ID
- RBI.2017.001
- Status last verified
- May 2019
- First submitted
- 28 Feb 2017
- Last updated
- 30 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Sham-Controlled, Double-Blind Randomized Withdrawal Study of PEMF Therapy to Evaluate Vibration Perception Threshold and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy in the Lower Extremity
- ClinicalTrials.gov ID
- NCT03077893
- Acronym / sponsor ID
- RBI.2017.001
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Regenesis Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 26 Dec 2017 (actual)
- Study completion
- 26 Dec 2017 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Posted 30 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to demonstrate the effectiveness of PEMF treatment compared to sham treatment in changing Vibration Perception Threshold (VPT) and Thermal Sensory (QST) in patients with diabetic peripheral neuropathy (DPN) when treatment is administered twice daily through 120-day period.
Detailed description
Multi-center, sham-controlled, double-blind, enriched enrollment, randomized withdrawal clinical trial conducted on subjects with bilateral symmetrical diabetic peripheral neuropathy. Eligible subjects will include those between 22 and 80 years of age with Type 1 or Type 2 diabetes having persistent pain, numbness, tingling, or burning in both feet despite treatment. Eligible subjects will receive two active treatment devices (one for each foot, to allow simultaneous treatment) and treat at home, twice daily for 60 days after which they will return to the clinic at Day 61 for a response assessment. Subjects that are determined to be responders at Day 61 (subjects that achieve a 1-point decrease in the average pain score over the last 24 hours using the Numeric Pain Rating Scale (NPRS)) will be randomized 1:1 to either active treatment or inactive sham devices and will continue treating through Day 120. Subjects that are determined to be non-responders at Day 61 will continue treating with the active devices given at enrollment and will return to the clinic at Day 75 and Day 91 for a response assessment. If a subject is determined to be a responder at Day 75, they will be randomized 1:1 to receive either active treatment or inactive sham and will continue treating through Day 120. If a subject is determined to be a responder at Day 91, they will be randomized 1:1 to receive either active treatment or sham and will continue to treat through Day 120. If a subject continues to be a non-responder at Day 91 they will be terminated from the study.
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
- Subjects deemed "responders" after active treatment will be randomized in a 1:1 ratio to either active treatment or a sham device.
| 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 Inactive (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 (12 listed)
- Subject age is greater than or equal to 22 years and less than 80 years of age.
- Subject has documented Type 1 or Type 2 diabetes mellitus (receiving insulin, diet controlled, or taking parenteral hypoglycemic agents)
- Subject is on a stable antidiabetic regimen (medication and/or diet) to control their diabetes for at least 30 days prior to Screening.
- Subject has an HbA1c <10% at Screening or within 2 months of Screening.
- Subject has daily pain attributed to bilateral symmetrical Diabetic Peripheral Neuropathy with numbness, tingling, and/or burning based on clinical judgement for at least 6 months prior to screening.
Key exclusion criteria (28 listed)
- Subject is in pain Phase 1 or 5 as per the Phasing of Neuropathy Scale.
- Subject has an active, open ulcer on the lower extremities.
- Subject has peripheral vascular disease defined as absence of more than one foot pulse per foot and/or ABI <0.8 and >1.4 and/or history of angioplasty or peripheral bypass surgery within 6 months of the Screening Visit.
- Subject has venous insufficiency as classified by the Venous Insufficiency Classification System of grade C6.
- Subject has undergone nerve decompression surgery on the lower extremities.
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 (sham) Provant Therapy System | Device | Sham Group |
Primary outcome
Vibration Perception Threshold (VPT)
Time frame: Baseline to End of Treatment (Day 121)
A non-invasive test used in quantifying sensation/sensitivity to vibration in evaluating sensory dysfunction associated with diabetic neuropathy
Quantitative Sensory Testing (QST)
Time frame: Baseline to End of Treatment (Day 121)
QST is a noninvasive test used in peripheral nervous system disorders for thermal sensory testing.
9 secondary outcomes
Nerve Conduction Velocity (NCV) - Velocity
Time frame: The sural nerve conduction velocity will be recorded at the Enrollment Visit and end of study visit (Day 121).
Skin Perfusion Pressures (SPP)
Time frame: SPP will be conducted at the Enrollment Visit, Day 61, and end of study visit (Day 121).
Pain Intensity (PI)
Time frame: Collected as patient-reported outcomes on a paper diary and at the Enrollment visit to obtain a baseline value and on Days 61, 75, and 91
Brief Pain Inventory (BPI); Question on Pain Right Now.
Time frame: Change in BPI, pain right now question, from Baseline to Day 121.
Brief Fatigue Inventory (BFI)
Time frame: Change from Baseline to Day 121 in BFI.
Patient Global Impression of Change (PGIC)
Time frame: PGIC results at Day 121 displayed below.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change in Depression and Anxiety from Baseline to Day 121.
Neuro-QoL
Time frame: Change in each domain from Baseline to Day 121 is displayed below.
Nerve Conduction Velocity (NCV) - Amplitude
Time frame: The sural nerve conduction amplitude will be recorded at the Enrollment Visit and end of study visit (Day 121).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Diabetic Peripheral Neuropathy
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
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.
Arthur Tallas, DPM principal investigator
Associated Foot & Ankle Specialists, LLC
1 site 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 Peripheral 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 12 inclusion and 28 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 30 Jul 2019. 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. 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 30 Jul 2019). 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?
Vibration Perception Threshold (VPT) (time frame: Baseline to End of Treatment (Day 121)). 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 30 Jul 2019.