Painful Diabetic NeuropathyPDN-SENSORYNCT05777317
Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy
A study testing 10 kHz SCS and CMM alone in people with Painful Diabetic Neuropathy, run by Nevro Corp at 2 sites in United States.
Trial summary
The purpose of this post-market study is to evaluate changes in pain and neurological function with high frequency, 10 kHz spinal cord stimulation (SCS) therapy in patients with chronic, intractable lower limb pain associated with diabetic peripheral neuropathy, a condition known as painful diabetic neuropathy (PDN). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- 10 kHz SCS and CMM alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Apr 2023to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has been clinically diagnosed with diabetes, according to the American Diabetes Association guidelines, as well as painful diabetic neuropathy (PDN) of the lower limbs.
- Has pain intensity (over the last 7 days) of ≥5 out of 10 cm on the Visual Analog Scale (VAS) in the lower limbs at both the Enrollment and Baseline Visits.
- Has PDN symptoms that have been present ≥12 months.
- Is currently taking or has tried in the past a gabapentinoid and at least one other class of analgesic with insufficient pain relief or intolerable side effects.
- Has been on a stable analgesic regimen, as determined by the Investigator, for at least 30 days prior to assessing pain intensity as described in inclusion criterion #2.
- Has painful diabetic sensorimotor polyneuropathy confirmed by modified Toronto Clinical Neuropathy Score (mTCNS) >5 at enrollment. The total score must include presence of foot pain (≥1) and sensory exam findings (≥ 2).
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- Has hemoglobin A1c ≤10% as measured at enrollment.
- Is 22 years of age or older at the time of enrollment.
- Is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the study physician.
- Is willing to and capable of giving written informed consent.
- Is willing and able to comply with study-related requirements and procedures and attend all scheduled visits.
Who cannot join
- Has a diagnosis of a lower limb mononeuropathy (e.g., causalgia, tibial or peroneal neuropathies), has had a lower limb amputation other than toes due to diabetes, or has large (≥3 cm) and/or gangrenous ulcers or active infection of the lower limbs.
- Has an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upper limbs due to diabetic neuropathy at enrollment.
- Has a history of glycemia-related hospitalizations or emergency ward visits including ketoacidosis, hyperosmolar state, severe hypoglycemia in the previous 6 months.
- Uses anticoagulants or antiplatelet agents that cannot be temporarily discontinued prior to the procedure.
- Has unstable cardiovascular disease, including untreated cardiac arrhythmias, myocardial infarction within last 12 months, New York Heart Association (NYHA) Functional Class III or IV heart failure.
- Is currently prescribed a daily opioid dosage > 120 mg morphine equivalents.
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- Has a medical condition or diagnosis that is inconsistent with the Senza System guidelines in the Physician's Manual or as per standard clinical practice.
- Has a medical condition or pain in other area(s), not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis, critical limb ischemia due to peripheral vascular disease or small vessel disease).
- Has prior experience with SCS, dorsal root ganglion (DRG) stimulation, peripheral nerve field stimulation (PNfS), or peripheral nerve stimulation (PNS) for chronic intractable pain.
- Has an existing drug pump and/or another active implantable device such as a pacemaker (ok to have an insulin pump or continuous glucose monitor that remains externalized).
- Has a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza System guidelines in the Physician's Manual.
- Has a life expectancy of less than one year.
- Has a local infection at the anticipated surgical entry site or an active systemic infection.
- Is pregnant or plans to become pregnant during the study (participants of child-bearing potential that are sexually active must use a reliable form of birth control).
- Has had within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
- Is concomitantly participating in another interventional clinical study.
- Is involved in an injury claim for study-related chronic pain that is under current litigation.
- Is a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to study-related chronic pain.
- Has a pending or approved worker's compensation claim for study-related chronic pain.
- Has evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome, as determined by the investigator in the last 12 months.
- Has a BMI > 45 at enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Touchstone Interventional Pain Center
Medford, Oregon, 97504
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: PDN-SENSORY: A Multi-Center Randomized Controlled Trial to Evaluate Pain and Neurological Function With 10 kHz SCS in Treatment of Painful Diabetic Neuropathy
The purpose of this post-market study is to evaluate changes in pain and neurological function with high frequency, 10 kHz spinal cord stimulation (SCS) therapy in patients with chronic, intractable lower limb pain associated with diabetic peripheral neuropathy, a condition known as painful diabetic neuropathy (PDN). This is a multi-center, prospective, randomized controlled study to evaluate improvement in pain and neurological function in PDN patients, with neurological function assessed via objective measures. Patients will be randomized to conventional medical management (CMM) or 10 kHz SCS plus CMM.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- 10 kHz SCS, CMM alone
- Keywords
- Diabetic Neuropathy, Spinal Cord Stimulation
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 kHz SCSDevice
Also called Nevro HFX therapy programmed to a frequency of 10 kHz or high frequency, 10 kHz SCS
Spinal cord stimulation programmed to a frequency of 10 kHz
CMM aloneOther
Conventional medical management alone
| Study group | Role | What they receive |
|---|---|---|
| 10 kHz SCS plus CMM | Experimental | Treatment with high frequency, 10 kHz spinal cord stimulation (SCS) in addition to conventional medical management (CMM) Receives: Device: 10 kHz SCS |
| CMM alone | Active comparator | Treatment with conventional medical management (CMM) alone Receives: Other: CMM alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limb pain responder rate
The lower limb pain responder rate is the proportion of subjects who are pain responders, where a responder is defined as having at least 50% reduction in average lower limb pain score from baseline as measured on a 10-cm Visual Analog Scale (VAS, where a higher score indicates greater pain.
Measured: 6 months
Secondary outcomes (10)
Neurological improvement responder rate
The neurological improvement responder rate is the proportion of subjects who are neurological improvement responders, where a responder is defined as having a decrease of at least 3 points, excluding changes in foot pain under symptom scores, as assessed via the modified Toronto Clinical Neuropathy Score (mTCNS). The mTCNS assesses the severity of symptoms and sensory function loss associated with diabetic neuropathy. All symptom and sensory test scores are summed to provide a total mTCNS score for each assessment. The mTCNS has a maximum score of 33, where a higher score indicates greater neuropathy severity.
Measured: 6 months
Lower limb pain responder rate at 3 months
The lower limb pain responder rate is the proportion of subjects who are pain responders, where a responder is defined as having at least 50% reduction in average lower limb pain score from baseline as measured on a 10-cm Visual Analog Scale (VAS), where a higher score indicates greater pain.
Measured: 3 months
Percent change in lower limb pain intensity
Percent change in average lower limb pain intensity from baseline as measured on a 10-cm Visual Analog Scale (VAS), where a higher score indicates greater pain.
Measured: 6 months
Percent change in PSQ-3
Percent change in Pain and Sleep Questionnaire Three-Item Index (PSQ-3) score from baseline. PSQ-3 is a three-item questionnaire to assess the impact of chronic pain on sleep. Each question is answered on a 10-cm Visual Analog Scale (VAS), and the final score is the average of the three responses. A higher score indicates greater impact of chronic pain on sleep.
Measured: 6 months
Average change in EQ-5D-5L index
Average change in EuroQol 5-dimension 5-level (EQ-5D-5L) index score from baseline. EQ-5D-5L measures the subject's health state as assessed in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with 5 levels. The scores on these five dimensions can be presented as a health profile or can be converted to a single number summary called the "index value." A higher index score indicates higher quality of life.
Measured: 6 months
Average change in NeuroQol
Average change in Neuropathy-Specific Quality of Life Questionnaire (NeuroQol) score from baseline. The NeuroQol measures a patient's perception of the impact diabetic peripheral neuropathy and foot ulcers on quality of life. Each question uses a 5-point Likert scale from 1 ("never") to 5 ("all the time") for frequency of symptoms. A higher NeuroQol value indicates greater impact of diabetic neuropathy on quality of life.
Measured: 6 months
Average change in IENF density at the lower calf
Average change in intraepidermal nerve fiber (IENF) density at the lower calf from baseline. IENF is a measure of small nerve fiber density in the skin, with a higher value indicating greater density of nerve fibers.
Measured: 6 months
Average change in mTCNS
Average change in the modified Toronto Clinical Neuropathy Score (mTCNS) from baseline. The mTCNS assesses the severity of symptoms and sensory function loss associated with diabetic neuropathy. All symptom and sensory test scores are summed to provide a total mTCNS score for each assessment. The mTCNS has a maximum score of 33, where a higher score indicates greater severity of neuropathy.
Measured: 6 months
Average change in HbA1c
Average change in hemoglobin A1c (HbA1c) from baseline for patients with type 2 diabetes and HbA1c >= 8.0% at enrollment
Measured: 6 months
Average change in body weight
Average change in body weight from baseline for patients with type 2 diabetes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start24 Apr 2023
- Primary completion13 Mar 2026
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Painful 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevro Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777317
- Sponsor's protocol ID
- CA2022-2 US PDN-Sensory RCT
- Acronym
- PDN-SENSORY
- Status last verified
- Jun 2026
- First submitted
- 8 Mar 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Pop-Busui R, Petersen EA, Levy BL, Tesfaye S, Armstrong DG, Grunberger G, Boulton AJ, Bharara M, Edgar D, Azalde RP, Caraway D. Evaluating pain and neurological function with high frequency 10 kHz spinal cord stimulation in the treatment of painful diabetic neuropathy: design of a multicentre, randomised controlled trial (PDN-Sensory). BMJ Open. 2025 Nov 27;15(11):e101647. doi: 10.1136/bmjopen-2025-101647.
PubMed 41309477
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PDN-SENSORY: A Multi-Center Randomized Controlled Trial to Evaluate Pain and Neurological Function With 10 kHz SCS in Treatment of Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05777317
- Acronym / sponsor ID
- PDN-SENSORY / CA2022-2 US PDN-Sensory RCT
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- Diabetic Neuropathy, Spinal Cord Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Nevro CorpIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this post-market study is to evaluate changes in pain and neurological function with high frequency, 10 kHz spinal cord stimulation (SCS) therapy in patients with chronic, intractable lower limb pain associated with diabetic peripheral neuropathy, a condition known as painful diabetic neuropathy (PDN). This is a multi-center, prospective, randomized controlled study to evaluate improvement in pain and neurological function in PDN patients, with neurological function assessed via objective measures. Patients will be randomized to conventional medical management (CMM) or 10 kHz SCS plus CMM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 kHz SCS plus CMM | Experimental | Device: 10 kHz SCSTreatment with high frequency, 10 kHz spinal cord stimulation (SCS) in addition to conventional medical management (CMM) |
| CMM alone | Active comparator | Other: CMM aloneTreatment with conventional medical management (CMM) alone |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Has been clinically diagnosed with diabetes, according to the American Diabetes Association guidelines, as well as painful diabetic neuropathy (PDN) of the lower limbs.
- Has pain intensity (over the last 7 days) of ≥5 out of 10 cm on the Visual Analog Scale (VAS) in the lower limbs at both the Enrollment and Baseline Visits.
- Has PDN symptoms that have been present ≥12 months.
- Is currently taking or has tried in the past a gabapentinoid and at least one other class of analgesic with insufficient pain relief or intolerable side effects.
- Has been on a stable analgesic regimen, as determined by the Investigator, for at least 30 days prior to assessing pain intensity as described in inclusion criterion #2.
Key exclusion criteria (21 listed)
- Has a diagnosis of a lower limb mononeuropathy (e.g., causalgia, tibial or peroneal neuropathies), has had a lower limb amputation other than toes due to diabetes, or has large (≥3 cm) and/or gangrenous ulcers or active infection of the lower limbs.
- Has an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upper limbs due to diabetic neuropathy at enrollment.
- Has a history of glycemia-related hospitalizations or emergency ward visits including ketoacidosis, hyperosmolar state, severe hypoglycemia in the previous 6 months.
- Uses anticoagulants or antiplatelet agents that cannot be temporarily discontinued prior to the procedure.
- Has unstable cardiovascular disease, including untreated cardiac arrhythmias, myocardial infarction within last 12 months, New York Heart Association (NYHA) Functional Class III or IV heart failure.
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 |
|---|---|---|
| 10 kHz SCSAlso: Nevro HFX therapy programmed to a frequency of 10 kHz or high frequency, 10 kHz SCSSpinal cord stimulation programmed to a frequency of 10 kHz | Device | 10 kHz SCS plus CMM |
| CMM aloneConventional medical management alone | Other | CMM alone |
Primary outcome
Lower limb pain responder rate
Time frame: 6 months
The lower limb pain responder rate is the proportion of subjects who are pain responders, where a responder is defined as having at least 50% reduction in average lower limb pain score from baseline as measured on a 10-cm Visual Analog Scale (VAS, where a higher score indicates greater pain.
10 secondary outcomes
Neurological improvement responder rate
Time frame: 6 months
Lower limb pain responder rate at 3 months
Time frame: 3 months
Percent change in lower limb pain intensity
Time frame: 6 months
Percent change in PSQ-3
Time frame: 6 months
Average change in EQ-5D-5L index
Time frame: 6 months
Average change in NeuroQol
Time frame: 6 months
Average change in IENF density at the lower calf
Time frame: 6 months
Average change in mTCNS
Time frame: 6 months
Average change in HbA1c
Time frame: 6 months
Average change in body weight
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Derived from this study: PubMed 41309477Pop-Busui R, Petersen EA, Levy BL, Tesfaye S, Armstrong DG, Grunberger G, Boulton AJ, Bharara M, Edgar D, Azalde RP, Caraway D. Evaluating pain and neurological function with high frequency 10 kHz spinal cord stimulation in the treatment of painful diabetic neuropathy: design of a multicentre, randomised controlled trial (PDN-Sensory). BMJ Open. 2025 Nov 27;15(11):e101647. doi: 10.1136/bmjopen-2025-101647.
- Individual participant dataSharing planned: No
Related trials for Painful Diabetic Neuropathy
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 kHz SCS and CMM alone in people with Painful Diabetic Neuropathy, run by Nevro Corp 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 11 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Lower limb pain responder rate (time frame: 6 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 NCT05777317, 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 29 Jun 2026.