Painful Diabetic NeuropathyNCT05985291
BurstDR Stimulation for Painful Diabetic Neuropathy
An observational study of Painful Diabetic Neuropathy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study aims to demonstrate treatment outcomes of Painful Diabetic Neuropathy (PDN) patients treated with BurstDRTM Spinal Cord Dorsal Column Stimulator (SCS) along with conservative medical management per standard of care. 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?
- SCS in combination with CMM
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2023to 6 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: This study will include patients older than 21 suffering from Painful Diabetic Neuropathy.
Who may be able to join
- Diagnosis of lower extremity Painful Diabetic Neuropathy (PDN) with symptoms for at least a year prior to signing the consent form
- PDN refractory to FDA approved medications: duloxetine, pregabalin, tapentadol, and capscaicin
- Lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS)
- HbA1c ≤10%
- BMI <45 kg/m2
- Be 22 years of age or older at the time of enrollment
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- Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English
- Be willing and capable of giving informed consent
- Be willing and able to comply with study-related requirements, procedures, and scheduled visits
- Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator
- Be on a stable analgesic regimen, as determined by the Investigator, for at least 30 days prior to assessing pain intensity, and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device
- Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator
Who cannot join
- Current daily opioid dosage greater than 120 mg morphine equivalents
- Have an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upper extremities due to diabetic neuropathy at enrollment
- Have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial or peroneal neuropathies), have had a lower limb amputation other than toes due to diabetes, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.
- Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury, as determined by the Investigator
- Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, low platelet count, severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure, as determined clinically by the Investigator
- Be benefitting from an interventional procedure and/or surgery to treat lower limb pain (Subjects should be enrolled at least 30 days from last benefit).
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- Have an existing intrathecal pain pump and/or another active implantable device such as a pacemaker
- Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with ProclaimTM system guidelines in the Physician's Manual
- Have either a metastatic malignant neoplasm or untreated local malignant neoplasm
- Have a life expectancy of less than one year
- Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs
- Be concomitantly participating in another clinical study
- Be involved in an injury claim under current litigation
- Be a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to chronic pain
- Have a pending or approved worker's compensation claim
- Have 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 a psychologist in the last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BurstDRTM Spinal Cord Dorsal Column Stimulation for Painful Diabetic Neuropathy
This study aims to demonstrate treatment outcomes of Painful Diabetic Neuropathy (PDN) patients treated with BurstDRTM Spinal Cord Dorsal Column Stimulator (SCS) along with conservative medical management per standard of care.
Read the detailed description
In this study, we aim to systematically collect real world, observational and prospective data on the safety and effectiveness of an SCS system for the management of PDN. This study will provide, to the best of our knowledge, the first clinical, real world, prospective data in treatment of PDN with an SCS system.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- SCS in combination with CMM
- Keywords
- neurostimulation, spinal cord stimulation, burst 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.
SCS in combination with CMMCombination product
Subjects receiving BurstDR spinal cord dorsal column stimulation in combination with conservative medical management for the treatment of painful diabetic neuropathy as part of regular medical care.
| Study group | Role | What they receive |
|---|---|---|
| PDN treated with SCS and CMM | Painful diabetic neuropathy patients treated with burst stimulation along with conservative medical management as part of regular medical care. Receives: Combination Product: SCS in combination with CMM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change from baseline to 3 months in treatment responder rates
Responder is defined as a subject who has at least 50% reduction in lower limb pain from baseline as measured by a 10 cm Visual Analog Scale (VAS).
Measured: 3 months
Secondary outcomes (1)
Average change from baseline to 6 months in treatment responder rates assessed by Visual Analog Scale (0-10 cm)
0 no pain at all, 10 worse pain imaginable
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 posted14 Aug 2023
- Study start3 Jul 2023
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Why it stopped: Principal Investigator left Advocate Health
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mansoor Aman, MD, Principal investigator, Aurora Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985291
- Sponsor's protocol ID
- IRB00104842
- Other IDs
- 23-817
- Status last verified
- Nov 2025
- First submitted
- 6 Jul 2023
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BurstDRTM Spinal Cord Dorsal Column Stimulation for Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05985291
- Acronym / sponsor ID
- IRB00104842
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- neurostimulation, spinal cord stimulation, burst stimulation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator left Advocate Health
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 14 Aug 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.
This study aims to demonstrate treatment outcomes of Painful Diabetic Neuropathy (PDN) patients treated with BurstDRTM Spinal Cord Dorsal Column Stimulator (SCS) along with conservative medical management per standard of care.
Detailed description
In this study, we aim to systematically collect real world, observational and prospective data on the safety and effectiveness of an SCS system for the management of PDN. This study will provide, to the best of our knowledge, the first clinical, real world, prospective data in treatment of PDN with an SCS system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDN treated with SCS and CMM | – | Combination Product: SCS in combination with CMMPainful diabetic neuropathy patients treated with burst stimulation along with conservative medical management as part of regular medical care. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include patients older than 21 suffering from Painful Diabetic Neuropathy.
Key inclusion criteria (13 listed)
- Diagnosis of lower extremity Painful Diabetic Neuropathy (PDN) with symptoms for at least a year prior to signing the consent form
- PDN refractory to FDA approved medications: duloxetine, pregabalin, tapentadol, and capscaicin
- Lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS)
- HbA1c ≤10%
- BMI <45 kg/m2
Key exclusion criteria (16 listed)
- Current daily opioid dosage greater than 120 mg morphine equivalents
- Have an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upper extremities due to diabetic neuropathy at enrollment
- Have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial or peroneal neuropathies), have had a lower limb amputation other than toes due to diabetes, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.
- Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury, as determined by the Investigator
- Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, low platelet count, severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure, as determined clinically by the Investigator
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 |
|---|---|---|
| SCS in combination with CMMSubjects receiving BurstDR spinal cord dorsal column stimulation in combination with conservative medical management for the treatment of painful diabetic neuropathy as part of regular medical care. | Combination product | PDN treated with SCS and CMM |
Primary outcome
Average change from baseline to 3 months in treatment responder rates
Time frame: 3 months
Responder is defined as a subject who has at least 50% reduction in lower limb pain from baseline as measured by a 10 cm Visual Analog Scale (VAS).
1 secondary outcome
Average change from baseline to 6 months in treatment responder rates assessed by Visual Analog Scale (0-10 cm)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Principal Investigator left Advocate Health). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Painful Diabetic Neuropathy
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Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
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Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
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SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.
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Neurofeedback for the Management of Neuropathic Pain in People With Diabetes
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Not yet recruitingPhase 4
Efficacy of Topical Lidocaine Gel vs. Oral Duloxetine for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Neuropathies
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.
Mansoor Aman, MD principal investigator
Aurora Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Painful Diabetic Neuropathy, run by Wake Forest University Health Sciences 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 13 inclusion and 16 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: stopped early, as of the sponsor's last update on 6 Nov 2025. 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?
The study was stopped early (reason given: Principal Investigator left Advocate Health). Results are not available in the source record.
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?
Average change from baseline to 3 months in treatment responder rates (time frame: 3 months). 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 6 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.