Painful Diabetic Neuropathy (PDN)ABBT DPNNCT07250828
Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy
A study testing BurstDR Spinal Cord Stimulation in people with Painful Diabetic Neuropathy (PDN) and Diabetic Neuropathy, run by TriCity Research Center at 1 site in United States.
Trial summary
This prospective, single-arm clinical study evaluates the therapeutic efficacy and feasibility of BurstDR spinal cord stimulation (SCS) using Abbott's Proclaim XR and Eterna systems in patients with painful diabetic neuropathy (PDN). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy (PDN), Diabetic Neuropathy, Neuropathic Pain
- What is being tested?
- BurstDR Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to May 2027
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 years or older.
- Diagnosis of diabetic peripheral neuropathy (DPN) confirmed by nerve conduction study (EMG/NCS) or skin biopsy.
- Persistent neuropathic pain in the lower extremities for ≥6 months.
- Average baseline pain score of ≥6 on the Visual Analog Scale (VAS).
- DN4 score ≥4, indicating neuropathic pain characteristics.
- Inadequate pain relief with conventional medical therapy, including at least two classes of analgesic or neuropathic pain medications (e.g., gabapentinoids, SNRIs, TCAs, opioids).
Show all 9Show fewer
- Candidate for spinal cord stimulation based on clinical evaluation by the treating physician.
- Able and willing to comply with all trial procedures and follow-up visits.
- Able to provide written informed consent in English or in an IRB-approved translated language.
Who cannot join
- Prior spinal cord stimulator implantation or previous SCS trial that was unsuccessful.
- Contraindications to SCS placement, including:
- Active systemic infection or local infection at planned needle entry site
- Bleeding disorders or inability to temporarily discontinue anticoagulation if required
- Known allergy to device materials or components
- Severe uncontrolled medical conditions that increase surgical risk, including:
Show all 15Show fewer
- Unstable cardiovascular disease
- Severe renal or hepatic dysfunction
- Uncontrolled diabetes (e.g., HbA1c > 10%)
- Severe or uncontrolled psychiatric illness that, in the investigator's judgment, may interfere with study compliance.
- Current substance use disorder, including active opioid misuse or illicit drug use, based on clinician assessment.
- Pregnancy or planning to become pregnant during the study period.
- Life expectancy less than 12 months.
- Participation in another interventional clinical trial that may confound results or interfere with study procedures.
- Any condition that, in the investigator's opinion, makes the participant unsuitable for SCS therapy or the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Grand Island Pain Relief Center
Grand Island, Nebraska, 68803
About this study
Official title: Therapeutic Efficacy and Feasibility Study of Abbott's BurstDR Spinal Cord Stimulators Technology for Painful Diabetic Neuropathy (PDN)
This prospective, single-arm clinical study evaluates the therapeutic efficacy and feasibility of BurstDR spinal cord stimulation (SCS) using Abbott's Proclaim XR and Eterna systems in patients with painful diabetic neuropathy (PDN). Adults with confirmed PDN will undergo a one-week temporary SCS trial, and those achieving meaningful improvement (≥50% reduction in average pain on the Visual Analog Scale) will proceed to permanent implantation. Outcomes will be assessed at baseline, end of trial, and at 1-, 3-, and 6-month follow-up visits using validated instruments including VAS, DN4, DQoL, PSQ-3, the Patient Global Impression of Change, and the Clinician Global Impression of Change. All procedures follow standard clinical practice for SCS therapy. The study aims to characterize real-world effectiveness, patient-reported outcomes, feasibility of implementation, and device-related safety in a rural PDN population.
Read the detailed description
This investigator-initiated, post-market clinical study is designed to evaluate the efficacy, feasibility, and safety of BurstDR spinal cord stimulation (SCS) for the management of painful diabetic neuropathy (PDN) using Abbott's Proclaim XR and Eterna implantable pulse generator systems. The SCS systems used in this study are FDA-approved for PDN, and all clinical procedures-including the percutaneous trial phase and permanent implantation-are performed according to standard-of-care practice by experienced clinicians.
Eligible participants are adults aged 19 years or older with confirmed diabetic neuropathy (via EMG or skin biopsy), neuropathic pain severity meeting VAS ≥6 and DN4 ≥4, failure of conventional medical therapy, and suitability for SCS treatment. After informed consent, participants will complete baseline assessments followed by a temporary one-week SCS trial with BurstDR stimulation. Participants who experience meaningful pain reduction during the trial will proceed to permanent implantation. Follow-up assessments occur at 1, 3, and 6 months after implantation, during which validated patient-reported outcomes and clinician-reported measures will be collected. Adverse events, device-related complications, therapy discontinuations, and protocol deviations will be monitored and documented.
The study's primary objective is to determine the proportion of participants achieving ≥50% pain reduction on the Visual Analog Scale at follow-up visits. Secondary objectives evaluate changes in diabetes-related quality of life (DQoL), neuropathic symptoms (DN4), sleep interference (PSQ-3), and patient and clinician impression of change. Tertiary objectives assess feasibility parameters including recruitment rates, retention, protocol adherence, and safety outcomes. Data will be captured and stored using a HIPAA-compliant, 21 CFR Part 11-validated Clinical Trial Management System. The study is conducted at TriCity Research Center with IRB oversight and is funded by Abbott, which has no role in study design, data analysis, or publication decisions.
- Being tested
- BurstDR Spinal Cord Stimulation
- Keywords
- Painful Diabetic Neuropathy, Diabetic Neuropathy, Neuropathic Pain, Spinal Cord Stimulation, BurstDR, Proclaim XR, Eterna SCS, Neuromodulation
- Medical subject headings
- Diabetic Neuropathies, Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BurstDR Spinal Cord StimulationDevice
Also called Proclaim, Eterna, Burst DR, Spinal Cord Stimulator
Participants receive BurstDR spinal cord stimulation delivered through Abbott Proclaim XR or Eterna spinal cord stimulator systems in a standard of care routine. The intervention includes a one-week temporary SCS trial using percutaneous leads, followed by permanent implantation of the Proclaim XR or Eterna implantable pulse generator for participants who experience meaningful pain relief during the trial. Device programming and follow-up assessments follow standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Test Group [Burst DR SCS] | Experimental | Participants receive BurstDR spinal cord stimulation delivered through Abbott Proclaim XR or Eterna systems, beginning with a temporary trial followed by permanent implantation for responders. Receives: Device: BurstDR Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Change Baseline to 6 Month
Pain will be assessed using the Visual Analog Scale (VAS). The primary endpoint is the proportion of participants who achieve at least a 50% reduction in average VAS pain score from baseline to each follow-up visit after permanent implantation.
Measured: 1 month, 3 months, and 6 months
Secondary outcomes (3)
Diabetes QoL Change Baseline to 6 Months
Quality of life will be assessed using the Diabetes Quality of Life (DQoL) questionnaire. The outcome is the change in total DQoL score from baseline to each follow-up visit. Clinically meaningful improvement is defined as a ≥0.05-point increase in the DQoL index.
Measured: 1 month, 3 months, and 6 months after permanent implantation
Change in DN4 neuropathic pain score
Neuropathic symptoms will be measured using the DN4 questionnaire. The outcome is the change in DN4 score from baseline to follow-up. Clinically meaningful improvement is defined as a ≥2-point reduction in DN4 score.
Measured: 1 month, 3 months, and 6 months after permanent implantation
Change in pain-related sleep interference (PSQ-3)
Sleep interference will be assessed using the Pain and Sleep Questionnaire-3 item (PSQ-3). The outcome is the percentage reduction in PSQ-3 score from baseline to follow-up. Clinically meaningful improvement is defined as a ≥30% reduction.
Measured: 1 month, 3 months, and 6 months after permanent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start15 Dec 2025
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic Neuropathy (PDN)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm study in which all participants receive BurstDR spinal cord stimulation using Abbott Proclaim XR or Eterna systems.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriCity Research Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250828
- Sponsor's protocol ID
- IIS-25-ABT-002
- Other IDs
- ABT-002
- Acronym
- ABBT DPN
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy and Feasibility Study of Abbott's BurstDR Spinal Cord Stimulators Technology for Painful Diabetic Neuropathy (PDN)
- ClinicalTrials.gov ID
- NCT07250828
- Acronym / sponsor ID
- ABBT DPN / IIS-25-ABT-002
- Keywords
- Painful Diabetic Neuropathy, Diabetic Neuropathy, Neuropathic Pain, Spinal Cord Stimulation, BurstDR, Proclaim XR, Eterna SCS, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TriCity Research CenterIndustry (pharma, biotech, devices)
- Collaborators
- Abbott
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Nov 2025 (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 prospective, single-arm clinical study evaluates the therapeutic efficacy and feasibility of BurstDR spinal cord stimulation (SCS) using Abbott's Proclaim XR and Eterna systems in patients with painful diabetic neuropathy (PDN). Adults with confirmed PDN will undergo a one-week temporary SCS trial, and those achieving meaningful improvement (≥50% reduction in average pain on the Visual Analog Scale) will proceed to permanent implantation. Outcomes will be assessed at baseline, end of trial, and at 1-, 3-, and 6-month follow-up visits using validated instruments including VAS, DN4, DQoL, PSQ-3, the Patient Global Impression of Change, and the Clinician Global Impression of Change. All procedures follow standard clinical practice for SCS therapy. The study aims to characterize real-world effectiveness, patient-reported outcomes, feasibility of implementation, and device-related safety in a rural PDN population.
Detailed description
This investigator-initiated, post-market clinical study is designed to evaluate the efficacy, feasibility, and safety of BurstDR spinal cord stimulation (SCS) for the management of painful diabetic neuropathy (PDN) using Abbott's Proclaim XR and Eterna implantable pulse generator systems. The SCS systems used in this study are FDA-approved for PDN, and all clinical procedures-including the percutaneous trial phase and permanent implantation-are performed according to standard-of-care practice by experienced clinicians.
Eligible participants are adults aged 19 years or older with confirmed diabetic neuropathy (via EMG or skin biopsy), neuropathic pain severity meeting VAS ≥6 and DN4 ≥4, failure of conventional medical therapy, and suitability for SCS treatment. After informed consent, participants will complete baseline assessments followed by a temporary one-week SCS trial with BurstDR stimulation. Participants who experience meaningful pain reduction during the trial will proceed to permanent implantation. Follow-up assessments occur at 1, 3, and 6 months after implantation, during which validated patient-reported outcomes and clinician-reported measures will be collected. Adverse events, device-related complications, therapy discontinuations, and protocol deviations will be monitored and documented.
The study's primary objective is to determine the proportion of participants achieving ≥50% pain reduction on the Visual Analog Scale at follow-up visits. Secondary objectives evaluate changes in diabetes-related quality of life (DQoL), neuropathic symptoms (DN4), sleep interference (PSQ-3), and patient and clinician impression of change. Tertiary objectives assess feasibility parameters including recruitment rates, retention, protocol adherence, and safety outcomes. Data will be captured and stored using a HIPAA-compliant, 21 CFR Part 11-validated Clinical Trial Management System. The study is conducted at TriCity Research Center with IRB oversight and is funded by Abbott, which has no role in study design, data analysis, or publication decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm study in which all participants receive BurstDR spinal cord stimulation using Abbott Proclaim XR or Eterna systems.
| Arm | Type | Receives |
|---|---|---|
| Test Group [Burst DR SCS] | Experimental | Device: BurstDR Spinal Cord StimulationParticipants receive BurstDR spinal cord stimulation delivered through Abbott Proclaim XR or Eterna systems, beginning with a temporary trial followed by permanent implantation for responders. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 19 years or older.
- Diagnosis of diabetic peripheral neuropathy (DPN) confirmed by nerve conduction study (EMG/NCS) or skin biopsy.
- Persistent neuropathic pain in the lower extremities for ≥6 months.
- Average baseline pain score of ≥6 on the Visual Analog Scale (VAS).
- DN4 score ≥4, indicating neuropathic pain characteristics.
Key exclusion criteria (15 listed)
- Prior spinal cord stimulator implantation or previous SCS trial that was unsuccessful.
- Contraindications to SCS placement, including:
- Active systemic infection or local infection at planned needle entry site
- Bleeding disorders or inability to temporarily discontinue anticoagulation if required
- Known allergy to device materials or components
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 |
|---|---|---|
| BurstDR Spinal Cord StimulationAlso: Proclaim, Eterna, Burst DR, Spinal Cord StimulatorParticipants receive BurstDR spinal cord stimulation delivered through Abbott Proclaim XR or Eterna spinal cord stimulator systems in a standard of care routine. The intervention includes a one-week temporary SCS trial using percutaneous leads, followed by permanent implantation of the Proclaim XR or Eterna implantable pulse generator for participants who experience meaningful pain relief during the trial. Device programming and follow-up assessments follow standard clinical practice. | Device | Test Group [Burst DR SCS] |
Primary outcome
VAS Change Baseline to 6 Month
Time frame: 1 month, 3 months, and 6 months
Pain will be assessed using the Visual Analog Scale (VAS). The primary endpoint is the proportion of participants who achieve at least a 50% reduction in average VAS pain score from baseline to each follow-up visit after permanent implantation.
3 secondary outcomes
Diabetes QoL Change Baseline to 6 Months
Time frame: 1 month, 3 months, and 6 months after permanent implantation
Change in DN4 neuropathic pain score
Time frame: 1 month, 3 months, and 6 months after permanent implantation
Change in pain-related sleep interference (PSQ-3)
Time frame: 1 month, 3 months, and 6 months after permanent implantation
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 8 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Painful Diabetic Neuropathy (PDN)
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies
Not yet recruitingPhase 4
Efficacy of Topical Lidocaine Gel vs. Oral Duloxetine for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Neuropathies
Active, not recruiting
Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy
Active, not recruiting
PDN Post Market, Multicenter, Prospective, Global Clinical Study
Diabetic Neuropathy, Painful
Recruiting
The Treatment of Painful Diabetic Neuropathy With Diet
Painful Diabetic Neuropathy (PDN), Peripheral Neuropathy With Type 2 Diabetes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BurstDR Spinal Cord Stimulation in people with Painful Diabetic Neuropathy (PDN) and Diabetic Neuropathy, run by TriCity Research Center 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 9 inclusion and 15 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: enrolling by invitation, as of the sponsor's last update on 8 May 2026. 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?
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?
VAS Change Baseline to 6 Month (time frame: 1 month, 3 months, and 6 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 8 May 2026.