BurstDR Stimulation for Painful Diabetic Neuropathy

NCT05985291 | Terminated

• 2 other identifiers: IRB0010484223-817
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Painful Diabetic Neuropathy

Keywords

neurostimulation; spinal cord stimulation; burst stimulation

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months

Secondary Outcomes (1)

• Average change from baseline to 6 months in treatment responder rates assessed by Visual Analog Scale (0-10 cm)

  6 months

Other Outcomes (12)

• Percentage of patients with change from baseline in sensory neurological assessment at 3 months

  3 months

• Average change from baseline to 3 months in severity of neuropathic pain as measured by Neuropathic Pain 4 Questions (DN4) (0-10)

  3 months

• Average change from baseline in CGM metrics from AGP report at 3 months

  3 months

Study Arms (1)

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.

Combination Product: SCS in combination with CMM

Interventions

SCS in combination with CMM COMBINATION_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.

PDN treated with SCS and CMM

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will include patients older than 21 suffering from Painful Diabetic Neuropathy.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora Health Oshkosh

Oshkosh, Wisconsin, 54914, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Carubicin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Mansoor Aman, MD

  Aurora Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 14, 2023
• Study Start: July 3, 2023
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)