Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
6 participants
OBSERVATIONAL
2023-07-03
2025-10-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
SCS in combination with CMM
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SCS in combination with CMM
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wake Forest University Health Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mansoor Aman, MD
Role: PRINCIPAL_INVESTIGATOR
Aurora Healthcare
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aurora Health Oshkosh
Oshkosh, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23-817
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00104842
Identifier Type: -
Identifier Source: org_study_id