PDN Post Market, Multicenter, Prospective, Global Clinical Study (PDN-PM)

  • STATUS
    Recruiting
  • End date
    Mar 8, 2026
  • participants needed
    497
  • sponsor
    Nevro Corp
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Updated on 8 July 2022
See if I qualify
diabetes
treatment regimen
painful diabetic neuropathy

Summary

The purpose of this post-market study is to evaluate the real-world experience of Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic, intractable leg pain due to painful diabetic neuropathy (PDN). This is a multicenter, prospective, observational global study, that will partner diabetes management teams with pain physicians to provide an interdisciplinary treatment regimen for PDN patients. Outcomes will be assessed via standardized assessments.

Details
Condition Diabetic Neuropathy, Painful
Treatment Spinal Cord Stimulator (SCS)
Clinical Study IdentifierNCT05301816
SponsorNevro Corp
Last Modified on8 July 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

To participate in the study, patients must meet all the following inclusion
criteria
Have been clinically diagnosed with diabetes, according to the local country diabetes association guidelines, as well as painful diabetic neuropathy (PDN) of the lower limbs refractory to conventional medical management
Average pain intensity (over the last 7 days) of ≥5 out of 10 cm on the Visual Analog Scale (VAS) in the lower limbs at enrollment/baseline
The clinical decision has been made to provide treatment using the Nevro Spinal Cord Stimulation that includes 10 kHz therapy prior to enrollment in the study
Be willing and capable of giving written informed consent
Be willing and able to comply with study-related requirements and procedures and attend all scheduled visits

Exclusion Criteria

To participate in the study, patients must not meet any of the following exclusion
criteria
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, or have
large (≥3 cm) and/or gangrenous ulcers of the lower limbs
Have a medical condition or diagnosis that is inconsistent with Nevro's SCS System
guidelines in the Physician's Manual for the relevant country, or as per standard
clinical practice
Have a medical condition or pain in other areas, not intended to be treated in this
study, that could interfere with study procedures, accurate pain reporting, and/or
confound the evaluation of study endpoints, as determined by the Investigator (such as
primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis, peripheral
vascular disease, or small vessel disease)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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