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Trial · NCT07911410

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Toronto Clinical Scoring System (TCSS) total score from baseline to 3 months after surgery3 months after surgery
Change in total score of the Toronto Clinical Scoring System (TCSS) measured at 3 months after surgery relative to baseline. Full scale name: Toronto Clinical Scoring System Scale range: Minimum score = 0, Maximum score = 19 Interpretation: Higher total score indicates more severe diabetic peripheral neuropathy. Lower total score indicates less severe neuropathy.
SecondaryPlantar TemperaturePostoperative day 1Bilateral plantar temperature measured before PNS activation on postoperative day 1.
SecondaryPercentage Change in Neuropathic Symptom Score at Postoperative Day 1Postoperative day 1Percentage change in neuropathic symptom score assessed one day after surgery relative to baseline.
SecondaryStable Minimum Bilateral Plantar Temperature After One-week PNS StimulationOne week after PNS stimulation (before electrode removal)The minimum stable bilateral plantar temperature recorded before electrode removal after one week of peripheral nerve stimulation.
SecondaryPercentage Change in Diabetic Neuropathic Symptom Score Before Electrode RemovalOne week after PNS stimulationPercentage change in diabetic neuropathic symptom score assessed before electrode removal after one week of continuous PNS stimulation, relative to baseline.
SecondaryDiabetic Foot Risk Status at 3 Months Postoperatively3 months after operationComprehensive assessment of diabetic foot risk indicators at 3 months after surgery.
SecondaryChange in Lower Limb Nerve Conduction Velocity Measured by Electromyography at 3 Months Postoperatively3 months after operationChange in lower limb nerve conduction velocity detected by electromyography at 3 months after surgery.
SecondaryStatus of Neurotrophic Agent Use at 3 Months Postoperatively3 months after operationChanges in the use and dosage of neurotrophic drugs at 3 months after surgery.
SecondaryStatus of Hypoglycemic Agent Use at 3 Months Postoperatively3 months after operationChanges in the use and dosage of hypoglycemic agents at 3 months after surgery.
SecondaryStatus of Analgesic Medication Use at 3 Months Postoperatively3 months after operationChanges in the use and dosage of analgesic medications at 3 months after surgery.
SecondaryParticipant-reported Satisfaction Level for Combined Surgical Treatment at 3 Months Postoperatively3 months after operationParticipant self-reported satisfaction level regarding the combined surgical treatment at 3 months after surgery.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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