At a glance
ClinicalIndex Comparison RecordN/AUnknown· 430 enrolled
Drug / intervention
Senza HF10 Therapy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Post-Market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation (HF10™ Therapy) Combined With Conventional Medical Management to Conventional Medical Management Alone in the Treatment of Chronic, Intractable, Neuropathic Limb Pain
In Brief
A clinical study evaluating Senza HF10 Therapy and CMM for Painful Diabetic Neuropathy. Targeting 430 participants across 4 sites.
Detailed Summary
This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy (Painful Diabetic Neuropathy or PDN). This study is a multi-center, prospective, randomized comparison of the two treatments.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPainful Diabetic Neuropathy
CountriesUnited States
Collaborators--
Timeline
N/AUnknownOverdue
201820192020202120222023202420252026
Enrollment StartJul 2017
First PostedJul 2017
Primary CompletionMay 2020
Study CompletionDec 2022
TodayJul 2026
First PostedJul 24, 2017
Enrollment StartJul 20, 2017
Primary CompletionMay 1, 2020
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.9 years ago
Interventions
Senza HF10 Therapydevice
Senza 10kHz Spinal Cord Stimulation
CMMother
Conventional Medical Management