In a prospective, multicenter, randomized controlled trial (SENZA-PDN), 216 subjects with PDN will be assigned 1:1 to receive 10 kHz HF-SCS combined with CMM or CMM alone after appropriate institutional review board (IRB) approvals. Key inclusion criteria include: 1) diagnosis of PDN for at least 12 months, 2) average pain intensity of ≥5 cm (on a 0-10 cm visual analog scale [VAS]) in the lower limbs, and 3) an appropriate candidate for SCS. Key exclusion criteria include: 1) large and/or gangrenous ulcers, and 2) average pain intensity of ≥3 cm on VAS in the upper limbs. Along with pain VAS, neurological assessments, health-related quality of life, sleep quality, and patient satisfaction will be captured. Subject follow-up will last for 24 months.

The primary endpoint comparing responder rates (≥50% symptom relief) and safety rates between the treatment groups will be assessed at 3 months.

Enrollment in the SENZA-PDN study commenced in 2017 and is expected to be complete in 2019.

The SENZA-PDN study will be the largest RCT conducted using SCS in subjects with PDN. This prospective, multicenter study will determine whether 10 kHz HF-SCS  improves clinical outcomes, health-related quality of life, and is cost-effective treatment for PDN.