Dual Field PEMF Therapy in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy
Condition: Diabetic Neuropathy Peripheral
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      Part A of this trial is a multi-center, prospective, double-blinded, sham-controlled,
      randomized clinical trial. Part A will evaluate PEMF treatment compared to sham treatment in
      patients with painful diabetic distal symmetric peripheral neuropathy (DSPN) when treatment
      is administered 30 minutes twice daily through a 120-day period (4 months). Part B is a
      8-month open-label active treatment extension period designed to collect longer-term data on
      pain, medication use, quality of life and safety (Part B).Part B of this trial is a an
      extension period upon completion of Part A.
    

Detailed description: 
      Eligible subjects will be entered into a 14-day ePRO diary run-in period to collect average
      baseline pain scores related to their diabetic neuropathy in the lower extremities, diary
      compliance, and analgesic consumption (maintenance and prn prescribed peripheral neuropathic
      pain medication pill counts). Subjects will collect electronic patient-reported outcome
      (ePRO) data each morning around the same time during the run-in period.

      Subjects will return to the clinic at Baseline (Day 0) for review of eligibility, diary
      compliance, average baseline diabetic neuropathic pain score of ≥4 and <9, and review of
      stable analgesic pain consumption profile during the 14-day run-in period. Qualified subjects
      based on diary compliance and average pain score will be randomized 1:1 (active: sham) and
      will be instructed to self-treat twice daily for 120 days. Subjects will record electronic
      patient-reported outcome (ePRO) data following each morning treatment for 120 days. Subjects
      consenting to distal thigh and distal leg skin biopsies during the Screening visit will have
      biopsies collected and sent to the central laboratory for assessment. All subjects will have
      baseline assessments conducted.

      Subjects will receive a telephone call at Day 7 to ensure compliance to treatment and diary
      completion, provide follow-up information on the biopsy sites (if applicable), complete a
      blinding assessment as well as be assessed for safety and concomitant medication changes.

      At Month 1 subjects will return to the clinic for evaluation of safety, concomitant
      medication changes, review device usage and ePRO diary completion, and Patient Global
      Impression (PGI). Treatment satisfaction will also be assessed.

      At Month 2 subjects will return to the clinic for evaluation of safety, concomitant
      medication changes, treatment satisfaction, review of device usage (reports will be supplied
      to the site) and ePRO diary completion, quality of life outcomes (WPAIQ and NeuroQoL),
      Patient Global Impression (PGI), and interim visit measurements of SPP.

      At Month 3, subjects will return to the clinic for evaluation of safety, concomitant
      medication changes, review device usage (reports will be supplied to the site) and ePRO diary
      completion, and Patient Global Impression (PGI). Treatment satisfaction will also be
      assessed.

      At Month 4 (end of Part A / start of Part B), subjects will return to the clinic for
      evaluation of safety, treatment satisfaction, review of device usage (reports will be
      supplied to the site), HbA1c, concomitant medication changes, weight, quality of life
      outcomes (WPAIQ and NeuroQoL), PGI, final measurements of SPP, NCS, QST and be assessed to
      determine their Toronto Clinical Neuropathy Score. Those subjects who consented and had
      biopsies collected at the Enrollment visit, will have their end of study biopsies during this
      visit and samples sent directly to the central laboratory for assessment. Subjects will
      return the study device and complete a blinding assessment.

      Subjects that complete Part A will continue into the open-label extension period (Part B).
      All subjects will be reconsented if not completed at a prior visit and given an open-label
      active device. Subjects will record ePRO data for one week prior to the Month 6, 8, 10, and
      12 visits following each morning treatment. Subjects will be reminded of the150-day (Month 5)
      phone call.

      At Month 5, subjects will receive a telephone call to ensure compliance to treatment, and to
      be assessed for safety and concomitant medication changes.

      At Month 6, subjects will receive a telephone call to ensure treatment compliance and
      collection of diary data, and to assess safety and concomitant medication changes.

      At Month 7, subjects will receive a telephone call to ensure treatment compliance, and to
      assess safety and concomitant medication changes.

      At Month 8, subjects will return to the clinic for evaluation of safety, measure QST,
      treatment satisfaction, review of device usage and collection of diary data, concomitant
      medication changes, quality of life outcomes (NeuroQoL), and PGI.

      At Month 9, subjects will receive a telephone call to ensure treatment compliance, and to
      assess safety and concomitant medication changes.

      At Month 10, subjects will receive a telephone call to ensure treatment compliance and
      collection of diary data, and to assess safety and concomitant medication changes.

      At Month 11, subjects will receive a telephone call to ensure treatment compliance, and to
      assess safety and concomitant medication changes.

      At Month 12 (end of open-label treatment extension), subjects will return to the clinic for
      evaluation of safety, weight, QST, NCS, TCNSS, PGI, treatment satisfaction, review of device
      usage and collection of diary data, concomitant medication changes, quality of life outcomes
      (NeuroQoL), and will return the study device. Subjects who consented and had biopsies
      collected at the 4 Month visit, will have their end of study biopsies performed during this
      visit.
    

Intervention name(s): Active Provant Therapy System; Inactive (sham) Provant Therapy System
Intervention type(s): Device; Device
Intervention description(s): Treatment with active Provant Therapy System; Treatment with inactive Provant Therapy System
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two parallel groups, active device group versus sham device group. Subjects will be randomized 1:1 at baseline and treat with active PEMF or sham for 4 months.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment