This is a two-phase study.
Phase 1 is a double blinded, two-arm, randomized, multi-center clinical trial to assess 1-month efficacy as compared to a sham group. Up to approximately 80 subjects diagnosed with painful diabetic neuropathy will be randomized 3:1 into one of two treatment groups:
Axon Therapy plus CMM (AT+CMM)
Sham plus CMM (Sham+CMM)
Subjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments.
All subjects will return to the clinic for treatments as follows:
â—Ź Day 1 – 30: 6 treatments
Week 1: 3 treatments
Week 2-4: Weekly treatments
All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study.
Phase 2 of the study is an unblinded, one-arm, multi-center trial to assess extended efficacy of the treatment. At Day 30, subjects will be unblinded and allowed to remain in the study for an additional 60 (AT+CMM) to 90 (ATx+CMM) days. Those in the Sham arm can choose to crossover to active treatment ( ATx+CMM).
Subjects in the AT+CMM arm will return to the clinic as follows:
Month 2: Bi-weekly treatment
Month 3: Treatments every 2-4 weeks
Additional treatments to treat flare ups; defined as an episode of pain with a VAS 6.
Subjects in the ATx+CMM arm will return to the clinic as follows:
Month 2: 6 treatments
Week 1: 3 treatments
Week 2-4: Weekly treatments
Month 3: Bi-weekly treatment
Month 4: Treatments every 2-4 weeks
Additional treatments to treat flare ups; defined as an episode of pain with a VAS 6.
Subjects who do not choose to remain in the study will be monitored for 30 days for AEs and then they will exit the study. The subject’s reason for exiting the study will be recorded.
In addition to in-clinic assessments and treatments, all subjects will complete an electronic twice daily diary through Day 30 of the study (Day 60 for ATx+CMM subjects). Subjects will receive weekly phone follow-up for diary reminders and to assess for the occurrence of adverse events. Weekly phone follow-up will occur only during weeks when the subject is not seen in the clinic.
Source: View full study details on ClinicalTrials.gov
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