NCT05537662

External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes (XANADO)

External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, longitudinal, single-center, non-randomized, open-label, post-market clinical feasibility study to assess the efficacy of neuromodulation therapies (SCS and DRG) for chronic pain patients with diabetes and investigate whether physical and physiological data collected from diabetic and pre-diabetic chronic pain patients is predictive of subjective patient-reported outcomes (PROs) and of adjustments in patient care. These assessments will be made prior to, during, and after the trial of the SCS or DRG system. The study will be carried out in the United States at a single site.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Standard of care neuromodulation therapy (SCS or DRG)	Standard SCS or DRG therapy

Timeline

• Start date: 2023-06-06
• Primary completion: 2025-01-01
• Completion: 2025-04-01
• First posted: 2022-09-13
• Last updated: 2024-07-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study