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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Abbott Medical Devices
Study ID
NCT05537662
Status
Recruiting
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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of care neuromodulation therapy (SCS or DRG) — DEVICE
    Standard SCS or DRG therapy

Study Details

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.

Key Dates

Start date
Jun 6, 2023
Status verified
Jul 2024
Primary completion
Jan 31, 2025
Completion
Apr 30, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Subjects using Neuromodulation Therapy (SCS or DRG)
    Patients will trial standard of care neuromodulation therapy (SCS or DRG), and if successful will proceed to a permanent implant.

Primary Outcome Measure

The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 3 months [ Time Frame: At 3 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Daniel Torrez, BS
[email protected]
312-942-2741
Tolga Suvar, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Rush University Medical Center· Chicago, IL

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