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A Novel Non-Pharmacological Treatment of Diabetic Neuropathy

NCT05414968 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-08-04

No results posted yet for this study

Summary

The objective of the proposed work is to develop non-pharmacological interventions for diabetic peripheral neuropathy (DPN), to improve quality of life of individuals with diabetes, and reduce the prevalence of opiate prescription, sensation loss, falls, and deaths caused by DPN. To this end, the proposed study will investigate and determine the feasibility of the non-pharmacological intervention device. The feasibility study involves 16 participants, split evenly between pre-neuropathic diabetic and neuropathic diabetic participants. During the study, each group will receive the same 45-minute intervention on 10 days spread over no more than 14 days total. Feasibility will be determined by change in pain assessed before and after intervention.

Conditions

  • Diabetic Peripheral Neuropathy

Interventions

DEVICE

Non-pharmacological Heat, Pressure, and Vibration

The innovation central to this approach is in the multifactorial combination of pressure, heat, and vibration stimuli to improve foot sensation. The heat stimuli will be provided with commercially available heating elements. The pressure stimuli will be provided via pneumatic garment. Lastly, the vibrotactile stimuli will be provided with commercially available vibrotactile motors. The non-pharmacological DPN device will be able to safely and consistently control temperature to 100-105°F within 1°F, control pressure to 50 mmHg within 5 mmHg at 0.25 Hz, and provide 5 distinguishable vibrational stimuli to 5 zones on the leg and foot.

Sponsors & Collaborators

  • Auburn University

    lead OTHER

Principal Investigators

  • Chad G Rose, PhD · Auburn University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2024-12-31
Completion
2025-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05414968 on ClinicalTrials.gov