A Novel Non-Pharmacological Treatment of Diabetic Neuropathy

Sponsor

Auburn University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05414968

Collaborator

(none)

Enrollment

Arm

4.9

Anticipated Duration (Months)

Study Details

Study Description

Brief 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 5 days spread over no more than 10 days total. Feasibility will be determined by change in pain assessed before and after intervention.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Peripheral Neuropathy	Device: Non-pharmacological Heat, Pressure, and Vibration	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

16 participants will be recruited (8 pre-neuropathic, 8 neuropathic) to evaluate device feasibility through 5 sessions spread over 10 days.16 participants will be recruited (8 pre-neuropathic, 8 neuropathic) to evaluate device feasibility through 5 sessions spread over 10 days.

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

A Novel Non-Pharmacological Treatment of Diabetic Neuropathy

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pilot Feasibility Arm Each participant will receive the same 45-minute intervention on 5 days spread over no more than 10 days total. At the end of each session, pain will be assessed on scales such as the Defense and Veterans Pain Rating Scale (DVPRS) to establish the safety and feasibility of the proposed intervention.	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 a small, low power stepper motor connected to a nylon strap. 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.

Arm

Intervention/Treatment

Experimental: Pilot Feasibility Arm

Each participant will receive the same 45-minute intervention on 5 days spread over no more than 10 days total. At the end of each session, pain will be assessed on scales such as the Defense and Veterans Pain Rating Scale (DVPRS) to establish the safety and feasibility of the proposed intervention.

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 a small, low power stepper motor connected to a nylon strap. 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.

Outcome Measures

Primary Outcome Measures

Change from Baseline Pain Assessment [immediately after each session (up to 30 minutes)]
Defense and Veterans Pain Rating Scale (DVPRS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

diagnosis of type 2 diabetes for at least 5 years
lab histories that verify participant's control or lack of blood sugars dating back for a period of 1-5 years

Exclusion Criteria:

other diseases or impairments that could affect results (vascular disease verified from medical history
ankle-brachial index (ABI) of 0.9 or less

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Auburn University

Investigators

Principal Investigator: Chad G Rose, PhD, Auburn University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chad Rose, Assistant Professor, Auburn University

ClinicalTrials.gov Identifier:

NCT05414968

Other Study ID Numbers:

22-114

First Posted:

Jun 10, 2022

Last Update Posted:

Jun 10, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chad Rose, Assistant Professor, Auburn University

nonpharmacological intervention

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Diabetic Neuropathies

Study Results

No Results Posted as of Jun 10, 2022