A Novel Non-Pharmacological Treatment of Diabetic Neuropathy

NCT05414968 | Unknown

• 1 other identifier: 22-114
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 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

Keywords

nonpharmacological intervention

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Pain Assessment

  Defense and Veterans Pain Rating Scale (DVPRS)

  immediately after each session (up to 30 minutes)

Study Arms (1)

Pilot Feasibility Arm

EXPERIMENTAL

Each participant will receive the same 45-minute intervention on 10 days spread over no more than 14 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

Interventions

Non-pharmacological Heat, Pressure, and Vibration DEVICE

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.

Pilot Feasibility Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

RECRUITING

Related Publications (3)

• Lotz J, Meier C, Leppert A, Galanski M. Cardiovascular flow measurement with phase-contrast MR imaging: basic facts and implementation. Radiographics. 2002 May-Jun;22(3):651-71. doi: 10.1148/radiographics.22.3.g02ma11651.

  PMID: 12006694 BACKGROUND

• Feldman EL, Nave KA, Jensen TS, Bennett DLH. New Horizons in Diabetic Neuropathy: Mechanisms, Bioenergetics, and Pain. Neuron. 2017 Mar 22;93(6):1296-1313. doi: 10.1016/j.neuron.2017.02.005.

  PMID: 28334605 BACKGROUND

• Buckenmaier CC 3rd, Galloway KT, Polomano RC, McDuffie M, Kwon N, Gallagher RM. Preliminary validation of the Defense and Veterans Pain Rating Scale (DVPRS) in a military population. Pain Med. 2013 Jan;14(1):110-23. doi: 10.1111/j.1526-4637.2012.01516.x. Epub 2012 Nov 8.

  PMID: 23137169 BACKGROUND

Study Officials

• Chad G Rose, PhD

  Auburn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chad G Rose, PhD

CONTACT

8655672205; chadgrose@auburn.edu

Michael E Zabala, PhD

CONTACT

(334) 844-4916; zabalme@auburn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 16 participants will be recruited (8 pre-neuropathic, 8 neuropathic) to evaluate device feasibility through 10 sessions spread over 14 days.

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: March 22, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 1, 2025
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will become available no later than 1 year after conclusion of the study, and for at least three years after the conclusion of the study.
• Access Criteria: PI Approval.

Locations

US (1)