Recruiting

Diabetic Neuropathy

Sponsor:

Auburn University

Code:

NCT05414968

Conditions

Diabetic Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-pharmacological Heat, Pressure, and Vibration

Study Details

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

Study ID

NCT05414968

Start date

Mar 22, 2023

Status verified date

Aug, 2023

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Pilot Feasibility Arm

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.

Interventions

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.

Primary outcome measure

  • Change from Baseline Pain Assessment [ Time Frame: immediately after each session (up to 30 minutes) ]

Central Contacts and Locations

Central contacts

Chad G Rose, PhD

8655672205chadgrose@auburn.edu

Michael E Zabala, PhD

(334) 844-4916zabalme@auburn.edu

Locations

Auburn University

Recruiting

Auburn, Alabama, United States, 36849

Contacts

Chad G Rose, PhD

334-844-3401chadgrose@auburn.edu

More Information

Sponsor

Auburn University

Last update posted

Aug 4, 2023

Last verified

Aug, 2023

Keywords

  • nonpharmacological intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Auburn University on 2023-08-04.