Non-drug treatment for diabetic nerve pain
A Novel Non-Pharmacological Treatment of Diabetic Neuropathy
This study is testing a new device that uses pressure, heat, and vibration to see if it can help people with diabetic nerve pain feel better and improve their foot sensation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Auburn University Academic / other |
| Locations | 1 site (Auburn, Alabama) |
| Trial ID | NCT05414968 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a non-pharmacological intervention for diabetic peripheral neuropathy (DPN) to enhance the quality of life for individuals with diabetes. It will assess the feasibility of a device that combines pressure, heat, and vibration to improve foot sensation and reduce symptoms associated with DPN. Sixteen participants, divided into pre-neuropathic and neuropathic diabetic groups, will undergo a 45-minute intervention over ten sessions within a two-week period. The effectiveness will be measured by changes in pain levels before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with type 2 diabetes for at least five years who may be experiencing symptoms of diabetic peripheral neuropathy.
Not a fit: Patients with other diseases affecting results or significant vascular disease may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of diabetic neuropathy without the need for pharmacological treatments.
How similar studies have performed: While there is limited research on similar non-pharmacological approaches, this study explores innovative methods that have not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Auburn, Alabama
- Auburn University — Auburn, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Chad G Rose, PhD — Auburn University
- Study coordinator: Chad G Rose, PhD
- Email: chadgrose@auburn.edu
- Phone: 8655672205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.