Non-Pharmacological Therapy for Diabetic Neuropathy

N/A

Recruiting

Led By Chad G Rose, PhD

Research Sponsored by Auburn University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after each session (up to 30 minutes)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a non-medicine device can reduce pain, improve quality of life and prevent deaths from diabetes nerve damage. 16 participants with/without diabetes will try it over 10 days. Results will show if it works.

Who is the study for?

This trial is for people who have had type 2 diabetes for at least 5 years and can show lab histories of their blood sugar control. It's not suitable for those with other diseases like vascular disease or an ankle-brachial index (ABI) less than 0.9, which could affect the results.

What is being tested?

The study tests a new device that uses heat, pressure, and vibration as a treatment to improve life quality in diabetic neuropathy patients. There will be two groups: one pre-neuropathic and one neuropathic diabetic group; both receive the same non-drug treatment over ten sessions.

What are the potential side effects?

Since this is a non-pharmacological intervention focusing on heat, pressure, and vibration therapy, there are no drug-related side effects expected. However, participants may experience discomfort or skin irritation from the device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after each session (up to 30 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after each session (up to 30 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after each session (up to 30 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline Pain Assessment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pilot Feasibility ArmExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out