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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline Pain Assessment

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

Find a Location

Who is running the clinical trial?

Auburn UniversityLead Sponsor

72 Previous Clinical Trials

14,387 Total Patients Enrolled

Chad G Rose, PhDPrincipal InvestigatorAuburn University

Media Library

Non-pharmacological Heat, Pressure, and Vibration (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05414968 — N/A

Diabetic Neuropathy Research Study Groups: Pilot Feasibility Arm

Diabetic Neuropathy Clinical Trial 2023: Non-pharmacological Heat, Pressure, and Vibration Highlights & Side Effects. Trial Name: NCT05414968 — N/A

Non-pharmacological Heat, Pressure, and Vibration (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05414968 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still capacity to join this research initiative?

"Entries on clinicaltrials.gov demonstrate that enrolment for this trial is in progress, which began shortly after its posting date of March 22nd 2023 and was most recently updated August 2nd 2023."

Answered by AI

How many participants are currently enrolled in this medical experiment?

"Affirmative. The details hosted on clinicaltrials.gov demonstrate that this medical trial, first posted in March of 2023, is actively seeking participants. Specifically, the study necessitates 16 patients at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Novel Non-Pharmacological Treatment of Diabetic Neuropathy

Chad Rose 2023. "A Novel Non-Pharmacological Treatment of Diabetic Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05414968.

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