WithdrawnNot Applicable

Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy

Stopped: The PI resigned and the recruitment had not been started.

United States0Started 2021-09-01

Plain-language summary

The purpose of this study is to characterize the changes in peripheral nerve functions (sensory and motor) in patients with diabetic peripheral neuropathy, and examine the relations between the changes in nerve functions and changes in pain and mobility using focal vibration.

Who can participate

Age range

45 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of diabetes for at least one year; * Diabetic peripheral neuropathy as defined by failure to sense the 5.07 (10g) monofilament test in one or more of the six sites tested; * Age 45-80 years old; * Able to ambulate independently without assistive devices (e.g., walker or crutches) for 30 feet; * No evidence of neurological (other than peripheral neuropathy) or orthopedic conditions; * Able to understand English instructions; * Have normal or corrected vision. Exclusion Criteria: * With other non-diabetic causes of neuropathy by history; * Symptomatic peripheral vascular disease, joint pain, swelling and/or limited range of motion in the lower extremities that interfere with walking; * Other systemic or local diseases that could interfere with walking assessment * Amputation in the lower extremities; * Clinically diagnosed with dementia greater than mild (screened using Montreal Cognitive Assessment (MOCA) \<24)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in CMAP

Timeframe: Change from Baseline CMAP measures every 2 weeks for up to 6 weeks

Changes in NCV

Timeframe: Change from Baseline NCV measures every 2 weeks for up to 6 weeks

Changes in SNAP

Timeframe: Change from Baseline SNAP measures every 2 weeks for up to 6 weeks

Changes in BPI-DPN

Timeframe: Change from Baseline BPI-DPN scores every 2 weeks for up to 6 weeks

Changes in TUG

Timeframe: Change from Baseline TUG scores every 2 weeks for up to 6 weeks

Changes in NTSS-6

Timeframe: Change from Baseline NTSS-6 scores every 2 weeks for up to 6 weeks

Changes in NSS

Timeframe: Change from Baseline NSS scores every 2 weeks for up to 6 weeks

Trial details

NCT IDNCT05041816

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-31

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathy trials