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New treatment option for Painful Diabetic Neuropathy (PDN)
Official title The Treatment of Painful Diabetic Neuropathy With Diet
ClinicalTrials.gov ID: NCT07509671
What this study is testing
- What it's testing
- The purpose of this clinical trial is to determine whether targeted nutritional changes can improve symptoms of painful diabetic neuropathy. Impaired blood flow to peripheral nerves-resulting in reduced oxygen delivery and subsequent nerve injury-is a well-established contributor to neuropathy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Definitive diagnosis of type II diabetes mellitus (HgA1c ≥ 6.5) or pre-diabetes (HgA1c 5.7-6.4)
- objective documentation of peripheral neuropathy on EMG/NCS testing defined as a sural-to-radial amplitude ratio of 0.21 or less
- presence of painful neuropathy in addition to decreased sensation
- with pain rated ≥4/10 on a 0-10 numerical rating scale (NRS)
- age 18 years or older
You likely can't join if
- Potential causes of neuropathy other than type II diabetes mellitus (as listed below)
- type I diabetes
- vitamin B12 deficiency
- folate deficiency
- thyroid dysfunction,
- other nutritional deficiencies
See the full eligibility criteria
- Definitive diagnosis of type II diabetes mellitus (HgA1c ≥ 6.5) or pre-diabetes (HgA1c 5.7-6.4)
- objective documentation of peripheral neuropathy on EMG/NCS testing defined as a sural-to-radial amplitude ratio of 0.21 or less
- presence of painful neuropathy in addition to decreased sensation
- with pain rated ≥4/10 on a 0-10 numerical rating scale (NRS)
- age 18 years or older
- ability to provide informed consent
- ability to attend follow-up visits.
- Potential causes of neuropathy other than type II diabetes mellitus (as listed below)
- type I diabetes
- vitamin B12 deficiency
- folate deficiency
- thyroid dysfunction,
- other nutritional deficiencies
- autoimmune disorders
- inflammatory disorders
- HIV/AIDS
- exposure to metals or toxins
- multiple myeloma,
- moderate to severe lumbar stenosis with neurogenic claudication
The study team makes the final eligibility decision.
Where it's taking place
- Hendersonville, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hendersonville, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.