Actively Recruiting
The Treatment of Painful Diabetic Neuropathy With Diet
Led by AdventHealth · Updated on 2026-04-30
40
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Prior studies have shown that a whole-food, plant-based diet without added oils can improve or even reverse arterial disease, suggesting a potential mechanism for enhancing nerve perfusion and function. This study is a randomized controlled trial comparing a whole-food, plant-based diet with standard pharmacologic management for painful diabetic neuropathy.
CONDITIONS
Official Title
The Treatment of Painful Diabetic Neuropathy With Diet
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with a sural-to-radial amplitude ratio of 0.21 or less
- Presence of painful neuropathy along with decreased sensation
- Pain rated 4 or higher on a 0-10 Numerical Rating Scale (NRS)
- Age 18 years or older
- Ability to provide informed consent
- Ability to attend follow-up visits
You will not qualify if you...
- Neuropathy caused by conditions other than type II diabetes mellitus
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AdventHealth Hendersonville
Hendersonville, North Carolina, United States, 28759
Actively Recruiting
Research Team
W
William J Beckworth, MD
CONTACT
M
Mary Stanford, Clinical Research Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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