Painful Diabetic Neuropathy (PDN)NCT07509671
The Treatment of Painful Diabetic Neuropathy With Diet
A study testing Diet and Medical management in people with Painful Diabetic Neuropathy (PDN) and Peripheral Neuropathy With Type 2 Diabetes, run by AdventHealth at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy (PDN), Peripheral Neuropathy With Type 2 Diabetes, Vegan Diet
- What is being tested?
- Diet and Medical management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2024to 28 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- autoimmune disorders
- inflammatory disorders
- HIV/AIDS
- exposure to metals or toxins
- multiple myeloma,
- moderate to severe lumbar stenosis with neurogenic claudication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AdventHealth Hendersonville
Hendersonville, North Carolina, 28759
Mary Stanford, Clinical Research Coordinator, 828-654-8546, mary.stanford@adventhealth.com
William J Beckworth, MD
About this study
Official title: The Treatment of Painful Diabetic Neuropathy With Diet, a Randomized-controlled Trial
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.
Read the detailed description
The primary objective of this study is to determine whether dietary modification can improve symptoms of painful diabetic neuropathy (PDN) in a randomized controlled trial.
This will be a prospective, randomized controlled study comparing a dietary intervention with conventional medical management over a two-month period. Participants assigned to the conventional management group will have the option to cross over to the dietary intervention after two months, with additional outcomes assessed following crossover.
The dietary intervention is based on a prior case series demonstrating improvement in PDN with a whole-food, plant-based diet excluding all animal products and added oils. Participants will eliminate meat (red and white), dairy, eggs, and added oils. Those in the dietary group will also be encouraged to attend an optional cooking class to support adherence.
Conventional medical management will consist of optimized pharmacologic therapy, including antiepileptic agents (gabapentin or pregabalin), serotonin-norepinephrine reuptake inhibitors (e.g., duloxetine), tricyclic antidepressants, and over-the-counter options such as alpha-lipoic acid. Medications will be titrated to maximize pain relief while minimizing adverse effects.
This study will be conducted without external funding.
- Being tested
- Diet, Medical management
- Keywords
- painful, diabetic, neuropathy, peripheral neuropathy, diabetes, diabetes type 2
- Medical subject headings
- Diabetic Neuropathies, Pain, Peripheral Nervous System Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Also called Plant-based diet
Plant-based diet
Medical managementOther
Medication optimization
| Study group | Role | What they receive |
|---|---|---|
| Diet arm | Experimental | This is a whole food plant-based diet that excludes meat, dairy, eggs and oil Receives: Other: Diet |
| medical managment | Experimental | This approach reflects standard pharmacologic management of diabetic peripheral neuropathy. Commonly used medications include antiepileptic agents (gabapentin, pregabalin), serotonin-norepinephrine reuptake inhibitors (e.g., duloxetine), tricyclic antidepressants (e.g., amitriptyline, nortriptyline), and over-the-counter options such as alpha-lipoic acid and turmeric. Receives: Other: Medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS) is a 0-10 pain score with 0 being no pain and 10 being the worst pain ever.
Measured: 2 months
Average pain on Numerical Rating Scale (NRS)
Patient will be asked what his or her "average" pain has been over the last 3 days. This will be on the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever.
Measured: 2 months
≥50% improvement of pain
Patient will be asked if his or her average pain over the past 3 days is ≥50% better than baseline pain. This will be comparing the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever.
Measured: 2 months
≥75% improvement of pain
Patient will be asked if his or her average pain over the past 3 days is ≥75% better than baseline pain. This will be comparing the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever.
Measured: 2 months
Secondary outcomes (16)
Worst Pain Score on Numerical Rating Scale (NRS)
Patient will be asked what his or her worst pain is on a daily basis using the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever.
Measured: 2 months
Numbness location
Patient asked the following:
How far up does your numbness go in both lower extremities: (circle one):
- Toes
- Mid foot
- Entire foot
- Ankle
- Mid calf
- Knee
Measured: 2 months
Sleep
Patient is asked the following questions.
How is your sleep? Circle one: good moderate poor
- How many hours are you sleeping a night? ___________________
- Is your sleep improved since the start of study? ______________ (yes or no)
Measured: 2 months
Diabetes medication
Patient is asked:
List your diabetes medications and doses.
Measured: 2 months
Pain medication
Patient is asked the following question. List your pain medications and doses.
Measured: 2 months
% pain improvement
Patient is asked:
What percentage of has your pain improved compared to the start of the study? ____________ (0% = no change to 100% complete relief of pain)
Measured: 2 months
% numbness improvement
What percent is your numbness improved compared to baseline? (0% = no improvement, 100% complete improvement)
Measured: 2 months
Increased function
Have you been able to increase your function (walking, getting around, steadiness on feet)? _________ (yes or no)
Measured: 2 months
Compliance with diet
If you are in the diet group, how compliant have you been with your diet? Chose one:
- 0% (not compliant at all)
- 25%
- 50%
- 75%
- 90%
- 100% (completely compliant at all times)
Measured: 2 months
Global impression of change
Rate your global impression of change of your diabetic neuropathy (chose one):
- Very much improved
- Much improved
- Moderately improved
- Minimally improved
- No change
- Worse
- Much worse
- Very much worse
Measured: 2 months
Weight
Weight in pounds measured at baseline and two months. This is measured in clinic.
Measured: 2 months
Blood pressure
Number of participants with abnormal blood pressure based off the 2017 American College of Cardiology / American Heart Association Guidelines.
Measured: 2 months
Heart Rate
Number of participants with abnormal heart rate (outside of normal 60-100/min)
Measured: 2 months
Creatinine lab level
Number of participants with abnormal creatinine lab level (above 1.3 for males, 1.1 for females) and correlating with estimated glomerular filtration rate which is based off creatinine, age and sex. Kidney function will be based on the National Kidney Foundation guidelines (KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease).
Measured: 2 months
Lipid levels
Percentage of patients with abnormal lipid levels based on the American Heart Association's cholesterol guidelines and lipid reference values.
Measured: 2 months
Hemoglobin A1c
Percent of patients with abnormal hemoglobin A1c. Abormal values are based on American Diabetes Association (normal <5.7, pre-diabetes 5.7-6.4, diabetes ≥6.5).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start23 Apr 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Painful Diabetic Neuropathy (PDN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509671
- Sponsor's protocol ID
- 2102531
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Storz MA, Küster O. Plant-based diets and diabetic neuropathy: A systematic review. Lifestyle Med. 2020; 1:e6. https://doi.org/10.1002/lim2.6
Guest NS, Raj S, Landry MJ, Mangels AR, Pawlak R, Senkus KE, Handu D, Rozga M. Vegetarian and Vegan Dietary Patterns to Treat Adult Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Adv Nutr. 2024 Oct;15(10):100294. doi: 10.1016/j.advnut.2024.100294. Epub 2024 Sep 30.
PubMed 39415400Bunner AE, Wells CL, Gonzales J, Agarwal U, Bayat E, Barnard ND. A dietary intervention for chronic diabetic neuropathy pain: a randomized controlled pilot study. Nutr Diabetes. 2015 May 26;5(5):e158. doi: 10.1038/nutd.2015.8.
PubMed 26011582Crane M, Sample C. Regression of diabetic neuropathy with total vegetarian (vegan) diet. Journal of Nutritional Medicine. 1994;4(4):431-439. https://doi.org/10.3109/13590849409003592.