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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Painful Diabetic Neuropathy With Diet, a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT07509671
- Acronym / sponsor ID
- 2102531
- Keywords
- painful, diabetic, neuropathy, peripheral neuropathy, diabetes, diabetes type 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet arm | Experimental | Other: DietThis is a whole food plant-based diet that excludes meat, dairy, eggs and oil |
| medical managment | Experimental | Other: Medical managementThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- Potential causes of neuropathy other than type II diabetes mellitus (as listed below)
- type I diabetes
- vitamin B12 deficiency
- folate deficiency
- thyroid dysfunction,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietAlso: Plant-based dietPlant-based diet | Other | Diet arm |
| Medical managementMedication optimization | Other | medical managment |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: 2 months
Numerical Rating Scale (NRS) is a 0-10 pain score with 0 being no pain and 10 being the worst pain ever.
Average pain on Numerical Rating Scale (NRS)
Time frame: 2 months
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.
≥50% improvement of pain
Time frame: 2 months
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.
≥75% improvement of pain
Time frame: 2 months
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.
16 secondary outcomes
Worst Pain Score on Numerical Rating Scale (NRS)
Time frame: 2 months
Numbness location
Time frame: 2 months
Sleep
Time frame: 2 months
Diabetes medication
Time frame: 2 months
Pain medication
Time frame: 2 months
% pain improvement
Time frame: 2 months
% numbness improvement
Time frame: 2 months
Increased function
Time frame: 2 months
Compliance with diet
Time frame: 2 months
Global impression of change
Time frame: 2 months
Weight
Time frame: 2 months
Blood pressure
Time frame: 2 months
Heart Rate
Time frame: 2 months
Creatinine lab level
Time frame: 2 months
Lipid levels
Time frame: 2 months
Hemoglobin A1c
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- BackgroundStorz MA, Küster O. Plant-based diets and diabetic neuropathy: A systematic review. Lifestyle Med. 2020; 1:e6. https://doi.org/10.1002/lim2.6
- Background: PubMed 39415400Guest 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.
- Background: PubMed 26011582Bunner 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.
- BackgroundCrane 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William J Beckworth, MD (828-654-8546, william.beckworth.md@adventhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07509671, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.