An interventional study of Diet and Medical management in Painful Diabetic Neuropathy (PDN), Peripheral Neuropathy With Type 2 Diabetes and Vegan Diet, sponsored by AdventHealth. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by AdventHealth · Not applicable, Interventional, and Treatment
Among 158 studies in Diabetic Neuropathies with a site in United States — 12 open to participants now, 17 under way, none of them phase 3. Diabetic Neuropathies · United States.
Among the 158 studies in Diabetic Neuropathies with a site in United States, this one is the 108th largest by planned enrollment of the 145 interventional ones that give a count, is one of 5 that started in 2024, is one of 46 with no phase, reaches primary completion later than 15 of the 16 other live ones, and was the 157th registered.
538 studies on the registry are indexed under Diabetic Neuropathies; 80 are open to participants now.
Browse Diabetic Neuropathies studies →12 of the 158 studies in Diabetic Neuropathies with a site in United States are open now. Recruiting first, the newest first:
Florida A&M University · Sites in United States
Carilion Clinic · Sites in United States
C5 Biomedical · Sites in United States
University of Nebraska · Sites in United States
Axolotl Biologix · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 52 Diabetic Neuropathies studies recruiting now, 21 (40%) set no upper age limit and 24 (46%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
158 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 58 · Phase 3 26 · Phase 4 18
First in 1993; this study’s year is marked. 5 started in 2024.
This study's planned enrollment of 40 is below the median of 68 across 448 interventional studies indexed under Diabetic Neuropathies.
Median enrollment 91 across the 145 interventional studies, 144 across the 11 observational. Of the 122 that completed or were terminated, 46 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
91 of 158 have an industry lead sponsor. The 10 most frequent:
AdventHealth is the lead sponsor of 113 studies on the registry; 22 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
AdventHealth has 1 study filed under Diabetic Neuropathies — fewer than ten, so there is no comparison to draw.
11 of the studies in Diabetic Neuropathies with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06674980C5 BiomedicalClinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs | 2026-11-22 |
| NCT04678895Dartmouth-Hitchcock Medical CenterLow-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy | 2026-12 |
| NCT07298408Florida A&M UniversityCannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study | 2026-12-31 |
| NCT07250828TriCity Research CenterEfficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy | 2027-01 |
| NCT06480786University of NebraskaSCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease | 2027-01 |
Among the 158 studies in Diabetic Neuropathies with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a whole food plant-based diet that excludes meat, dairy, eggs and oil
Other: Diet
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.
Other: Medical management
Plant-based diet
Also known as: Plant-based diet
Medication optimization
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 months
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.
Time frame: 2 months
Numbness location
Patient asked the following: How far up does your numbness go in both lower extremities: (circle one): 1. Toes 2. Mid foot 3. Entire foot 4. Ankle 5. Mid calf 6. Knee
Time frame: 2 months
Sleep
Patient is asked the following questions. How is your sleep? Circle one: good moderate poor 1. How many hours are you sleeping a night? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 2. Is your sleep improved since the start of study? \_\_\_\_\_\_\_\_\_\_\_\_\_\_ (yes or no)
Time frame: 2 months
Diabetes medication
Patient is asked: List your diabetes medications and doses.
Time frame: 2 months
Pain medication
Patient is asked the following question. List your pain medications and doses.
Time frame: 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)
Time frame: 2 months
% numbness improvement
What percent is your numbness improved compared to baseline? (0% = no improvement, 100% complete improvement)
Time frame: 2 months
Increased function
Have you been able to increase your function (walking, getting around, steadiness on feet)? \_\_\_\_\_\_\_\_\_ (yes or no)
Time frame: 2 months
Compliance with diet
If you are in the diet group, how compliant have you been with your diet? Chose one: 1. 0% (not compliant at all) 2. 25% 3. 50% 4. 75% 5. 90% 6. 100% (completely compliant at all times)
Time frame: 2 months
Global impression of change
Rate your global impression of change of your diabetic neuropathy (chose one): 1. Very much improved 2. Much improved 3. Moderately improved 4. Minimally improved 5. No change 6. Worse 7. Much worse 8. Very much worse
Time frame: 2 months
Weight
Weight in pounds measured at baseline and two months. This is measured in clinic.
Time frame: 2 months
Blood pressure
Number of participants with abnormal blood pressure based off the 2017 American College of Cardiology / American Heart Association Guidelines.
Time frame: 2 months
Heart Rate
Number of participants with abnormal heart rate (outside of normal 60-100/min)
Time frame: 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).
Time frame: 2 months
Lipid levels
Percentage of patients with abnormal lipid levels based on the American Heart Association's cholesterol guidelines and lipid reference values.
Time frame: 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).
Time frame: 2 months
Plan to share: Yes — All IPD that underlie results in a publication.
Supporting information: Study protocol, Informed consent form
Time frame: From start to finish. Anticipated finish date for data collection is December 2027 and publication by mid 2028
Access criteria: Access criteria will be based on those who are involved with the study or have oversight of study. This will include principle investigators, research coordinators, statisticians, IRB, research institute or any monitoring bodies.
Started Apr 2024 (actual). Primary completion is estimated for Dec 2027, 44 months after the start.
Of 137 non-industry interventional studies with no phase under Diabetic Neuropathies, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 44 months is above that.
Counting every sponsor, half of 152 studies reached it within 12 months; a quarter within 6 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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