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28 Diabetic Neuropathy Trials
Power is an online platform that helps thousands of Diabetic Neuropathy patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Suzetrigine for Diabetic Neuropathy
Chicago, IllinoisThe purpose of this study is to evaluate the long-term safety and tolerability of SUZ and long-term effectiveness of SUZ in treating pain associated with DPN.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:18 - 80
Sex:All
300 Participants Needed
Suzetrigine for Diabetic Neuropathy
Chicago, IllinoisThe purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Sensory Abnormalities, Others
1100 Participants Needed
NRD135SE.1 for Peripheral Neuropathy
Flossmoor, IllinoisThis trial tests a daily pill called NRD135S.E1 for people with painful nerve damage from diabetes. The study will see if taking this pill for a few months can safely reduce their pain. Researchers aim to understand how well the drug works and if it is safe to use.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
122 Participants Needed
VX-993 for Diabetic Neuropathy
Flossmoor, IllinoisThe purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Painful Neuropathy, Cardiac Dysrhythmias, Atherosclerotic Event, Others
Must Not Be Taking:Anti-arrhythmics
300 Participants Needed
ISA-Specific Therapy for Diabetic Nerve Pain
Flossmoor, IllinoisThis trial tests several treatments for nerve pain in diabetic patients to identify effective therapies for reducing this type of pain.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
122 Participants Needed
LX9211 for Diabetic Neuropathy
Berwyn, IllinoisThis trial is testing a new drug called LX9211 to see if it can reduce nerve pain in people with diabetes. The drug works by blocking pain signals in the nerves. Researchers want to find out if it is more effective than other treatments. A similar drug was previously tested for similar conditions but its development was halted due to safety concerns.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
416 Participants Needed
LY3556050 for Diabetic Peripheral Neuropathic Pain
Chicago, IllinoisThis trial is testing a new drug called LY3556050 to see if it can help reduce nerve pain in people with diabetes. The study will last several months and will compare the effects of LY3556050 to another treatment. The goal is to determine if LY3556050 is safe and effective for treating diabetic nerve pain.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Cancer, HIV, Substance Use Disorder, Others
410 Participants Needed
Electrical Stimulation for Diabetic Neuropathy Pain
Chicago, IllinoisThe purpose of this study is to assess the effects of Transcranial Direct Current Stimulation (tDCS) in combination with Transcranial ultrasound (TUS) for the treatment of pain and functional limitations in subjects with Diabetic Neuropathic Pain.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:40 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Severe Depression, Neurological Disorders, Others
Must Not Be Taking:Carbamazepine
60 Participants Needed
Multiple Treatments for Chronic Pain
Chicago, IllinoisThis trial is testing different treatments for chronic pain in patients with knee osteoarthritis, chronic low back pain, and diabetic nerve pain. It aims to find effective ways to reduce their chronic pain.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Heart Block, Cancer, Fibromyalgia, Substance Use, Others
10000 Participants Needed
GSK3858279 for Diabetic Neuropathy
Chicago, IllinoisThis is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
145 Participants Needed
RTA 901 for Diabetic Neuropathy
Peoria, IllinoisThis trial is testing a new drug called RTA 901 to see if it can help people with nerve pain caused by diabetes. The drug likely works by calming down the nerves that are causing the pain. The study will compare different doses of the drug to find out which dose works best.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Non-diabetic Neuropathy, Fibromyalgia, Diabetic Foot Ulcer, Others
384 Participants Needed
CagriSema for Diabetic Neuropathy
Springfield, IllinoisThis study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, compared to placebo. Participants will either get an active medicine or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. In this study the active, investigational medicine is called CagriSema. Doctors cannot yet prescribe CagriSema. For each participant, the study will last for about 10 months.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Epilepsy, Fibromyalgia, Others
Must Be Taking:Oral Anti-diabetics, Basal Insulin
134 Participants Needed
Fish Oil + Salsalate for Diabetic Neuropathy
Iowa City, IowaDiabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes, affecting about 50% of patients with diabetes and leading to severe morbidity, poor quality of life, high mortality, and high health care costs. Due to the complex structure and anatomy of the peripheral nervous system, DPN presents with a very broad spectrum of clinical symptoms and deficits, including severe pain, sensory deficits, foot ulcers and amputations. Presently there is no treatment for DPN and even with good blood glucose control DPN develops especially in patients with type 2 diabetes. There is a need to identify effective interventions for DPN. Preclinical studies have provided evidence that the combination of fish oil and salsalate is an effective treatment of DPN. The human subject study to be performed will examine the effect of fish oil with and without salsalate on the blood lipid profile and circulating metabolites of omega-3 polyunsaturated fatty acids (PUFA). Fish oil is an excellent source for the nutrition dependent omega-3 PUFA, primarily eicosapentaenoic acid (EPA; 20:5) and docosahexaenoic acid (DHA; 22:6). These fatty acids are the source of anti-inflammatory metabolites known as resolvin, neuroprotectin and maresin. Preclinical studies have also demonstrated that the metabolites of EPA and DHA are neuroprotective. Furthermore, when fish oil is combined with salsalate the production of these metabolites is increased in vivo. Thus, the investigators hypothesize that fish oil and salsalate will be an effective therapy of DPN. However, prior to doing a formal study of the effect of fish oil + salsalate on DPN there is a need to learn more about what concentration combination will provide the most efficacious effect on the omega-3 index (defined as the sum of EPA and DHA, as a percentage of total fatty acids in red blood cells) and that will safely increase the production of the anti-inflammatory metabolites. These studies will be performed at two sites the University of Iowa (Dr. Yorek) and University of Michigan (Dr. Pop-Busui) by treating human subjects with type 2 diabetes and DPN with either 2g or 4g of fish oil per day (capsules) for 4 months and then adding salsalate 1.5 g or 3g per day (tablets) to the fish oil treatments for an additional 2 months. At baseline and after treatment with fish oil alone and after treatment with the combination of fish oil and salsalate the omega-3 index and levels of circulating omega-3 PUFA metabolites will be determined as primary endpoints. Secondary endpoints will include determination of circulatory inflammatory markers and non-invasive measurements for DPN. The risks to subjects are minimal and are very reasonable in relation to the importance of the knowledge to be gained.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Other Neuropathies, Uncontrolled Hypertension, Organ Transplant, Others
Must Not Be Taking:Anticoagulants, Uricosurics, Lithium, Others
100 Participants Needed
Fish Oil for Diabetic Neuropathy
Iowa City, IowaThis trial is testing whether fish oil supplements can help people with type 2 diabetes who have nerve damage. The study aims to see if fish oil can repair damaged nerves and improve their function. If successful, this could provide a new treatment option for diabetic nerve damage.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:50 - 75
Sex:All
44 Participants Needed
Spinal Cord Stimulator for Diabetic Neuropathy
Ann Arbor, MichiganThe purpose of this post-market study is to evaluate the real-world experience of Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic, intractable leg pain due to painful diabetic neuropathy (PDN). This is a multicenter, prospective, observational global study, that will partner diabetes management teams with pain physicians to provide an interdisciplinary treatment regimen for PDN patients. Outcomes will be assessed via standardized assessments.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Mononeuropathy, Amputation, Large Ulcers, Others
497 Participants Needed
LY3848575 for Neuropathic Pain
Dayton, OhioThe purpose of this study is to evaluate how safe and how well a treatment works compared to placebo for people with nerve pain that begins in their feet and moves up the leg to just below the knee.
Participation may last up to 30 weeks including screening.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Uncontrolled Diabetes, Cancer, Suicidal, Others
450 Participants Needed
Pregabalin + Duloxetine for Peripheral Neuropathy
St. Louis, MissouriThe goal of this clinical trial is to determine whether quantitative sensory testing (QST) can be used to classify participants into pain sub-groups and predict who will respond best to certain pain treatments in participants with painful peripheral neuropathy.
The analgesic effect is evaluated by measuring pain intensity and Patient Global Impression of Change (PGIC).
This study is a 3-period cross-over trial. This means researchers will compare 3 different drugs (pregabalin, duloxetine, and placebo) over a period of 19 weeks.
Participants will:
* Undergo a quantitative sensory testing (QST) exam.
* Provide a blood sample.
* Complete questionnaires on the computer.
* Take the study drug as instructed.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 80
Sex:All
190 Participants Needed
Spinal Cord Stimulation for Peripheral Neuropathy
Columbus, OhioThis is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Comorbidities, Spinal Disease, Coagulopathy, Hemoglobin A1c > 10, Others
Must Be Taking:Gabapentin, Pregabalin
60 Participants Needed
Eptinezumab for Diabetic Neuropathy
Rochester, MinnesotaThe main purpose of this study is to compare the change in pain intensity during treatment with a CGRP monoclonal antibody (eptinezumab) compared with placebo treatment in patients with painful diabetic polyneuropathy (DPN).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
100 Participants Needed
Nerve Stimulation for Diabetic Neuropathy
Cleveland, OhioThis trial aims to help people who have lost a leg by using small devices that send electrical signals to nerves and record muscle activity. These signals help the brain feel sensations from the missing limb, and the muscle data helps control a robotic leg more naturally.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Uncontrolled Diabetes, Vascular Disease, Infections, Obesity, Others
15 Participants Needed
Magnetic Stimulation for Diabetic Neuropathy
Hamilton, OntarioThe aim of this study is to determine whether a 4-week treatment of repetitive transcranial magnetic stimulation (rTMS) can alleviate the symptoms of neuropathy in individuals with diabetic neuropathy. The study will involve using questionnaires, nerve assessments, sensory tests, blood flow measurements, and blood tests to monitor any changes in symptoms after the rTMS intervention.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:20 - 75
Sex:All
20 Participants Needed
Spinal Cord Stimulation for Diabetic Neuropathy
Omaha, NebraskaThe study involves permanent spinal cord stimulator (SCS) placement in participants with peripheral arterial disease (PAD) and painful diabetic neuropathy (PDN). Participants will be between 19 and 89 years old, have diabetes with symptoms of neuropathy, and have a starting pain level of at least 5 cm on a visual pain scale. They must also have PAD, confirmed by an ankle-brachial index under 0.90 or vascular imaging, and experience pain from walking with a pain level of at least 6 cm for at least 3 months. Their Vascular Quality of Life Questionnaire score should be 5.5 or less, and they must be good candidates for SCS.
The study includes initial evaluation visits, follow up after their permanent SCS is placed and optimized 12 weeks in the clinic at this time the study interventions begin and the patient is followed for four weeks; two weeks of stimulation and two weeks of sham intervention in random order, and intervention evaluations. At each follow up visit pain, sensory, functional, vascular, and autonomic outcomes will be assessed, after which patients will return to standard SCS care. The total time for the study intervention is 4 weeks.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:19 - 89
Sex:All
15 Participants Needed
10 kHz Spinal Cord Stimulation for Diabetic Neuropathy
Winston-Salem, North CarolinaThe purpose of this post-market study is to evaluate changes in pain and neurological function with high frequency, 10 kHz spinal cord stimulation (SCS) therapy in patients with chronic, intractable lower limb pain associated with diabetic peripheral neuropathy, a condition known as painful diabetic neuropathy (PDN). This is a multi-center, prospective, randomized controlled study to evaluate improvement in pain and neurological function in PDN patients, with neurological function assessed via objective measures. Patients will be randomized to conventional medical management (CMM) or 10 kHz SCS plus CMM.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22+
Sex:All
143 Participants Needed
Therapeutic Socks for Diabetic Neuropathy
Roswell, GeorgiaDistal symmetric polyneuropathy, also known as diabetic neuropathy, is the most common neurological complication of diabetes and a main cause of morbidity. The condition leads to gradual loss of function of the longest nerve fibers that limits function and decreases quality of life. Symptoms present distally and symmetrically in toes and feet. Symptoms of the neurologic disability include sensory loss, risk of foot ulcers and limb amputations and pain. The condition is not generally considered reversible, and condition management aims to slow progression and prevent complications.
According to estimates from the International Diabetes Federation, diabetic neuropathy affected approximately 425 million people in 2017, with projections indicating a rise to 628 million by 2045. Despite the high prevalence of this condition, it is commonly misdiagnosed and has limited treatment options. There are multiple phenotypes of diabetic neuropathy, with the most common form being distal symmetric sensorimotor polyneuropathy, which is what we will be focusing on in this study.
The proposed study seeks to evaluate the effectiveness of a non-compressive therapeutic socks throughout a 12-week course of rehabilitation for managing distal symmetric polyneuropathy. Outcome measures will be collected at standard intervals and compared with pre-treatment measures to evaluate effectiveness of treatment.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 79
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurodegenerative Conditions, Chronic Pain, Auto-immune Diseases, Others
80 Participants Needed
Biofeedback Gait Training for Diabetic Peripheral Neuropathy
Atlanta, GeorgiaThe purpose of this study is to 1) examine the differences in walking function and movement patterns between individuals with diabetic peripheral neuropathy and healthy adults with no known conditions; 2) examine if receiving feedback on walking form will help change walking patterns; and 3) examine the feasibility, safety, and preliminary effects of walking training with feedback on walking function in individuals with diabetic peripheral neuropathy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:45+
Sex:All
50 Participants Needed
Biofeedback Gait Training for Diabetic Neuropathy
Atlanta, GeorgiaThis study aims to collect data to improve gait function in individuals with Diabetic Peripheral Neuropathy (DPN).
The primary goals are to evaluate:
* Biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN
* Biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN
The participants will be required to complete
* Questionnaires
* Clinical examination
* 3-Dimensional gait analysis on an instrumented treadmill
* Visual and auditory biofeedback on the participant's propulsion and plantar pressure metrics provided by a projector screen during walking
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:45 - 90
Sex:All
25 Participants Needed
Lifestyle Modification for Diabetic Neuropathy
Baltimore, MarylandType 2 diabetes (DM2) affects nearly 20 million people in the United States while impaired glucose regulation (IGR), which includes impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and early diabetes affects a considerably larger but unknown population group. At the current time there is no effective therapy to completely prevent, or reverse neuropathy associated with IGR and this represents a considerable challenge in rehabilitation. There is a particularly strong incentive to prevent IGT and related complications from advancing to DM2. IGR is a growing problem among all older adults and its strong association with many functional limitations, particularly mobility limitations, is not always recognized, even though diabetes-related disability occurs in up to 2/3 of older adults with diabetes and is associated with dependency, poor quality of life, and increased acute and long-term care utilization.
Autonomic dysfunction is a significant problem in subjects with IGT. The Preliminary Data shows that over 90% of subjects with IGT have an abnormal score on questionnaires about autonomic symptoms such as lightheadedness, dry mouth or dry eyes, pale or blue feet, feet that are colder than the rest of the body, decreased sweating in the feet or increased sweating in the hands, nausea or bloating after eating, persistent diarrhea or constipation, or leaking of urine. In addition, patients with IGR have impaired balance control. These factors can increase the risk of falls in affected subjects. A non-randomized and non-controlled study showed that a diet and exercise intervention in patients with diabetes led to an overall improvement in autonomic function. Furthermore, it was shown that standing balance can be improved with a balance intervention program.
However, there are no published studies that assess the effect of an intense physical activity intervention on autonomic function in IGR related neuropathy. This study will test an aerobic exercise and balance intervention in participants with IGR. The investigators will examine if an individually tailored, carefully monitored, Diet, Physical Activity, and Balance Enhancement Program (DPAEP) can improve autonomic function and balance control when compared to patients who receive standard care. Improving balance control and autonomic function can decrease the risk of falls and have a significant effect on the health of participants.
The research is also significant because it will test subjects either before they become diabetic, or at an early stage in their diabetes, thus enhancing the chance of reversing the autonomic neuropathy or balance impairment. Furthermore, the study is designed to test whether improvement in autonomic function and balance is associated with improvement in clinical outcomes, quality of life, and the metabolic state of participants. Thus, the proposed interventions are likely to have a real life impact on participants and their health.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:30 - 80
Sex:All
60 Participants Needed
Non-Pharmacological Therapy for Diabetic Neuropathy
Auburn, AlabamaThe objective of the proposed work is to develop non-pharmacological interventions for diabetic peripheral neuropathy (DPN), to improve quality of life of individuals with diabetes, and reduce the prevalence of opiate prescription, sensation loss, falls, and deaths caused by DPN. To this end, the proposed study will investigate and determine the feasibility of the non-pharmacological intervention device. The feasibility study involves 16 participants, split evenly between pre-neuropathic diabetic and neuropathic diabetic participants. During the study, each group will receive the same 45-minute intervention on 10 days spread over no more than 14 days total. Feasibility will be determined by change in pain assessed before and after intervention.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Vascular Disease, ABI 0.9 Or Less, Others
16 Participants Needed
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Frequently Asked Questions
How much do Diabetic Neuropathy clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Diabetic Neuropathy clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Diabetic Neuropathy trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Diabetic Neuropathy is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Diabetic Neuropathy medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Diabetic Neuropathy clinical trials ?
Most recently, we added Pregabalin + Duloxetine for Peripheral Neuropathy, Spinal Cord Stimulation for Diabetic Neuropathy and CagriSema for Diabetic Neuropathy to the Power online platform.