250 Clinical Trials for Various Conditions
The study is a single-center, randomized, participant- and observer-masked, human-subjects, post-market clinical pilot study to investigate the use of ultrasound-guided percutaneous cryoneurolysis to treat diabetic neuropathy of the foot. A prolonged nerve block may be provided by freezing the nerve using a technique called "cryoneurolysis". With cryoneurolysis and ultrasound machines, a small needle-like "probe" may be placed through anesthetized skin and guided to the target nerve to allow freezing. The procedure takes about 6 minutes for each nerve, involves little discomfort, has no systemic side effects, and cannot be misused or become addictive. Participants will be randomly allocated to one of two possible treatments groups: cryoneurolysis (experimental) or sham (control). The primary outcome measure is the change in pain on the neuropathic pain scale from baseline 1 month following the procedure.
Peripheral arterial disease (PAD) affects over 230 million adults worldwide and is a highly morbid, costly, and disabling condition. Ischemic leg pain drives disability in PAD patients and results from oxygen supply-demand mismatch, autonomic dysfunction, and muscle breakdown. This leg pain, which is unresponsive to traditional pharmacotherapy, limits the patient's tolerance to exercise, which is an important disease-modifying intervention. Spinal cord stimulation is a well-established therapy for medically intractable pain, including painful diabetic neuropathy (PDN) and ischemic pain, but is not part of the standard-of-care for PAD despite limited promising clinical data. Early studies used first-generation, tonic stimulation devices, but with these it was impossible to perform sham-controlled trials to test the treatment. Since then, new types of waveform treatments, including high-frequency spinal cord stimulation (SCS), have been shown to be more effective in the treatment of intractable pain. While high-frequency SCS is approved for PDN treatment, it has never been tested in the treatment of claudication pain from PAD. This study will enroll up to 15 participants between the ages of 19 and 89 who have PAD and PDN and are successfully implanted with a permanent SCS. Twelve weeks after SCS implantation, participants will receive two weeks of stimulation and two weeks of sham intervention, in random starting order. Blood flow, blood pressure, skin oxygen levels, and participant reported pain int the lower extremities will be assessed before SCS implantation, 12 weeks after SCS implantation and during each of the treatment periods. Participants will also complete a quality of life survey at the same time points. Comparisons of these measurements with the baseline and post-implantation measurements to determine the effects of SCS.
This study aims to demonstrate treatment outcomes of Painful Diabetic Neuropathy (PDN) patients treated with BurstDRTM Spinal Cord Dorsal Column Stimulator (SCS) along with conservative medical management per standard of care.
The 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).
The 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.
Compare Axon Therapy plus conventional medical management (CMM) to Sham plus CMM in reducing neuropathic pain in patients with painful diabetic neuropathy (PDM).
The 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.
The purpose of this research is to compare the effectiveness of providing dietary education to complement Intraneural Facilitation® Therapy (INF® Therapy) (a physical therapy technique being evaluated that may help improve circulation) versus INF® Therapy only in adults with a type of neuropathy called distal symmetric polyneuropathy (DSPN).
Sensorimotor neuropathy (SMN) and cardiovascular autonomic neuropathy (CAN) are the most common complications of type 2 diabetes (T2D). SMN affects \~30% of people with T2D and CAN \~20%. SMN causes pain, impairs and limits physical activity, and increases the risk for physical disability, complications (such as foot ulcerations), and premature mortality. Moreover, both motor and sensory nerve function are important regulators of muscle function; impaired myofiber innervation causes myofiber loss, muscle fat infiltration, and increases the risk of age-associated sarcopenia and falls. CAN often goes unrecognized because it presents with non-specific symptoms, such as resting tachycardia and fixed heart rate, exercise intolerance, and orthostatic hypotension. However, CAN is a serious problem because it increases the risk for cardiovascular events and mortality several-fold. Both SMN and CAN have long been considered a consequence of T2D, but it is now becoming clear that they precede the diagnosis of T2D and are already detectable in people with prediabetes, especially those with impaired glucose tolerance. Treatments for both SMN and CAN focus on symptom management because there are no effective therapeutics that target the underlying neuropathy. The results from studies conducted in animal models suggest fish oil-derived n-3 polyunsaturated fatty acids (n-3 PUFA) may have therapeutic effects for people with SMN and CAN. The purpose of this proposal is to conduct a randomized controlled trial to test the hypothesis that dietary supplementation with fish oil-derived n-3 PUFA improves sensorimotor and cardiovascular autonomic functions in people with impaired glucose tolerance. Forty 55-80 year old men and women with impaired glucose tolerance (plasma glucose 2 h after a 75 g glucose challenge ≥140 mg/dl) and evidence of SMN (assessed as epidermal nerve fiber density) will be randomized to either receive fish oil-derived n-3 PUFA (4.2 g per day; n=20) or placebo (n=20) for six months. Sensorimotor and cardiovascular autonomic function will be evaluated after three and 6 months of the interventions.
The purpose of the study is to determine the effects of a newer form of non-invasive brain stimulation (called transcranial magnetic stimulation or TMS) as a treatment in patients with painful diabetic neuropathy to examine its effects on their understanding of their pain experience.
The objective of this study is to assess the effect Spinal Cord Stimulators have toward improving vascular changes of diabetes mellitus in patients eligible for SCS placement based on their condition of painful diabetic neuropathy; we will evaluate improving their disability and quality of life, improving micro-circulatory changes induced by Diabetes Mellitus (DM), improving macro-circulatory changes induced by DM and improving arterial stiffness of the vessels of the lower extremity.
Diabetes affects more than 30 million people in the United States and is a leading cause of morbidity. Over 25% diabetics also suffer from debilitating painful diabetic neuropathy in the lower legs and feet. This pain can be severe, difficult to control, and have a significant negative impact on quality of life. Opioid medications have historically been a mainstay of treatment for this pain, despite the risks. As the death toll from the U.S. opioid epidemic continues to rise, the need for quality alternative non-opioid medications to treat pain becomes more urgent. One of these potential medications is Low-Dose Naltrexone (LDN). This drug is reported to work by enhancing the body's natural pain relieving mechanisms and decreases inflammation by targeting specific cells called microglia which have been shown to influence chronic pain. LDN has been shown to be a safe medication with minimal side effects. Its efficacy has been demonstrated in other painful conditions but has never been fully studied for treating painful diabetic neuropathy. The goal of this randomized, placebo-controlled trial is to determine if LDN is effective for treating the pain caused by diabetic neuropathy. LDN's mechanism of action is well suited to treating painful diabetic neuropathy, and LDN shows significant promise as a safe, non-opioid alternative that can decrease pain and improve quality of life for those suffering from this painful condition.
The purpose of this study is to explore the overall safety profile and durability of efficacy of Engensis (VM202) in painful diabetic peripheral neuropathy. All subjects still in follow-up for the VMDN-003 study or who have completed the Day 270 visit within the prior 90 days will be approached to enroll in the long-term safety extension study.
At the current time there is no effective disease modifying therapy for diabetic neuropathy (DN). The proposed study design employs a quantifiable early measure of DN, intraepidermal nerve fiber density (IENFD), allowing for accurate assessment of actual nerve fiber density. Preclinical data supports the use of Niagen® (3-(Aminocarbonyl)-1-β-D-ribofuranosyl-pyridinium chloride - NR) as a potential therapy for diabetic neuropathy. Phase I data indicates safety in humans. This study seeks to investigate the use of Niagen® (NR) as a potential treatment for diabetic neuropathy in subjects with type 2 diabetes mellitus or impaired glucose tolerance over a 6 month period. The endpoint measures in addition to the IENFD with determine changes in clinical and electrophysiological outcomes, quality of life and biochemical measures.
This study evaluates the analgesic effect of Omnitram for the treatment of painful diabetic neuropathy. Each subject with diabetic neuropathy will be treated for four weeks with Omnitram and for four weeks with placebo. The order of the Omnitram and placebo treatment will be random.
The 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.
The study will evaluate whether an experimental medical device that emits a series of brief, intense magnetic pulse will relieve foot pain from Diabetic Neuropathy (DN). The United States Food and Drug Administration (FDA) has approved a similar device for treatment of migraine headaches, but this type of device has not been studied for the treatment of DN.
Investigators propose a placebo controlled, double blinded study to examine efficacy of topical Gelnique 3%TM (3% oxybutynin) daily for 20 weeks) in improving IENF density in type 2 diabetic subjects with established peripheral neuropathy. This site most clearly demonstrated efficacy of topiramate in reversing IENF loss within 18 weeks in our prior study. Subjects will also undergo quantitative sensory testing (QST) and assays of laser Doppler skin blood flow (SkBF), neuropathy total symptom score (NTSS-6), and quality of life (Norfolk QOL-DN), along with standard measures of physiology and fasting blood chemistry. Subjects with IENF loss of between 20-75% of normative values and thus amenable to therapy-induced recovery, will be randomized into placebo (N=30) or active drug (N=30) arms and instructed in how to apply 84 mg Gelnique 3%TM or hydrogel placebo to cover a 2 in2 region of skin adjacent to the initial biopsy site, as per the manufacturers instructions (http://www.gelnique.com/gel3/). Treatment will continue daily for 20 weeks, with monthly phone calls to monitor compliance. After 20 weeks, subjects will return for a second series of measurements and 3 mm skin biopsy from the treated region of skin.
Evaluate the effectiveness of the Provant Therapy System compared to sham on pain sensitivity and nervous system response to various qualities of experimentally induced pain in the upper and lower extremities of subjects with painful peripheral diabetic neuropathy.
This is a double blind, randomized, placebo-controlled study in which a total of 120 patients will be selected from a broad spectrum group of typical Americans (all demographics including various races and both genders as well as ages from 25-90) who have confirmed Type 2 Diabetes Mellitus and suffer from mild to moderate lower extremity Peripheral Neuropathy. All patients will meet inclusion and/or exclusion criteria.
The study will include three (3) phases: Screening Phase, Treatment Phase, and Follow-up Phase. Subjects who qualify to participate will apply study drug to their feet three times daily and will record their daily pain scores using an interactive voice response system (IVRS) during the Treatment Phase for 12 weeks. Approximately 100 adult subjects will be randomized to receive Clonidine Gel or Clonidine Gel Comparator.
The purpose of this study is to determine the safety and efficacy of bilateral intramuscular injections of VM202 versus placebo in the treatment of painful diabetic peripheral neuropathy. A total of 507 of 477 planned participants were randomized in a 2:1 ratio to one of two treatment groups. Note that 500 participants received Investigational product treatment, whereas 7 participants did not receive Investigational product treatment. Treatments - Engensis (VM202) - 336 Engensis of 318 planned participants Control - Placebo (VM202 vehicle) - 164 Placebo of 159 planned participants Randomization were stratified by current use of gabapentin and/or pregabalin.
Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their 12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this study and receive active study drug in an open-label manner.
Peripheral neuropathy is a common complication of diabetes, and one of the strongest determinants of reduced health-related quality of life among people with diabetes. Neuropathy frequently presents with painful symptoms, activity limitation, insomnia, fatigue, and depressive symptoms. Anti-convulsants and tricyclic anti-depressants provide at least moderate pain relief for 25-50% of patients with painful diabetic neuropathy (PDN), but often decrease other domains of quality of life through adverse effects, such as dry mouth, dizziness, nausea, drowsiness, and urinary problems. Effective, non-pharmaceutical approaches for PDN are needed, particularly for low income and racial/ethnic minorities who are at highest risk of diabetes and related complications. Acupuncture is a promising treatment for PDN, but evidence is limited. To address the significant public health need related to pain management among underserved people with diabetes, this study proposes an innovative, group-based model of acupuncture for PDN at an urban safety net hospital. Sixty patients who have PDN will be enrolled and randomized to one of three arms: (a) usual care combined with 12 weeks of group acupuncture twice weekly, (b) usual care combined with 12 weeks of group acupuncture once weekly, or (c) usual care alone (20 in each group). The aims of the study are to determine the feasibility of group acupuncture for PDN among underserved patients with diabetes; to evaluate the preliminary treatment effects of group acupuncture on pain, health-related quality of life, depressive symptoms, sleep disturbance, nerve conduction velocity, and protective sensation; and to determine the optimal frequency of acupuncture treatments. The investigators hypothesize that compared to patients receiving usual care alone, patients who undergo weekly group acupuncture treatments will have: 1. decreased pain intensity 2. improved health-related quality of life 3. improved sural nerve conduction velocity
The purpose of the study is to determine whether clonidine gel is an effective treatment for reducing the pain associated with painful diabetic neuropathy.
The purpose of this study is to assess whether, in individuals with diabetic neuropathy, a low-fat, vegan diet in combination with a vitamin B12 supplement improves pain, sensation and other subjective symptoms, more effectively than a vitamin B12 supplement with no diet changes. The principal measure is pain as measured by the following assessment tools: Michigan Neuropathy Screening Instrument, Norfolk Quality of Life Questionnaire, Neuropathy Impairment Score - Lower Limbs, Neuropathy Total Symptom Score, Neuropathy Pain Scale, McGill Pain Questionnaire and Global Impression Scale. The study duration is 20 weeks. This study also examines the effects of a low-fat, vegan diet on mood, using the Center for Epidemiologic Studies Depression Scale-Revised, and the Beck Depression Inventory.
Type 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.
To evaluate the effectiveness of DA-9801 at 300mg, 600mg, 900mg and placebo, in reducing pain in subjects with diabetic neuropathic pain compared to their baseline values.
The difference between active treatment and placebo in a clinical trial of an analgesic appears to depend on a variety of factors other than the actual efficacy of the drug itself, including various aspects of study design and conduct. One potential such factor is how information about the study is presented to research staff and patients. The purpose of this study is to examine the impact of different presentations of information on the difference between pregabalin and placebo observed in a clinical trial in patients with painful diabetic neuropathy.
The purpose of this study is to assess whether, in individuals with diabetic neuropathy, a low-fat, vegan diet in combination with a vitamin B12 supplement improves pain, sensation and other subjective symptoms, more effectively than a vitamin B12 supplement with no diet changes. The principal measure is pain as measured by the following assessment tools: Michigan Neuropathy Screening Instrument, Norfolk Quality of Life Questionnaire, Neuropathy Impairment Score - Lower Limbs, Neuropathy Total Symptom Score, Neuropathy Pain Scale, McGill Pain Questionnaire and Global Impression Scale. The study duration is 20 weeks. This study also examines the effects of a low-fat, vegan diet on mood, using the Center for Epidemiologic Studies Depression Scale-Revised, and the Beck Depression Inventory.