Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy...
PainPain Syndrome10 moreOver the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the long term efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with pain disorders due to diabetic polyneuropathy. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to diabetic polyneuropathy.
Peer Support for Patients With Diabetic Foot Ulcers
Diabetic Foot UlcerDiabetic Wound5 moreThe objective of the study is to develop a peer support program that helps improve ulcer care in patients with a diabetic foot ulcer (DFU).Diabetes, peripheral arterial disease (PAD), foot ulceration, and subsequent amputation are unevenly patterned in terms of racial/ethnicity, socioeconomic status, health insurance, and geographic area. The project will identify opportunities to reduce health disparities among economically marginalized patients regarding DFU outcomes.
Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy
Diabetic Peripheral NeuropathyDiabetic Neuropathies2 moreDiabetic neuropathy (DN) is the most common complication of diabetes, affecting almost 50% of people with diabetes over the course of their lives. Symptoms vary from numbness to burning, aching and hypersensitivity in the lower limbs, indicative of sensory nerve loss. Motor neurons can also be affected, leading to muscle weakness and mobility issues, thus preventing patients from engaging in daily routines. Further sequelae include foot ulceration and Charcot neuroarthropathy, which are risk factors for lower limb amputation and mortality. In the United Kingdom, the annual costs of DN alone exceed £300 million, with further complications expected to cost an additional £1 billion. Currently, management strategies for DN focus on prevention and pain management. Neuromuscular electrical stimulation (NMES) is a novel nonpharmacological intervention for people with DN. NMES is the application of electrical impulses which are of sufficiency intensity to improve artificial contraction of the muscle tissue and may help with DN by improving nerve conductivity through direct stimulation of the nerves.
StimRouter Registry Clinical Protocol
Chronic PainPeripheral Neuropathy5 moreThis Registry study will prospectively evaluate the long-term effectiveness, safety, and tolerability of the StimRouter Neuromodulation System, along with evaluating the technical performance of StimRouter, surgical outcomes, health-related quality of life, concomitant medical use, and subject's impression of improvement.
International CIPN Assessment and Validation Study
Chemotherapy-induced Peripheral NeuropathyQuality of LifeThis is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.
Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative...
PainPain Syndrome11 moreOver the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic pain disorders due to traumatic or post-operative peripheral neuropathy. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to traumatic or post-operative peripheral neuropathy.
Methadone to Treat Painful Chemotherapy-induced Peripheral Neuropathy
Chemotherapy-induced Peripheral NeuropathyChemotherapy induced peripheral neuropathy (CIPN) is a painful and disabling nerve pain that can be caused from common types of chemotherapy used to treat cancer. It can affect up to 70% of people who receive chemotherapy for months or even life-long. CIPN causes "glove-and-stocking" distribution of nerve-pain, weakness, lower quality of life, lower ability to do day to day tasks such as walking and writing, and other symptoms. Duloxetine is the only recommended medication by national and international groups such as the American Society of Oncology to treat painful CIPN. However, studies show it only has small benefit; for example, the largest study showed it only reduces pain by 0.73 out of 10 points compared to placebo. Another promising medication in theory and practice is methadone. It is a very well studied and commonly used pain medication from a class called opioids. However, it does have unique qualities that make it more effective to treat nerve pain when compared to other opioids like morphine and fentanyl. Furthermore, studies show it may develop less tolerance in the body over time when compared to other opioids; this is helpful as many develop lifelong CIPN and therefore may benefit from lifelong pain medication. Methadone has not been studied in CIPN. This study is a pilot clinical trial to assess the ability of methadone to lower the pain caused by CIPN. It will help determine if it is feasible (ie. a good idea) to conduct a much larger study to absolutely determine if methadone is able to treat painful CIPN. In this pilot study, participants will receive methadone three times a day for 5 weeks. They will be followed virtually or in-person weekly for 5 weeks where they will answer brief questionnaires which will help determine the effect of their treatment on their pain and their dose will increase until their pain is hopefully controlled.
Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathic PainDiabetic Peripheral Neuropathy (DPN) is one of the most common chronic complications of diabetes mellitus, which mainly manifests symmetric pain, numbness, ankylosis, or with abdominal distension, abnormal sweating, and accompanied by glove-sock-like hyperalgesia or loss of sensation as the main symptom, which seriously affects the quality of life of patients. Although drug treatment has some effect, from the overall long-term perspective, long-term medication is easy to produce drug dependence, and often easy to cause ataxia, blurred vision, constipation, diplopia, nausea and other adverse drug reactions. Electroacupuncture treatment for DPN has certain advantages, with clear efficacy and no toxic side effects, and is being increasingly recognised by the public and professionals. The study is designed to observe the therapeutic effect and safety of electroacupuncture (EA) in the treatment of DPN.
Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)
Chemotherapy-induced Peripheral NeuropathyThis is a prospective natural history study of CIPN in approximately 200 participants receiving taxanes (paclitaxel, docetaxel) for breast cancer, bortezomib for multiple myeloma, oxaliplatin-based regimens for colorectal cancer, or vincristine for lymphoma.. Demographic data, medical history, electronic PROs, ClinROs blood biomarkers including NF-L, PGx DNA analyses and Bedside-QST will be assessed at Baseline. The Observation Period will initiate with the first dose of chemotherapy and conclude with the last dose of chemotherapy. During the Observation Period, participants will be evaluated for the development of CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will be measured at various timepoints corresponding with treatment regimen schedules throughout the observation period. The Post Chemotherapy Follow-up Period will begin with the first visit after the last dose of chemotherapy and conclude 6 months after the last dose of chemotherapy. During the Post Chemotherapy Follow-up Period, participants will be evaluated for CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will also be measured at the beginning and at the end of the Post-Chemotherapy Follow-up Period. PROs will be assessed electronically on a monthly basis.
Muscle Structure, Function and Gait in dHMN
Distal Hereditary Motor NeuropathyType II4 moreDistal Hereditary Motor Neuropathy (dHMN) is a rare inherited neuromuscular disorder. It is characterised by distal weakness. The condition usually manifests in the second decade of life and progresses slowly. Though patients usually have a normal lifespan it is a disabling condition and most eventually need aids to walk. In order to improve walking quality in patient with dHMN, research is needed to understand the impairments that lead to altered gait patterns, and to develop interventions to correct walking gait conservatively. In this proposed trial our goal is to explore the relationships between muscle structure, function and gait patterns for people with Distal Hereditary Motor Neuropathy. Over 12 months, muscle changes in dHMN are going to be observed in terms of structure and function using MRI, myometry and 3D motion analysis. In addition, the effect of a 16 weeks exercises program on muscle structure and function in dHMN is going to be measured by the same observational methods. To address walking gait directly in dHMN, gait patterns with and without wearing carbon fibre ankle foot orthoses (AFO)will be measured using 3D motion analysis.