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.
Stibium Metallicum Praeparatum 6x Versus Placebo in the Prevention of Paclitaxel-induced Peripheral...
Chemotherapy Induced Peripheral Neuropathy (CIPN)Chemotherapy induced peripheral neuropathy (CIPN) is one of the most limiting side effects of chemotherapy and often leads to adaptations in the protocol of the chemotherapy including dose reduction or even discontinuation of treatment. In general, the symptoms of CIPN are sensory, often distributed in a "stocking and glove" manner, and include pain, tingling, and numbness. CIPN has a marked negative influence on quality of life of patients and their families. It may result in serious limitations in daily functioning and affect the enjoyment, social relationships, and ability to perform work. Current management of CIPN (i.e. prevention and treatment) includes dose reduction or delay of chemotherapy cycles and treatment discontinuation. Unfortunately, this reduces the chance of an effective cancer treatment. Current guidelines of the American Society of Clinical Oncology (ASCO) on the Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy do not conclusively recommend any agent for the prevention of CIPN. Due to the scarcity of drugs that are effective for preventing and treating CIPN, the distress of patients who suffer from CIPN, and the major societal and economic costs, new approaches and effective treatment strategies are required. The proposed trial is a parallel, double blind, placebo controlled, randomised, phase III superiority trial, aiming to determine whether treatment with SMP prevents incidence of or reduces the severity symptoms of paclitaxel-induced peripheral neuropathy, as compared to placebo.
The Role of TRP Channels in CIPN
Chemotherapy-induced Peripheral NeuropathyPart I: Evaluating the increase in dermal blood flow upon topical application of cinnamaldehyde and capsaicin on the fingers in healthy, male volunteers. In addition, the inter-period and inter-hand reproducibility of the increase in dermal blood flow will be assessed. Part II: Evaluating the increase in dermal blood flow upon topical application of cinnamaldehyde and capsaicin on the fingers in patients suffering from chemotherapy-induced peripheral neuropathy compared to matched healthy volunteers. Part III: Evaluating the increase in dermal blood flow upon topical application of cinnamaldehyde and capsaicin on the fingers in patients who are treated with paclitaxel or oxaliplatin.