Active clinical trials for "Diabetic Neuropathies"

This study relies on the use of a smartphone application (SOMA) that the investigators developed for tracking daily mood, pain, and activity status in acute pain, chronic pain, and healthy controls over four months.The primary goal of the study is to use fluctuations in daily self-reported symptoms to identify computational predictors of acute-chronic pain transition, pain recovery, and/or chronic pain maintenance or flareups. The general study will include anyone with current acute or chronic pain, while a smaller sub-study will use a subset of patients from the chronic pain group who have been diagnosed with chronic low back pain, failed back surgery syndrome, or fibromyalgia. These sub-study participants will first take part in one in-person EEG testing session while completing simple interoception and reinforcement learning tasks and then begin daily use of the SOMA app. Electrophysiologic and behavioral data from the EEG testing session will be used to determine predictors of treatment response in the sub-study.

Diabetic neuropathies are the most prevalent chronic complications of diabetes mellitus. The early recognition and appropriate management of neuropathy in the patient with diabetes is important for patient's quality of life and life expectancy. Ozone is well known to have anti-inflammatory and analgesic effects through the inhibition of pro-inflammatory mediators; as well as. stimulation of anti-inflammatory mediators' release

One in five foot ulcers are caused by the footwear worn by people with diabetes, yet there is a lack of consensus around footwear fit. Recommended toe gaps (the gap between the longest toe and the inside of the shoe) vary depending on the footwear guidance referred to but no research to date has assessed the recommendations' effectiveness in minimising in-shoe pressures. The investigators will carry out a pilot study in 60 people with diabetes and loss of foot sensation (neuropathy). In this study, the investigators will measure in-shoe pressures whilst participants walk at the same pace to the beat of a metronome. An insole placed inside participants' shoes will measure in-shoe pressures. Participants will wear the same (standardised) type of footwear. The study is designed to detect a difference in pressure within this made-to-measure footwear whose fit conforms to Standard 1 guidance compared with footwear whose fit conforms to Standard 2 guidance. Differences between Standards 1 and 2 with Standard 3 will be considered secondary analyses. Standards are simplified to three non-overlapping recommended toe gap ranges of 0.5-1.0cm; 1.5-2.0cm and 1.0-1.5cm. The investigators will also analyse the heat images taken with a thermographic camera before and after walking in standardised footwear whose fit confirms to these standards (this is known as the plantar thermal stress response to walking). Footwear fit will be determined by measuring the dimensions of participants' feet and that of participants' footwear and comparing the two. The investigators will also measure footwear fit and associated in-shoe pressure/plantar thermal stress response in participants' habitual footwear during walking at paced and self-selected speeds.

Over 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 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.

Over 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.

Diabetic 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.

A complication of diabetes mellitus is damage to nerves called neuropathy. There are several mechanisms involved that will lead to the development of neuropathy. Neuropathy can lead to foot ulcers, infections and amputations. Patients with neuropathy may also experience pain, which can be difficult to control and the medications are limited by side effects. Despite this there are no approved treatments to reverse the progression of neuropathy and the management of patients is focused on controlling blood glucose and other metabolic factors to prevent neuropathy and its symptoms from getting worse. Patients with type 1 diabetes are prescribed multiple daily injections (MDI) of insulin to manage their glucose control. However, insulin pump therapy and, more recently, automated insulin delivery (AID) or the Artificial Pancreas can be used as the insulin delivery method for patients with type 1 diabetes mellitus. Manchester Diabetes Centre is the first adult diabetes centre in Europe to pioneer and use a commercially-approved AID in clinical practice. Insulin pump therapy and AID have the advantage of being able to provide insulin at variable doses, which is closer to the natural process occurring within an individual without diabetes. Both are currently considered to be the most physiological method of insulin delivery and have been shown to improve glycaemic control, quality of life (QOL) and reduce the risk of hypoglycaemia (low blood glucose level). The investigators have previously shown in a small group of people that use of an insulin pump therapy may improve symptoms of painful neuropathy via a more stable glucose profile. The peaks and drops in insulin may make neuropathy worse. In this study the investigators aim to investigate the use of insulin pump therapy and AID in their effect on neuropathy. This will be in comparison to a control group of patients on MDI. The investigatorsbwill use a variety of neuropathy measures and symptom questionnaires to assess structural and functional neuropathy status. The investigators hypothesise that those patients receiving the newer technologies will demonstrate an improvement in symptoms and nerve regeneration. This finding would have a significant impact for patients as it would provide evidence to suggest that those patients with neuropathy should be put onto an insulin pump or AID to improve neuropathy and its symptoms. As these are treatments that are already available on the NHS to patients satisfying specific criteria this study aims to show benefit in this cohort of patients which can be implemented immediately in clinical practice.

Painful diabetic neuropathy (pDN) occurs in a subset of diabetic patients, and is characterize by burning, shooting, and electric shock-like pain in the arms and legs. This represents a major health crisis, given the increasing prevalence of pDN and the significant impact it has on quality of life. However, there is limited evidence of effective therapies for pDN pain relief. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive form of brain stimulation that may be a promising therapy for pDN. Previous research has shown that rTMS reduces neuropathic pain in pDN (1, 2, 3). While this is promising, it is important to note that rTMS is effective for ~50% of patients with neuropathic pain. (4, 5). Recent advancements in rTMS technology have created the opportunity for remarkable strides in the effectiveness of this potential therapy. This new development called controlled pulse parameter TMS (cTMS) increases the magnitude and longevity of TMS-induced effects. Although not tested in chronic pain, cTMS possess the power to make transformative changes in pDN, potentially yielding greater and widespread improvements in pain. The overarching goal of the proposed research is to assess the effects of a 5-day cTMS stimulation protocol on measures of pain and neurological function in individuals with pDN. Kwak S, Choi SG, Chang GS, & Yang MC (2022). Short-term Effect of Repetitive Transcranial Magnetic Stimulation on Diabetic Peripheral Neuropathic Pain. Pain Physician, 25(2), E203-E209. Abdelkader AA, Gohary AME, Mourad HS, & Salmawy DAE (2019). Repetitive tms in treatment of resistant diabetic neuropathic pain. Egyptian Journal of Neurology, Psychiatry and Neurosurgery, 55(1). Onesti E et al. (2013). H-coil repetitive transcranial magnetic stimulation for pain relief in patients with diabetic neuropathy. European Journal of Pain (United Kingdom), 17(9). Attal N et al. (2021). Repetitive transcranial magnetic stimulation for neuropathic pain: a randomized multicentre sham-controlled trial. Brain, 144(11). 65. Dongyang L et al. (2021). Posterior-superior insular deep transcranial magnetic stimulation alleviates peripheral neuropathic pain - A pilot double-blind, randomized cross-over study. Neurophysiologie Clinique, 51(4).

This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on diabetes peripheral neuropathy.

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.