Active clinical trials for "Diabetic Neuropathies"

Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain

This study is a randomized, parallel, open-label, multicenter, phase IV clinical trial to assess the efficacy and safety of pregabalin and alpha-lipoic acid combination compared with each monotherapy in patients with diabetic peripheral neuropathy for 12 weeks.

Investigate the efficacy and safety of HSK16149 capsules in Chinese diabetic peripheral neuropathic pain (DPNP) following 13 weeks treatment in comparison to placebo.

Neuropathic pain occurs as a result of damage or disease of the peripheral or central nervous system. Regardless of its cause, neuropathic pain (NeP) leads to a characteristic clinical picture characterized by ongoing pain with steady or dysesthetic pain, such as burning or aching, and paroxysmal pain such as shooting or stabbing. In conditions such as diabetic neuropathy, changes in the membrane-bound proteins that form ion channels may alter the electrical properties of the injured neuron, called remodeling. The net effect of membrane remodeling is greater excitability of neurons, leading to a tendency towards action potential generation and propagation in injured primary sensory neurons which occurs in the context of nerve injury and disease. Over the past decade, a new endogenous cannabinoid receptor-mediated system within the nervous system and upon immune-mediated cells has been described. The cannabinoid receptor system consists of two receptors, CB1 and CB2 receptors, as well as endogenously produced endocannabinoids which agonize these receptors. This is a multicenter trial amongst Western Canadian sites to compare the efficacy of nabilone versus placebo in treating patients with chronic neuropathic pain (NeP) due to diabetic peripheral neuropathy (DPN). A one-week screening period will occur, during which pain scores and sleep scores will be tabulated. Following screening, a 4-week period of single blind treatment with flexible dosing of nabilone at 0.5 - 4 mg/day will initiate. All subjects will begin with nabilone therapy of 1 mg daily for a minimum of 4 days, with the dose of the study medication assessed and adjusted either upwards or downwards as needed to balance efficacy for pain control with tolerability of possible side effects. All subjects who experience at least a 30% reduction in their weekly mean pain score during the single blind flexible dosing phase will be considered a responder, and will be further continued in the study. During the double-blind portion of the study, subjects randomized to nabilone will continue on the dose of nabilone achieved at the completion of the single-blind phase, and this dose will be maintained throughout the double-blind phase. Subjects randomized to placebo will receive 1 mg of nabilone daily for one week, followed by 4 consecutive weeks of placebo. This dose of nabilone will permit a tapering for those subjects achieving a higher daily dose of nabilone during the single-blind phase, or will maintain those who were taking only 1 mg per day in the single-blind phase, preventing an abrupt termination of treatment in subjects who are randomized into the placebo portion of the study.

Rationale: Diabetic neuropathy is one of the most common complications of Diabetes Mellitus (DM). Pain is a common symptom of diabetic neuropathy, affecting 11-34% of patients suffering form DM. The burden of disease of painful diabetic polyneuropathy (PDP) is high for both the patient and society, due to significant pain levels, frequent co-morbidity, polypharmacy and significant health resource use. Spinal cord stimulation (SCS) has been used for over 30 years to treat neuropathic pain. Several small clinical studies have shown a beneficial effect of SCS on pain in PDP. Objective: The primary objective of this study is to investigate whether SCS leads to clinically relevant (≥50%) pain relief in patients with moderate-to-severe PDP in the lower limbs after 6 months of treatment. Secondary objectives to investigate 1) the effect of SCS on health related quality of life in PDP; 2) the effect of SCS on the quality of sleep in PDP; 3) the effect of SCS on mood in PDP; 4) the effect of SCS on blood glucose control in PDP; 5) the effect of SCS on large and small nerve fibre functions in PDP; 6) identifying predictive factors for success of SCS treatment of PDP; after 6 months 7) the effect of SCS on small fibre loss and regeneration in PDP; and 8) costs, cost-utility and cost-effectiveness after 12 months of treatment. Study design: the study is a multi centre randomized controlled trial. Study population: Patients suffering from moderate-to-severe PDP in the lower limbs due to diabetes mellitus type 1 or type 2 as diagnosed by clinical symptoms (glove and stocking distribution). Intervention: patients assigned to group 1 will receive spinal cord stimulation (SCS) and/or best (drug) treatment as possible, patients assigned to group 2 will receive best (drug) treatment as possible. Main study parameters/endpoints: The main study parameter will be the mean pain intensity and/or maximal pain intensity during daytime and/or during night time as measured on a weighted NRS and/or a PGIC for pain and sleep measured on a 7-point Likert scale, after 6 months of treatment. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: SCS related risks include: lead migration (14%), lead breakage (7%), implanted pulse generator migration (1%), loss of therapeutic effect, lost or unpleasant paresthesias (12%), infection or wound breakdown (10%), Pain at IPG incision site (12%), IPG pocket fluid collection (5%). Treatment-as-usual related risks are related to the medication used and do not increase due to participation in this study.

This study describes a controlled randomized clinical trial to evaluate the effect of inspiratory muscle training in patients with diabetic autonomic neuropathy.

The investigators conducted a randomized, Double blind, and Controlled Study to evaluate the Efficacy and safety of Lidocaine Infusion Treatment in Management of Neuropathic pain.

A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi Deficiency and Blood Stasis)

This prospective study was was divided into 2 parts and carried out at 2 sites in Germany. Part 1 assessed Repeatability in healthy, non-diabetic population (Group "control"). Part 2 collected data to evaluate the diagnostic and prognostic value of using Heidelberg Engineering Retina Tomograph (HRT) 3 with the Rostock Cornea Module EyeGuidance functional module (HRT RCM-E) in subjects with early to moderate DPN (Groups"none" and "mild", respectively).

The proposed study will randomize participants with diabetic peripheral neuropathy into two groups. One group of participants will receive standard-of-care counseling while the other group will undergo supervised exercise and counseling to increase physical activity.