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Diabetic Neuropathies clinical trials

View clinical trials related to Diabetic Neuropathies.

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NCT ID: NCT06025422 Recruiting - Diabetic Foot Ulcer Clinical Trials

In-shoe Pressures Associated With Footwear Fit Guidelines

Start date: March 13, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT05985291 Recruiting - Clinical trials for Painful Diabetic Neuropathy

BurstDR Stimulation for Painful Diabetic Neuropathy

Start date: July 3, 2023
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT05965336 Recruiting - Clinical trials for Diabetic Peripheral Neuropathy

Walking Function in Diabetic Peripheral Neuropathy

Start date: May 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to 1) examine the differences in walking function and movement patterns between individuals with diabetic peripheral neuropathy and healthy adults with no known conditions; 2) examine if receiving feedback on walking form will help change walking patterns; and 3) examine the feasibility, safety, and preliminary effects of walking training with feedback on walking function in individuals with diabetic peripheral neuropathy.

NCT ID: NCT05937152 Recruiting - Clinical trials for Diabetic Polyneuropathy

A Study of CGRP Monoclonal Antibody to Treat Diabetic Neuropathy

Start date: June 2024
Phase: Phase 2
Study type: Interventional

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).

NCT ID: NCT05906199 Recruiting - Clinical trials for Diabetic Peripheral Angiopathy

A Study to Compare the Effects of Improving the Carotid Artery Intima Media Thickness and Changing Lipid Levels by Cilostazol/Ginkgo Leaf Extract and Aspirin in Diabetic Peripheral Angiopathy.

Start date: July 28, 2021
Phase: Phase 4
Study type: Interventional

This study is to compare and evaluate the effect of improving the carotid IMT and lipid level of the Cilostazol/Ginkgo leaf extract group with the aspirin administrated group in patients with diabetic peripheral angiopathy.

NCT ID: NCT05895552 Recruiting - Clinical trials for Diabetic Peripheral Neuropathic Pain

A Phase 2 Study of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (CYPRESS)

CYPRESS
Start date: August 21, 2023
Phase: Phase 2
Study type: Interventional

This is a 2-part, randomized, placebo-controlled, double-blind, Phase 2 study to evaluate the safety, tolerability, efficacy, and PK of RTA 901 in qualified subjects with DPNP. Each study part will be randomized into 3 treatment arms; 2 different doses of RTA 901 and a Placebo. The doses of RTA 901 in Part 2 will be selected based on the Exposure-Response (E-R) analyses of data from Part 1. A total of 384 subjects will be randomized in this study. Each part will have 192 subjects, with 64 subjects randomized 1:1:1 to each treatment arm. The duration of each part of the study will be approximately 20 weeks, including a Screening Period of up to 2 weeks, a Run-in Period of 2 weeks, a Treatment Period of 12 weeks, and a Follow-up Period of 4 weeks. All subjects in Part 1 and Part 2 of the study will follow the same visit and assessment schedule. Eligibility will be assessed during the Screening and Run-in Periods.

NCT ID: NCT05863793 Recruiting - Clinical trials for Diabetic Peripheral Neuropathy

Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes mellitus that has a considerable impact on quality of life, but there are few effective therapeutic strategies. The aim of this trial is to determine the efficacy and safety of manual acupuncture (MA) versus sham acupuncture (SA) for DPN.

NCT ID: NCT05838755 Recruiting - Pain Clinical Trials

A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain

NEPTUNE-17
Start date: September 20, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.

NCT ID: NCT05813496 Recruiting - Clinical trials for Polyneuropathy, Diabetic

Phase IV Trial to Evaluate Efficacy of Alpha-Lipoic Acid in Treating Symptomatic Diabetic Polyneuropathy in Egypt

MIRACLE-ALA
Start date: October 26, 2022
Phase: Phase 4
Study type: Interventional

The purpose of the study is to find out whether ALA is effective and safe for treating Egyptian diabetic patients with symptomatic polyneuropathy. The ADA stated that despite the exploration of several pharmacological therapies for DPN management, substantial evidence on medicines that modify the natural history of DPN is still absent. This is a multicenter, interventional, two-arm, parallel-group, randomized, double-blinded, placebo-controlled, phase IV trial. Patients will be administered either one tablet of placebo or one tablet containing 600 mg of ALA twice a day for 24 weeks, depending on the randomization process.

NCT ID: NCT05777317 Recruiting - Clinical trials for Painful Diabetic Neuropathy

Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy

PDN-SENSORY
Start date: April 24, 2023
Phase: N/A
Study type: Interventional

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.