Interventional Clinical Trials on Diabetic Peripheral Neuropathy: A Retrospective Analysis

Abstract

Aims/Introduction Diabetic peripheral neuropathy (DPN) is the most common complication of diabetes. At present, there is no comprehensive summary of the clinical trials related to DPN. In this article, we summarized the basic characteristics of the interventional clinical trials pertaining to DPN to determine the current status of research in this field and the existing issues. Materials and Methods We searched the World Health Organization International Clinical Trial Registration Platform (ICTRP), PubMed and Web of Science for clinical trials from 2005 to April 2021 and extracted 149 registered and 459 published clinical trials on DPN. We summarized the characteristics of the clinical trials, including the source registration, recruitment status, stage, age group, allocation method, intervention, end point classification, funding source, and treatment. Results After excluding noninterventional and nontreatment trials, 149 registered clinical trials out of 292 records from 12 registration centers and 459 published articles were included in this study. Among the registered trials, 43% had been completed, and 34.4% had been published in peer-reviewed journals. Among these trials, more than half used random allocation and blinded placebo-controlled methodologies. A total of 40.3% of the trials were multicenter studies, 63.8% of the treatments were drug therapies, and the endpoint classifications of 49% were efficacy and safety. Of the 459 published interventional clinical trials on DPN, 69.7% of the trials used drug treatments; more than half were randomized, double-blind, placebo-controlled clinical trials; 94.1% had positive outcomes; 46.4% had a target size of 50; and 22.9% were multicenter. Conclusion This paper systematically summarizes the current status of interventional trials on DPN registered in the ICTRP and published clinical trials and provides a reference for the development of high-quality intervention strategies for DPN in the future.

First‐in‐Human Single‐Ascending‐Dose, Multiple‐Dose, and Food Interaction Studies of NRD.E1, an Innovative Nonopioid Therapy for Painful Diabetic Peripheral Neuropathy

“…The most common form of neuropathy is diabetic neuropathy, which develops in approximately half of all patients with diabetes. A common subtype of diabetic neuropathy, accounting for up to 25% of cases, is painful diabetic peripheral neuropathy (PDPN) 2,3 . The symptoms of PDPN interfere with day‐to‐day functioning, quality of life, and sleep and cause anxiety and weakening 4–6 .…”

“…A common subtype of diabetic neuropathy, accounting for up to 25% of cases, is painful diabetic peripheral neuropathy (PDPN). 2,3 The symptoms of PDPN interfere with day-to-day functioning, quality of life, and sleep and cause anxiety and weakening. [4][5][6] The clinical management of patients with PDPN remains a major challenge since most available drugs fail to achieve a relevant pain reduction or are often poorly tolerated.…”

Issues and challenges in diabetic neuropathy management: A narrative review

“…, numbness and dysaesthesia). Painless DN is a result of the predominant loss of small and large nerve fibres[ 6 ] starting at the distal nerve of the limbs before it progresses to the proximal ends in a “glove and stocking” distribution[ 7 ]. Despite massive research aimed at identifying the key culprits of DN, its underlying mechanisms remain complicated and unclear[ 8 , 9 ].…”

Association of Non-Dipping Blood Pressure Patterns with Diabetic Peripheral Neuropathy: A Cross-Sectional Study among a Population with Diabetes in Greece

“…Diabetic peripheral neuropathy (DPN) is the most common neuropathy in developed countries and worldwide [ 1 , 2 ]. According to the International Diabetes Federation (IDF), the prevalence of DPN is expected to rise from 40–60 million people in 2020 to 578 million by 2030 and to 700 million by 2045 [ 3 ]. Up to 50% of populations with diabetes may develop DPN during their lifetime [ 4 , 5 , 6 ], while it is estimated that subjects with type 2 diabetes (T2DM) have a two-fold higher risk compared to type 1 diabetes (T1DM) [ 7 , 8 , 9 ].…”