Topical Pirenzepine for Diabetic Neuropathy

This trial explores whether a new topical treatment, pirenzepine (a medication applied to the skin), can alleviate painful peripheral neuropathy in individuals with Type 2 Diabetes. Participants will apply either the active treatment or a placebo (a solution without the active ingredient) to their calves, ankles, and feet daily for 12 weeks. The trial aims to determine if the treatment can reduce pain and discomfort. Individuals who have experienced painful peripheral neuropathy in their lower legs for at least a year and have stable diabetes and pain management plans might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

The trial does not specify if you need to stop your current medications. However, you must be on stable diabetic and pain treatments before and during the study, and certain topical pain treatments are not allowed.

Research has shown that topical pirenzepine is generally well-tolerated. In past studies, researchers carefully monitored participants' heart rate and blood pressure to ensure safety. The results revealed no major changes or serious safety issues, suggesting the treatment is safe for most people. However, like any medication, some might experience minor side effects. Always consult a healthcare provider to make the best choice for your health.¹²³⁴⁵

Unlike the standard treatments for painful peripheral neuropathy in type 2 diabetes, which often include oral medications like gabapentin or duloxetine, pirenzepine offers a unique approach as a topical solution. This treatment is exciting because it targets the affected areas directly, potentially reducing systemic side effects common with oral medications. Additionally, pirenzepine's mechanism involves modulating the muscarinic receptors, offering a new pathway to manage nerve pain as opposed to the traditional methods that often focus on neurotransmitter modulation. Researchers are hopeful that this targeted, topical approach will provide more effective and safer pain relief for patients.

Research has shown that pirenzepine might alleviate painful nerve damage in people with diabetes. Studies have found that applying pirenzepine to the skin can promote nerve growth and protect against damage. In several animal studies, blocking certain nerve effects with pirenzepine led to nerve protection and growth. Early results also suggest that this treatment can reduce pain from nerve damage. Over time, applying pirenzepine to the skin has shown promise in helping nerves damaged by neuropathy to regrow. Participants in this trial will receive either the WST-057 active topical solution containing pirenzepine or a placebo solution, both applied once daily for 12 weeks.¹⁶⁷⁸⁹