A Double-Blind, Randomized, Pilot Study to Investigate the Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn4) In the Treatment of Diabetic Neuropathic Foot Pain

What this Trial Is About

Researchers are evaluating whether a topical cream containing capsaicin palmitate can reduce foot pain in people diagnosed with Diabetic Peripheral Neuropathy (DPN). This double-blind, randomized, placebo-controlled trial aims to compare the pain relief effects of the active cream versus a placebo cream, while monitoring any side effects or discomfort from use. The study is sponsored by Carilion Clinic and focuses on adults aged 25 to 75 years with painful diabetic neuropathy affecting their feet. Participants are randomly assigned to one of two groups: one receiving a topical cream with 0.25% capsaicin palmitate, and the other receiving a placebo cream without the active ingredient. Both creams are applied twice daily, once in the morning and once in the evening, to the entire painful area on one or both feet. The study uses coded jars to ensure neither the participant nor the clinician knows which cream is being used. The study plans to enroll 40 participants with an interim review to assess progress and compliance. During the 14 days after each cream application, participants record their foot pain twice daily using a Numerical Rating Scale (NRS) to measure pain reduction. Researchers will monitor participant adherence to the application instructions, including waiting times before completing pain assessments and washing feet. The study also includes standard care visits and restrictions on other pain treatments to ensure accurate assessment of the topical cream's effects. Participation will last through the treatment and monitoring periods as outlined in the study schedule.

Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain