Topical Capsaicin for Diabetic Neuropathic Foot Pain Relief
This study aims to evaluate if a topical cream containing capsaicin can significantly reduce foot pain in people with chronic diabetic neuropathic foot pain.
Capsaicin Palmitate
+ Placebo
Cardiovascular Diseases+13
+ Diabetes Mellitus
+ Diabetic Angiopathies
Treatment Study
Summary
Study start date: December 1, 2025
Actual date on which the first participant was enrolled.This study focuses on finding out if a special cream called Capsadyn® can help reduce foot pain caused by diabetic neuropathy. Diabetic neuropathy is a common condition where people with diabetes experience pain and discomfort in their feet due to nerve damage. The goal is to see if Capsadyn, when applied to the skin, can alleviate this pain better than a cream that doesn't contain the active ingredient. This research is important because it could lead to a new way to manage foot pain for people with diabetes, improving their quality of life. Participants in the study will apply either the Capsadyn cream or a placebo cream to their painful foot areas. The creams will be packaged in identical containers, so neither the participants nor the administrators know which cream is being used. Participants are asked to continue any existing medications they are taking but will not start any new pain relief medications during the study. They'll rate their pain twice a day using a scale from 0 to 10, where 0 means no pain and 10 means the worst pain possible. This will help researchers determine if there's a significant reduction in pain when using Capsadyn compared to the placebo. The data collected will be carefully analyzed to see if Capsadyn is effective in reducing foot pain.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 25 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * At least 3 toes per foot * Have otherwise intact feet. * Absence of any eczema, hyperkeratosis, scleroderma, or other dermatological conditions afflicting the area of Test Article administration that may interfere with absorption, particularly hyperhidrosis. * Must agree to apply the Test Article to painful areas of feet as directed by research personnel. * Must agree to apply the Test Article to feet as instructed 2x per day. * Must wait 60 minutes after each application of Test Article before filling out NRS forms. * Unless burning is encountered soon after application, the participant must wait at least 60 minutes before washing feet after application of Test Article. * All participants must be willing to use Test Articles blinded. Exclusion Criteria: * Younger than 25 and older than 75 years of age * Any dermatological condition(s) with the potential to disrupt skin integrity or alter sensory function of the feet. * Any open wounds, skin ulceration, infection, skin irritation (e.g., poison oak), history of eczema, trauma or burn (including sunburn) affecting the feet within 30 days. * Any recent medical history of surgery affecting the feet. * Unless part of a stable continuum of substance use prior to start of study, the use of any topical medication products on feet, including holistic formulations, patch or herbal products, cannabinoid products, prescription or over the-counter (OTC) analgesic creams/lotions/patches/gels, nonsteroidal anti-inflammatory drugs, acetaminophen, counterirritants, local anesthetics, or steroids is prohibited. * Current substance abuse. * History of hypersensitivity or allergy to chili peppers, coconut oil, Shea butter, or sunflower seed oil. * Except for interventions for mobility, (e.g., physical therapy, exercise, grounding) no concurrent foot therapy for pain that may interfere with NRS evaluations is permitted (e.g., massage, electrophoresis, red light, etc.). * No concurrent enrollment in another clinical trial.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location