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NCT07260656

EARLY_PHASE1

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

Sponsor: Carilion Clinic

View on ClinicalTrials.gov

Summary

The purpose of this research is to assess whether the use of a topical cream with an active ingredient can reduce the amount of foot pain experienced in participants who have been diagnosed with Diabetic Peripheral Neuropathy (DPN) with minimal side effects or discomfort from use.

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

Key Details

Gender

All

Age Range

25 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12

Completion Date

2027-11

Last Updated

2025-12-03

Healthy Volunteers

Conditions

Diabetic Neuropathies, Painful Diabetic Foot Diabetic Peripheral Neuropathy

Interventions

DRUG

Capsaicin Palmitate

Participant will apply a small amount of topical cream (size of a quarter) to one or both feet twice a day, once in the morning and once in the evening.

DRUG

Placebo

Participant will apply a small amount of topical cream (size of a quarter) to one or both feet twice a day, once in the morning and once in the evening.

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.

Locations (1)

Carilion Clinic

Roanoke, Virginia, United States