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

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.

Eligibility

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.

Conditions4

Interventions1

Locations1 site

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