Topical Capsadyn (palmitated capsaicin) for diabetic neuropathic foot pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This double-blind, randomized, placebo-controlled early phase 1 trial compares a palmitated capsaicin topical cream (Capsadyn) to a matched carrier placebo with participants randomized 1:1. Up to 40 adults with diabetic peripheral neuropathy and intact feet will apply the assigned cream to painful foot areas twice daily and complete timed pain ratings while continuing stable pre-study medications as allowed. Test articles are packaged in coded jars and dispensed by the pharmacy to keep both participants and clinicians blinded, and dosing may be applied unilaterally or bilaterally over the complete painful area. An interim look will be performed after enrollment to monitor compliance and study progress.

Why it matters

Who can join: the full rules

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.

Where it's running

• Carilion Clinic
  Roanoke, Virginia, United States Recruiting

Study contacts

• Principal investigator: Robert Carpenter, MD — Carilion Clinic
• Study coordinator: Autumn Weidman
• Email: alweidman@carilionclinic.org
• Phone: (540) 240-1695

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.