Early access
Sign in
Taking people in United StatesEarly phase 1

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

Key facts

Who runs it
Carilion Clinic
Where
Roanoke, United StatesSee the site
Trial code
Status
Recruiting
Phase
Early phase 1
People taking part
80 people, planned
Started
26 Nov 2025
Expected to end
Nov 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Capsaicin Palmitate
  • Placebo
Record updated
20 April 2026

Who can take part

Age
25 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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
  • History of hypersensitivity or allergy to chili peppers, coconut oil, Shea butter, or sunflower seed oil
  • Younger than 25 and older than 75 years of age
  • Current substance abuse

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 25 and 75 years old?

Where in United States

  • Carilion ClinicRoanoke, United StatesContact: Internal MedicineTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Capsadyn ArmExisting treatment, for comparison

    participant will receive an over-the-counter topical cream with .25% capsaicin palmitate

    Treatment: Capsaicin Palmitate

  • Placebo ArmPlacebo, for comparison

    participant will receive an over-the counter topical cream with no active ingredient

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Fit questions
Built from NCT07260656, who can take part
Record updated
20 April 2026