Actively Recruiting

Early Phase 1
Age: 25Years - 75Years
All Genders
NCT07260656

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

Led by Carilion Clinic · Updated on 2026-04-20

80

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 25Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 3 toes per foot
  • Feet must be otherwise intact
  • No eczema, hyperkeratosis, scleroderma, or other skin conditions affecting the area of cream application
  • Agree to apply the cream to painful areas of feet as directed
  • Agree to apply the cream twice daily
  • Willing to wait 60 minutes after application before filling out pain rating forms
  • Willing to wait at least 60 minutes before washing feet after application unless burning occurs
  • Willing to use cream in a blinded manner
Not Eligible

You will not qualify if you...

  • Younger than 25 or older than 75 years
  • Any skin condition that may disrupt skin integrity or alter sensation in the feet
  • Any open wounds, skin ulcers, infections, irritation, eczema, trauma, or burns on feet within 30 days
  • Recent foot surgery
  • Use of any topical foot medications or creams (including holistic, cannabinoid, prescription, or OTC) unless stable prior to study
  • Current substance abuse
  • Allergy or hypersensitivity to chili peppers, coconut oil, Shea butter, or sunflower seed oil
  • Use of concurrent foot pain therapies that might interfere with pain assessments (except physical therapy or exercise)
  • Participation in another clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Carilion Clinic

Roanoke, Virginia, United States, 24016

Actively Recruiting

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Research Team

A

Autumn Weidman

CONTACT

A

Adam Cordell

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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