Recruiting
Early Phase 1

Topical Cream

Sponsor:

Carilion Clinic

Code:

NCT07260656

Conditions

Diabetic Neuropathies, Painful

Diabetic Foot

Diabetic Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Capsaicin Palmitate

Placebo

Study Details

Brief 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.

Conditions

Diabetic Neuropathies, Painful

Diabetic Foot

Diabetic Peripheral Neuropathy

Study ID

NCT07260656

Start date

Nov 26, 2025

Status verified date

Apr, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Capsadyn Arm

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

placebo comparator: Placebo Arm

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

Interventions

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.

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.

Primary outcome measure

  • Significant reduction in foot pain in participants with chronic diabetic neuropathic foot pain. [ Time Frame: A NRS will be completed by the participant twice a day, once in the morning and once in the evening, for 14 days after each application of the topical cream provided ]

Central Contacts and Locations

Central contacts

Autumn Weidman

(540) 240-1695alweidman@carilionclinic.org

Adam Cordell

(540) 566-8542ajcordell@carilionclinic.org

Locations

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

Internal Medicine

540-224-5170

Principal Investigator:

Robert Carpenter, MD

More Information

Sponsor

Carilion Clinic

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • diabetic foot pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2026-04-20.