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

NCT07260656 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IRB-25-2072
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

diabetic foot pain

Outcome Measures

Primary Outcomes (1)

• Significant reduction in foot pain in participants with chronic diabetic neuropathic foot pain.

  Participants will complete a Numeric Rating Scale (NRS) twice a day for 14 days one hour after applying topical cream to the area of their foot where they are experiencing Diabetic Peripheral Neuropathy foot pain. Participants will not be aware of whether the topical cream applied includes capsaicin palmitate. The NRS rates the intensity of symptoms with a scale of 0 to 10 with 0 being no symptom present to 10 being the worst possible intensity. The symptoms being assessed include redness, irritation, itching, tingling, and a burning or cooling sensation one hour after applying the topical cream. Study investigators will review the variances in the NRS ratings throughout the duration of the 14 days of all participants and report any changes from baseline scores. Data will be analyzed using one-way repeated measures ANOVA, followed by the Mann-Whitney U post-hoc test. Data will be visualized as box-and-whisker plots, comparing Capsadyn to placebo.

  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

Study Arms (2)

Capsadyn Arm

ACTIVE COMPARATOR

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

Drug: Capsaicin Palmitate

Placebo Arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Capsaicin Palmitate DRUG

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.

Also known as: Capsadyn

Capsadyn Arm

Placebo DRUG

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.

Also known as: OTC topical cream

Placebo Arm

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24016, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetic Foot

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert Carpenter, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Autumn Weidman

CONTACT

(540) 240-1695; alweidman@carilionclinic.org

Adam Cordell

CONTACT

(540) 566-8542; ajcordell@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Pharmacist will randomize participants 1:1 between the two arms, either Capsadyn or placebo. Study products will provide blinded product to study staff to provide to participants in coded, white-labeled, one ounce plastic jars.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participant population will be scheduled for an even split between the two study arms.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 3, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)