What this study is
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.
What's being tested
- Capsaicin Palmitate
Intervention · DRUG
- Placebo
Intervention · DRUG
Both interventions
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.
Study details
- 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
- Sponsor
- Carilion Clinic
- Conditions
- Diabetic Neuropathies, Painful · Diabetic Foot · Diabetic Peripheral Neuropathy
- Enrolling
- 80 people
- Starts
- 2025-11-26
- Est. completion
- 2027-11
- Design
- Double-blind, randomized, parallel groups, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 25 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCarilion Clinic
Roanoke, Virginia, United States
- Internal Medicine · Contact540-224-5170
- Robert Carpenter, MD · Principal investigator
Recruiting
Study team
Sponsor
Carilion Clinic
Study ID IRB-25-2072
Principal investigator
Robert Carpenter, MD
Carilion Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.