NCT07260656

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

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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Carilion Clinic · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a double-blind, randomized, placebo-controlled trial with two arms to assess the pain-reducing effects of topical Capsadyn compared to a placebo (carrier cream). At the appointment/recruitment visit, patients will receive standard of care as determined by their clinician. At the first visit, participants opting into the trial will not receive any new medications designed for producing pain relief alongside the Test Article but will continue medications taken before entry to the study, if use history is stable, or medications not specifically designed for pain reduction. Both the clinician administering the Test Article and the participant will be blinded to Test Article, or unaware of whether it is Capsadyn or placebo. A Test article can be administered to either a unilateral area, or bilateral painful areas. Test Article should be administered over the complete painful area. Test Articles will be packaged in coded, white-labeled one-ounce plastic jars, marked only with a code indicating Capsadyn or placebo, and sent to Carilion Pharmacy for distribution to healthcare providers. The pharmacy will quarantine the Test Articles and randomize Test Article scheduling between the two arms. The participant population will be scheduled for an even split between the two study arms. With the recruitment of 40 participants (20 per group), an interim look at the data will be done to assess participant compliance with instructions, general progress of the study and to troubleshoot any issues that may have arisen.

Conditions

• Diabetic Neuropathies, Painful
• Diabetic Foot
• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2025-12-03
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study