Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age25-75
SponsorCarilion Clinic
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Capsaicin Palmitate
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov