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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Capsaicin Palmitate
DrugParticipant 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
DrugParticipant 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Capsadyn ArmActive comparator 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention
Trial outcomes
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.
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 providedSponsors and contacts
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Source ClinicalTrials.gov