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

Part of paid clinical trials in Roanoke, Virginia.

Sponsor
Carilion Clinic
Study ID
NCT07260656
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 26, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Capsadyn Arm
    participant will receive an over-the-counter topical cream with .25% capsaicin palmitate
  • Placebo Comparator: Placebo Arm
    participant will receive an over-the counter topical cream with no active ingredient

Primary Outcome Measure

Significant reduction in foot pain in participants with chronic diabetic neuropathic foot pain. [ 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 provided ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Carilion ClinicRoanokeVirginia24016
Internal Medicine
540-224-5170
Robert Carpenter, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Carilion Clinic· Roanoke, VA

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