Capsaicin for Diabetic Neuropathy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a topical cream with an active ingredient called Capsaicin Palmitate, derived from chili peppers, to determine its effectiveness in reducing foot pain in individuals with Diabetic Peripheral Neuropathy (DPN), a condition causing foot pain. Participants will apply the cream to painful areas twice daily. Some will use the active cream, while others will use a placebo cream without an active ingredient. Individuals diagnosed with DPN, having three or more toes per foot, and without skin conditions that could interfere with the cream's absorption, might be suitable for this trial. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this novel treatment.
Will I have to stop taking my current medications?
The trial requires that you stop using any topical medications on your feet, including creams, lotions, or patches, unless they are part of a stable routine before the study starts. Other medications are not mentioned, so it's best to discuss with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that capsaicin, the main ingredient in the treatment under study, is usually well-tolerated. Studies have demonstrated that a capsaicin patch with an 8% concentration, much stronger than the 0.25% used in this trial, has been safely used to treat nerve pain. These studies found that side effects like burning or stinging at the application site are common but generally mild and temporary.
Moreover, the high-strength capsaicin patch has already been approved in Europe and the USA for treating nerve pain, indicating its safety when used under medical supervision. However, since this trial is in its early stages, the researchers are primarily focused on ensuring the safety of capsaicin palmitate at this lower dose and understanding any possible side effects.12345Why do researchers think this study treatment might be promising?
Researchers are excited about Capsaicin Palmitate for diabetic neuropathy because it introduces a new approach to pain relief using a natural compound found in chili peppers. Unlike existing treatments that often focus on oral medications or injections, this treatment is a topical cream, making it easy to apply directly to the area of discomfort. Capsaicin Palmitate works by desensitizing nerve endings and reducing pain signals, offering a potentially fast-acting and targeted relief without the systemic side effects associated with oral medications. This unique mechanism and delivery method could provide a more convenient and effective option for those suffering from diabetic neuropathy.
What evidence suggests that this treatment might be an effective treatment for diabetic neuropathy?
Research shows that capsaicin cream can help reduce pain in people with diabetic peripheral neuropathy (DPN). Studies suggest that applying capsaicin to the skin is safe and effective for this type of pain. For instance, one study found that 60.8% of patients using capsaicin experienced a 30% reduction in pain after three weeks, compared to 42.1% who used a placebo. Another study showed that a capsaicin patch provided some pain relief over 12 weeks. In this trial, participants in the Capsadyn Arm will receive an over-the-counter topical cream with 0.25% capsaicin palmitate, while those in the Placebo Arm will receive a cream with no active ingredient. These findings suggest that capsaicin could be a promising option for managing painful diabetic neuropathy.25678
Who Is on the Research Team?
Robert Carpenter, MD
Principal Investigator
Carilion Clinic
Are You a Good Fit for This Trial?
This trial is for people between 25-75 years old with diabetic foot pain due to neuropathy, who have at least three toes per foot and intact feet without skin conditions that affect absorption. Participants must not be in other trials, use certain topical products, or have allergies to ingredients like chili peppers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants apply the topical cream (Capsadyn or placebo) twice daily for 14 days to assess pain reduction
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Capsaicin Palmitate
Trial Overview
The study tests a cream called Capsadyn®, which contains capsaicin palmitate, against a placebo to see if it reduces diabetic neuropathic foot pain. Participants will apply the cream twice daily and report their pain levels after waiting at least an hour post-application.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
participant will receive an over-the-counter topical cream with .25% capsaicin palmitate
participant will receive an over-the counter topical cream with no active ingredient
Find a Clinic Near You
Who Is Running the Clinical Trial?
Carilion Clinic
Lead Sponsor
Citations
Treatment of painful diabetic neuropathy with topical ...
Study results suggest that topical capsaicin cream is safe and effective in treating painful diabetic neuropathy.
CASPAR: a retrospective cohort study of the high- ...
This retrospective cohort study highlights the effectiveness of HCCTS treatment in patients with pDPN of the feet, demonstrating significant reductions in pain ...
Capsaicin 8% Patch in Painful Diabetic Peripheral ...
In patients with PDPN, a single capsaicin 8% patch treatment provided modest improvements in pain relief compared with a placebo patch over a period of 12 weeks ...
Treatment of Painful Diabetic Neuropathy With Topical ...
Study results suggest that topical capsaicin cream is safe and effective in treating painful diabetic neuropathy.
Capsaicinoids in the treatment of neuropathic pain: a review
A total of 60.8% of capsaicin-treated patients experienced 30% pain relief after 3 weeks of treatment (p < 0.02) versus 42.1% with placebo [Keitel et al. 2001].
Capsaicin 8% Patch in Painful Diabetic Peripheral ...
This 12-week study evaluated the efficacy and safety of capsaicin 8% patch versus placebo patch in painful diabetic peripheral neuropathy (PDPN).
A study to evaluate efficacy and safety of a single ...
The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves ...
8.
journals.lww.com
journals.lww.com/painrpts/fulltext/2025/04000/narrative_review_of_the_efficacy_and_safety_of_the.3.aspxNarrative review of the efficacy and safety of the... : PAIN ...
The results show that the HC capsaicin patch consistently provides pain relief and improves quality of life for several pNeP conditions, with increasing ...
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