Diabetic Neuropathies, PainfulEarly Phase 1NCT07260656
Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain
A Early Phase 1 study testing Capsaicin Palmitate in people with Diabetic Neuropathies, Painful and Diabetic Foot, run by Carilion Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetic Neuropathies, Painful, Diabetic Foot, Diabetic Peripheral Neuropathy
- What is being tested?
- Capsaicin Palmitate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2025to Nov 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Must agree to apply the Test Article to feet as instructed 2x per day.
- Must wait 60 minutes after each application of Test Article before filling out NRS forms.
- Unless burning is encountered soon after application, the participant must wait at least 60 minutes before washing feet after application of Test Article.
- All participants must be willing to use Test Articles blinded.
Who cannot join
- 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.
- Unless part of a stable continuum of substance use prior to start of study, the use of any topical medication products on feet, including holistic formulations, patch or herbal products, cannabinoid products, prescription or over the-counter (OTC) analgesic creams/lotions/patches/gels, nonsteroidal anti-inflammatory drugs, acetaminophen, counterirritants, local anesthetics, or steroids is prohibited.
- Current substance abuse.
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- History of hypersensitivity or allergy to chili peppers, coconut oil, Shea butter, or sunflower seed oil.
- Except for interventions for mobility, (e.g., physical therapy, exercise, grounding) no concurrent foot therapy for pain that may interfere with NRS evaluations is permitted (e.g., massage, electrophoresis, red light, etc.).
- No concurrent enrollment in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24016
Internal Medicine, 540-224-5170
Robert Carpenter, MD
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Capsaicin Palmitate, Placebo
- Keywords
- diabetic foot pain
- Medical subject headings
- Diabetic Neuropathies, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin PalmitateDrug
Also called Capsadyn
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.
PlaceboDrug
Also called OTC topical cream
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 group | Role | What they receive |
|---|---|---|
| Capsadyn Arm | Active comparator | participant will receive an over-the-counter topical cream with .25% capsaicin palmitate Receives: Drug: Capsaicin Palmitate |
| Placebo Arm | Placebo comparator | participant will receive an over-the counter topical cream with no active ingredient Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start26 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathies, PainfulStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participant population will be scheduled for an even split between the two study arms.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Carpenter, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260656
- Sponsor's protocol ID
- IRB-25-2072
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07260656
- Acronym / sponsor ID
- IRB-25-2072
- Keywords
- diabetic foot pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The participant population will be scheduled for an even split between the two study arms.
| Arm | Type | Receives |
|---|---|---|
| Capsadyn Arm | Active comparator | Drug: Capsaicin Palmitateparticipant will receive an over-the-counter topical cream with .25% capsaicin palmitate |
| Placebo Arm | Placebo comparator | Drug: Placeboparticipant will receive an over-the counter topical cream with no active ingredient |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Must agree to apply the Test Article to feet as instructed 2x per day.
Key exclusion criteria (9 listed)
- 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.
- Unless part of a stable continuum of substance use prior to start of study, the use of any topical medication products on feet, including holistic formulations, patch or herbal products, cannabinoid products, prescription or over the-counter (OTC) analgesic creams/lotions/patches/gels, nonsteroidal anti-inflammatory drugs, acetaminophen, counterirritants, local anesthetics, or steroids is prohibited.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin PalmitateAlso: CapsadynParticipant 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 | Capsadyn Arm |
| PlaceboAlso: OTC topical creamParticipant 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 Arm |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Carpenter, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Capsaicin Palmitate in people with Diabetic Neuropathies, Painful and Diabetic Foot, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Autumn Weidman ((540) 240-1695, alweidman@carilionclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.