Physiological ResponsesNCT07237022
The Role of TRP Channels in DPN
An observational study of Physiological Responses, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The study aims to characterize the vascular response upon topical application of cinnamaldehyde, allyl isothiocyanate and capsaicin on feet skin in healthy volunteers. The vascular response will be characterized in terms of response over time, dose-response, inter-foot and inter-period reproducibility. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Responses
- What is being tested?
- Cinnamaldehyde, Allyl isothiocyanate (AITC) and Capsaicin
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Oct 2025to 31 Aug 2026
- Phase
- Observational
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy male and female volunteers aged 18 to 45 years (inclusive)
Who may be able to join
- Subject is a white male or female ≥18 and ≤45 years of age
- Subject is a non-smoker for at least 6 months prior to the start of the study
- Subject has a body mass index (BMI) between 18-30 kg/m²
- Subject is judged to be in good general health on the basis of medical history, physical examination and vital signs
- Subject understands the procedures and agrees to participate in the study by giving written informed consent.
Who cannot join
- Subject has a history of any illness or disorder which, in the investigator's opinion, might confound the results of the study
- Subject has a history of significant severe (drug) allergies
- Subject is a female who is pregnant, breast-feeding or intends to become pregnant, or is of child-bearing potential and is not using an adequate contraceptive method
- Subject uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study
- Subject currently uses lotions, oils, depilatory preparations, makeup, or other topical treatments on the feet on a regular basis which cannot be discontinued for the duration of the study
- Subject has eczema, scleroderma, psoriasis, dermatitis or keloids, tumors, ulcers, burns, skin flaps or grafts on the volar surface of the forearm or the dorsum of the feet, or any other skin abnormality that, in the opinion of the investigator, may interfere with the study assessments
Show all 12Show fewer
- Subject has excessive hair growth on the volar surface of the forearms or the dorsum of the feet
- Subject has any of the following vital sign measurements at screening after at least 10 minutes of supine rest: Heart Rate <40 or >100 beats/min, Diastolic Blood Pressure <50 or >90 mmHg, Systolic Blood Pressure <90 or >140 mmHg
- Subject is unable to refrain from drinking caffeinated beverages (e.g. coffee, tea, cola, …) 24 hours prior to each study visit. Subject is unable to limit their intake of caffeinated beverages to ≤4 cups a day throughout the study
- Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, is currently a regular user of illegal drugs, or has a history of substance abuse (including alcohol)
- Subject is currently participating or has been involved in testing an investigational drug in another clinical study within the last 4 weeks
- Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with safe and optimal participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Center for Clinical Pharmacology
Leuven, 3000
Heleen Marynissen, +3216347014, heleen.marynissen@uzleuven.be
About this study
Official title: The Role of Transient Receptor Potential Channels in Diabetic Peripheral Neuropathy
The study aims to characterize the vascular response upon topical application of cinnamaldehyde, allyl isothiocyanate and capsaicin on feet skin in healthy volunteers. The vascular response will be characterized in terms of response over time, dose-response, inter-foot and inter-period reproducibility.
- Conditions
- Physiological Responses
- Being tested
- Cinnamaldehyde, Allyl isothiocyanate (AITC), Capsaicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinnamaldehydeOther
A 10% and 30% cinnamaldehyde solution is topically applied on foot skin.
Allyl isothiocyanate (AITC)Other
A 15% and up to 30% AITC solution is topically applied on foot skin.
CapsaicinOther
A 1.5% and 5% capsaicin solution is topically applied on foot skin.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermal Blood Flow response (PU)
The DBF response prior to and at each point in time after topical application of cinnamaldehyde, AITC and capsaicin on the foot, assessed with LSCI, within the area of application, expressed in arbitrary perfusion units (PU).
Measured: Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.
Flare area (mm²)
The flare area of the DBF response prior to and at each point in time after topical application of cinnamaldehyde, AITC and capsaicin on the feet, assessed with LSCI.
Measured: Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.
Secondary outcomes (1)
Numeric Rating Scale (NRS) pain score
The Numeric Rating Scale (NRS)-11 pain score at each point in time after topical application of cinnamaldehyde, AITC and capsaicin on the feet.
Measured: Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start8 Oct 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological ResponsesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237022
- Sponsor's protocol ID
- CCP24-3303-DPN
- Status last verified
- Jun 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Transient Receptor Potential Channels in Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07237022
- Acronym / sponsor ID
- CCP24-3303-DPN
- Conditions
- Physiological Responses
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 19 Nov 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 study aims to characterize the vascular response upon topical application of cinnamaldehyde, allyl isothiocyanate and capsaicin on feet skin in healthy volunteers. The vascular response will be characterized in terms of response over time, dose-response, inter-foot and inter-period reproducibility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy male and female volunteers aged 18 to 45 years (inclusive)
Key inclusion criteria (5 listed)
- Subject is a white male or female ≥18 and ≤45 years of age
- Subject is a non-smoker for at least 6 months prior to the start of the study
- Subject has a body mass index (BMI) between 18-30 kg/m²
- Subject is judged to be in good general health on the basis of medical history, physical examination and vital signs
- Subject understands the procedures and agrees to participate in the study by giving written informed consent.
Key exclusion criteria (12 listed)
- Subject has a history of any illness or disorder which, in the investigator's opinion, might confound the results of the study
- Subject has a history of significant severe (drug) allergies
- Subject is a female who is pregnant, breast-feeding or intends to become pregnant, or is of child-bearing potential and is not using an adequate contraceptive method
- Subject uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study
- Subject currently uses lotions, oils, depilatory preparations, makeup, or other topical treatments on the feet on a regular basis which cannot be discontinued for the duration of the study
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 |
|---|---|---|
| CinnamaldehydeA 10% and 30% cinnamaldehyde solution is topically applied on foot skin. | Other | – |
| Allyl isothiocyanate (AITC)A 15% and up to 30% AITC solution is topically applied on foot skin. | Other | – |
| CapsaicinA 1.5% and 5% capsaicin solution is topically applied on foot skin. | Other | – |
Primary outcome
Dermal Blood Flow response (PU)
Time frame: Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.
The DBF response prior to and at each point in time after topical application of cinnamaldehyde, AITC and capsaicin on the foot, assessed with LSCI, within the area of application, expressed in arbitrary perfusion units (PU).
Flare area (mm²)
Time frame: Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.
The flare area of the DBF response prior to and at each point in time after topical application of cinnamaldehyde, AITC and capsaicin on the feet, assessed with LSCI.
1 secondary outcome
Numeric Rating Scale (NRS) pain score
Time frame: Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.
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 19 Nov 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physiological Responses, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 inclusion and 12 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 19 Nov 2025. 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 Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Heleen Marynissen (+3216347014, heleen.marynissen@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermal Blood Flow response (PU) (time frame: Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.). The study lists 2 primary outcomes in all. 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 19 Nov 2025.