Actively Recruiting

Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT07237022

The Role of TRP Channels in DPN

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-11-19

20

Participants Needed

1

Research Sites

46 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

The Role of TRP Channels in DPN

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject is a white male or female 18 to 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 based on medical history, physical exam, and vital signs
  • Subject understands the procedures and agrees to participate by giving written informed consent
Not Eligible

You will not qualify if you...

  • History of illness or disorder that might affect study results
  • History of significant severe drug allergies
  • Female who is pregnant, breastfeeding, or intends to become pregnant without adequate contraception
  • Regular use of prescription or non-prescription drugs that might affect study results
  • Regular use of lotions, oils, depilatory products, makeup, or other topical treatments on feet that cannot be stopped
  • Presence of eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, skin flaps or grafts on forearm or feet skin, or other skin abnormalities interfering with assessments
  • Excessive hair growth on forearms or feet
  • Vital signs outside specified ranges after rest: heart rate <40 or >100 bpm, diastolic BP <50 or >90 mmHg, systolic BP <90 or >140 mmHg
  • Inability to limit caffeine intake to 4 cups a day and refrain from caffeine 24 hours before visits
  • Inability to refrain from alcohol 24 hours before visits, regular illegal drug use, or history of substance abuse
  • Participation in another investigational drug study within last 4 weeks
  • Any condition or situation that may interfere with safe and optimal participation according to investigator's opinion

AI-Screening

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Trial Site Locations

Total: 1 location

1

Center for Clinical Pharmacology

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

H

Heleen Marynissen

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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