Physiological Conditions
Conditions
Keywords
Skin, microcirculation; ASIC, pressure ulcer
Brief summary
Pressure ulcers are a common and costly problem. Advancing the understanding regarding the basic pathophysiological mechanisms mediating the development of pressure ulcers will allow for better delineation of populations at risk. Healthy skin is protected from pressure-induced ischemic damage because of the presence of pressure-induced vasodilation (PIV). In contrast, in absence of PIV, such as in diabetic patients or older subjects with sensory neuropathy, the skin is exposed to severe cutaneous ischemia, which could lead to pressure ulcer formation. Since Acid Sensing Ion channels (ASICs) appear to be involved in the cutaneous mechanosensitivity, the investigators hypothesized that PIV could be altered by treatments that block ASICs.
Interventions
DRUGDiclofenac
diclofenac 5% vs placebo (topical application) cutaneous blood flow measurement using laser Doppler
DRUGAmiloride
amiloride 1mM vs placebo (intradermal injection) cutaneous blood flow measurement using laser Doppler
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult males or females aged between 18 and 40 years of age
Exclusion criteria
* no consent, diabetes, neuropathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| evaluate the difference in the cutaneous microvascular response to local pressure application between treated (amiloride and diclofenac) and untreated skin. | Criteria will be measured 30 and 60 minutes following the injection of amiloride and the application of diclofenac, respectively. |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate difference in the cutaneous sensitivity and the cutaneous microvascular response to acetylcholine, sodium nitroprusside, electrical current and local heating between treated (amiloride and diclofenac) and untreated skin | Criteria will be measured 30 and 60 minutes following the injection of amiloride and the application of diclofenac, respectively. |
Countries
France
Outcome results
None listed