Microcirculation & ASICs
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|ClinicalTrials.gov Identifier: NCT01246180|
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : July 28, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Physiological Conditions||Drug: Diclofenac Drug: Amiloride||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Study of the Cutaneous Microcirculation: ASIC Involvement.|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
- evaluate the difference in the cutaneous microvascular response to local pressure application between treated (amiloride and diclofenac) and untreated skin. [ Time Frame: Criteria will be measured 30 and 60 minutes following the injection of amiloride and the application of diclofenac, respectively. ]
- 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 [ Time Frame: Criteria will be measured 30 and 60 minutes following the injection of amiloride and the application of diclofenac, respectively. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246180
|Pôle d'activité medicale-Centre Hospitalier Lyon Sud-Hospices Civils de Lyon|
|Pierre Bénite, France, 69495|
|Principal Investigator:||Jean-Louis Saumet, Pr||Hospices Civils de Lyon|