Microcirculation & ASICs

Not Applicable

Completed

• Conditions: Physiological Conditions

• Registration Number: NCT01246180
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-23
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-07
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy adult males or females aged between 18 and 40 years of age

Exclusion Criteria

• no consent, diabetes, neuropathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pôle d'activité medicale-Centre Hospitalier Lyon Sud-Hospices Civils de Lyon; 🇫🇷 Pierre Bénite, France