Microcirculation & ASICs

Study of the Cutaneous Microcirculation: ASIC Involvement.

Sponsors

Lead Sponsor: Hospices Civils de Lyon

Source 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.

Overall Status Completed
Start Date October 2010
Completion Date December 2010
Primary Completion Date December 2010
Phase N/A
Study Type Interventional
Primary Outcome
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 Outcome
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.
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: Diclofenac

Description: diclofenac 5% vs placebo (topical application) cutaneous blood flow measurement using laser Doppler

Intervention Type: Drug

Intervention Name: Amiloride

Description: amiloride 1mM vs placebo (intradermal injection) cutaneous blood flow measurement using laser Doppler

Eligibility

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- no consent, diabetes, neuropathy.

Gender: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Jean-Louis Saumet, Pr Principal Investigator Hospices Civils de Lyon
Location
Facility: Pôle d'activité medicale-Centre Hospitalier Lyon Sud-Hospices Civils de Lyon
Location Countries

France

Verification Date

July 2011

Responsible Party

Name Title: Pr Jean Louis SAUMET

Organization: Pôle d'activité médicale-Centre Hospitalier Lyon Sud-Hospices Civils de Lyon & Laboratoire de Physiologie - FRE CNRS 3075-Université Claude Bernard Lyon 1

Keywords
Has Expanded Access No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov