Microcirculation & ASICs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Physiological Conditions

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Diclofenac

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

Intervention Type DRUG

Amiloride

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* no consent, diabetes, neuropathy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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