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Microcirculation & ASICs

This study has been completed.
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01246180
First received: November 22, 2010
Last updated: July 27, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Physiological Conditions
 Drug: Diclofenac
Drug: Amiloride

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Study of the Cutaneous Microcirculation: ASIC Involvement.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Diclofenac
    diclofenac 5% vs placebo (topical application) cutaneous blood flow measurement using laser Doppler
    Drug: Amiloride
    amiloride 1mM vs placebo (intradermal injection) cutaneous blood flow measurement using laser Doppler
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no consent, diabetes, neuropathy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246180

Locations
France
Pôle d'activité medicale-Centre Hospitalier Lyon Sud-Hospices Civils de Lyon
Pierre Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Jean-Louis Saumet, Pr Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Pr Jean Louis SAUMET, Pôle d'activité médicale-Centre Hospitalier Lyon Sud-Hospices Civils de Lyon & Laboratoire de Physiologie - FRE CNRS 3075-Université Claude Bernard Lyon 1
ClinicalTrials.gov Identifier: NCT01246180     History of Changes
Other Study ID Numbers: 2009.554
Study First Received: November 22, 2010
Last Updated: July 27, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Skin, microcirculation; ASIC, pressure ulcer

Additional relevant MeSH terms:
Amiloride
Diclofenac
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013