We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Microcirculation & ASICs

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01246180
First Posted: November 23, 2010
Last Update Posted: July 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospices Civils de Lyon
  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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Study of the Cutaneous Microcirculation: ASIC Involvement.

Resource links provided by NLM:


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. ]

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. ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

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
First Submitted: November 22, 2010
First Posted: November 23, 2010
Last Update Posted: July 28, 2011
Last Verified: July 2011

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

Additional relevant MeSH terms:
Diclofenac
Amiloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing