Microcirculation & ASICs

NCT01246180 | Completed

• 1 other identifier: 2009.554
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Physiological Conditions

Keywords

Skin, microcirculation; ASIC, pressure ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Diclofenac DRUG

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

Amiloride DRUG

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• no consent, diabetes, neuropathy.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Pôle d'activité medicale-Centre Hospitalier Lyon Sud-Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

Related Publications (1)

• Fromy B, Lingueglia E, Sigaudo-Roussel D, Saumet JL, Lazdunski M. Asic3 is a neuronal mechanosensor for pressure-induced vasodilation that protects against pressure ulcers. Nat Med. 2012 Aug;18(8):1205-7. doi: 10.1038/nm.2844. Epub 2012 Jul 29.

  PMID: 22842475 RESULT

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Diclofenac; Amiloride

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jean-Louis Saumet, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 28, 2019

Record last verified: 2011-07

Locations

FR (1)