Microcirculation & ASICs

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT01246180
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 2
• Patients Per Site Per Month: 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Physiological Conditions	Drug: Diclofenac; Drug: Amiloride	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• 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.
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• no consent, diabetes, neuropathy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01246180
• Other Study ID Numbers: 2009.554
• First Posted: Nov 23, 2010
• Last Update Posted: May 28, 2019
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: Skin, microcirculation; ASIC, pressure ulcer
• Additional relevant MeSH terms: Diclofenac; Amiloride

Study Results

No Results Posted as of May 28, 2019