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OpenTrials
Completed

NCT Number: NCT01246180

Microcirculation & ASICs

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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Key information

Conditions

Physiological Conditions Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pierre-Bénite, 69495, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • no consent, diabetes, neuropathy.

Treatment and study plan

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

Primary outcomes

  1. 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 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

    Time frame: Criteria will be measured 30 and 60 minutes following the injection of amiloride and the application of diclofenac, respectively.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Study of the Cutaneous Microcirculation: ASIC Involvement.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 23, 2010
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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