Physiological ConditionsNCT01246180
Microcirculation & ASICs
A study testing Diclofenac and Amiloride in people with Physiological Conditions, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Conditions
- What is being tested?
- Diclofenac and Amiloride
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males or females aged between 18 and 40 years of age
Who cannot join
- no consent, diabetes, neuropathy.
Trial locations and contacts
1 site in 1 country.
France1 site
Pôle d'activité medicale-Centre Hospitalier Lyon Sud-Hospices Civils de Lyon
Pierre-Bénite, 69495
About this study
Official title: Study of the Cutaneous Microcirculation: ASIC Involvement.
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
- Being tested
- Diclofenac, Amiloride
- Keywords
- Skin, microcirculation; ASIC, pressure ulcer
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
diclofenac 5% vs placebo (topical application) cutaneous blood flow measurement using laser Doppler
AmilorideDrug
amiloride 1mM vs placebo (intradermal injection) cutaneous blood flow measurement using laser Doppler
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the difference in the cutaneous microvascular response to local pressure application between treated (amiloride and diclofenac) and untreated skin.
Measured: 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
Measured: Criteria will be measured 30 and 60 minutes following the injection of amiloride and the application of diclofenac, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physiological ConditionsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Louis Saumet, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246180
- Sponsor's protocol ID
- 2009.554
- Status last verified
- Jul 2011
- First submitted
- 22 Nov 2010
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22842475
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Cutaneous Microcirculation: ASIC Involvement.
- ClinicalTrials.gov ID
- NCT01246180
- Acronym / sponsor ID
- 2009.554
- Conditions
- Physiological Conditions
- Keywords
- Skin, microcirculation; ASIC, pressure ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adult males or females aged between 18 and 40 years of age
Key exclusion criteria (1 listed)
- no consent, diabetes, neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenacdiclofenac 5% vs placebo (topical application) cutaneous blood flow measurement using laser Doppler | Drug | – |
| Amilorideamiloride 1mM vs placebo (intradermal injection) cutaneous blood flow measurement using laser Doppler | Drug | – |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Results publication: PubMed 22842475Fromy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis Saumet, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diclofenac and Amiloride in people with Physiological Conditions, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01246180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.