Chronic Critical IschemiaELITNCT01634815
Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization
A study testing The Edge in people with Chronic Critical Ischemia, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
Evaluation of a new biological criterion, the local capillary blood lactates to optimize the management of patients with chronic critical ischemia requiring revascularization fast. Potential use in terms of capillary blood lactate as a diagnostic indicator of recurrent ischemia in a limb revascularized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Critical Ischemia
- What is being tested?
- The Edge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Feb 2013to 21 Aug 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemia Chronic critical lower limb revascularization procedure requiring fast.
- Written consent informed patient age greater than or equal to 18
Who cannot join
- Presence of an inflammatory or infectious (erysipelas) in the ischemic member.
- Patients at risk for diabetic foot ie, as defined by the HAS (preventing diabetic foot, 2007)
- presence of sensory neuropathy, and / or
- foot deformities (hallux valgus, hammer toes or claw, prominence of the metatarsal heads), and / or
- history of foot ulceration, and / or
- antecedent of one of these factors (ie antécedant diabetic foot).
Show all 14Show fewer
- Necrosis of the toes.
- Participation in another clinical research protocol.
- Presence of peripheral arterial disease in the bilateral upper limbs.
- Patient in shock whatever the cause.
- Presence of hepatic failure.
- Too impaired general condition (bedridden, dementia, ...)
- Refusal of the patient to participate in the study
- Protected patients
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique de l'Orangerie
Strasbourg, 67000
Hôpitaux Universitaires de Strasbourg, Service d' Anesthésie Réanimation Chirurgicale
Strasbourg, 67091
About this study
Official title: Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization.
Evaluation of a new biological criterion, the local capillary blood lactates to optimize the management of patients with chronic critical ischemia requiring revascularization fast. Potential use in terms of capillary blood lactate as a diagnostic indicator of recurrent ischemia in a limb revascularized.
- Conditions
- Chronic Critical Ischemia
- Being tested
- The Edge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The EdgeProcedure or surgery
measuring blood lactate
| Study group | Role | What they receive |
|---|---|---|
| lactate group | Experimental | Not described Receives: Procedure: The Edge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD)
Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD) before revascularization of the lower limb in chronic critical limb ischemia (considered positive if> 2).
Measured: 48 hours
Secondary outcomes (1)
The decrease in the ratio LCO/LCD
The decrease in the ratio LCO / LCD in the immediate aftermath of revascularization
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study start4 Feb 2013
- Primary completion21 Aug 2015
- Study completion21 Aug 2015
Why it stopped: Enrollment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Critical IschemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Diemunsch, MD, Principal investigator, not affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634815
- Sponsor's protocol ID
- 5244
- Acronym
- ELIT
- Status last verified
- Feb 2018
- First submitted
- 2 Jul 2012
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization.
- ClinicalTrials.gov ID
- NCT01634815
- Acronym / sponsor ID
- ELIT / 5244
- Conditions
- Chronic Critical Ischemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment difficulties
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Feb 2013 (actual)
- Primary completion
- 21 Aug 2015 (actual)
- Study completion
- 21 Aug 2015 (actual)
- First posted
- 6 Jul 2012 (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.
Evaluation of a new biological criterion, the local capillary blood lactates to optimize the management of patients with chronic critical ischemia requiring revascularization fast. Potential use in terms of capillary blood lactate as a diagnostic indicator of recurrent ischemia in a limb revascularized.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lactate group | Experimental | Procedure: The Edge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ischemia Chronic critical lower limb revascularization procedure requiring fast.
- Written consent informed patient age greater than or equal to 18
Key exclusion criteria (14 listed)
- Presence of an inflammatory or infectious (erysipelas) in the ischemic member.
- Patients at risk for diabetic foot ie, as defined by the HAS (preventing diabetic foot, 2007)
- Necrosis of the toes.
- Participation in another clinical research protocol.
- Presence of peripheral arterial disease in the bilateral upper limbs.
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 |
|---|---|---|
| The Edgemeasuring blood lactate | Procedure or surgery | lactate group |
Primary outcome
Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD)
Time frame: 48 hours
Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD) before revascularization of the lower limb in chronic critical limb ischemia (considered positive if> 2).
1 secondary outcome
The decrease in the ratio LCO/LCD
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: Enrollment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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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.
Pierre Diemunsch, MD principal investigator
not affiliated
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Edge in people with Chronic Critical Ischemia, run by University Hospital, Strasbourg, France at 2 sites 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 2 inclusion and 14 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: stopped early, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Enrollment difficulties). Results are not available in the source record.
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?
Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2018.