An observational study in Critical Limb Ischemia and Peripheral Arterial Disease, sponsored by Centre Hospitalier de Valenciennes. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-26.
Sponsored by Centre Hospitalier de Valenciennes · Observational
This study aims at evaluating the correlation between foot perfusion on angiographies performed before and after revascularization and limb salvage in patients with critical limb ischemia.
Critical limb ischemia (CLI) in diabetic patients is increasing drastically worldwide, and is already recognized as a major health issue. CLI is frequently leading to major amputations. Therefore, one of the key point to prevent limb loss is to restore a good vascularization to the foot, usually thanks to endovascular means.
No consensual indicator is currently available to estimate if the limb revascularization will be sufficient or not to prevent amputation, and to help physicians decide if they should be more aggressive during the endovascular procedure. Transcutaneous oximetry and value of the ankle-brachial index (ABI) are commonly used in the ward (not available in the operating room), but have shown poor correlation to wound healing or limb salvage and results are frequently biased because of the arterial wall calcifications due to diabetes. Value of the first toe systolic pressure is currently under evaluation to predict survival without amputation, with promising results, but cannot be applied to patients with wounds at this level or previous minor amputation.
The emergence of hybrid rooms in the operating theater offer access to high quality imaging and image post-treatment. Those capabilities could be used to analyze the flow and the tissue perfusion in the foot, and correlate those imaging parameters to positive clinical outcomes, such as wound healing, thus creating a useful tool to guide physicians in daily practice.
Differences between foot angiographies performed before and after revascularization could be used to estimate the quality of the revascularization and predict wound healing and limb salvage. This method would be directly available in the operating room and could help physicians to optimize their strategy during the procedure
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 69 is below the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Centre Hospitalier de Valenciennes is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients suffering from peripheral arterial disease in critical limb ischemia (Rutherford 4, 5 and 6) at the initial presentation, with a major risk of limb amputation at mid-term without revascularization.
Exclusion Criteria:
Number of participants with major amputation
Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)
Time frame: 1 month
Number of participants with major amputation
Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)
Time frame: 3 months
Number of participants with major amputation
Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)
Time frame: 6 months
Number of participants with major amputation
Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)
Time frame: 1 year
Wound Healing
Complete wound Healing at the level of the foot according to the WiFI classification
Time frame: 1 month
Wound Healing
Complete wound Healing at the level of the foot according to the WiFI classification
Time frame: 3 months
Wound Healing
Complete wound Healing at the level of the foot according to the WiFI classification
Time frame: 6 months
Wound Healing
Complete wound Healing at the level of the foot according to the WiFI classification
Time frame: 1 year
Number of patients with secondary intervention
Number of participants with a secondary intervention. Secondary intervention is defined as all secondary surgical interventions (both endovascular and open repairs) associated to critical limb ischemia on the same limb. It includes secondary angioplasties, bypasses or minor and major amputations. This is a clinical binary criterion (0= Freedom from secondary intervention, 1=At least one secondary intervention)
Time frame: 1 year
Overall Mortality
Overall Mortality, all-cause included
Time frame: 1 year
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier de Valenciennes