To assess the effectiveness of treatment of patients with CLI comparing best supportive care and best supportive care with surgical or endovascular revascularization. This in order to identify patientgroups in which an intervention may not be…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are amputation free survival (AFS) and patient reported
outcomes measures (PROMS) after 12 months follow-up.
Secondary outcome
* Wound healing (complete epithelialization)
* Overall survival
* Limb salvage
* Major amputation (proximal to the level of the ankle)
* Minor amputation (toe, forefoot)
* Resource utilization (outpatient visits, need for rehabilitation, nursing
home care).
* Events (reinterventions, readmissions)
* Cost of care within 12 months
Background summary
Critical limb ischemia (CLI) is an advanced stage of peripheral arterial
disease of the lower extremity, characterized by ischemic pain, gangrene or
tissue loss, which carries a high risk of amputation. In addition, patients
with CLI have a poor overall prognosis due to advanced age and comorbidities.
Treatment of CLI consists of antibiotics, wound debridement and endovascular or
surgical revascularization. However, revascularization is probably not
necessary for a substantial number of patients for limb salvage, pain relief,
wound healing and to improve quality of life, but are certainly more costly and
burdensome than the non-interventional option.
Study objective
To assess the effectiveness of treatment of patients with CLI comparing best
supportive care and best supportive care with surgical or endovascular
revascularization. This in order to identify patientgroups in which an
intervention may not be necessary.
Study design
Prospective observational multicenter cohort study with 12 months of follow-up.
Study burden and risks
Not applicable
Meibergdreef 9
Amsterdam Zuid-Oost 1105 AZ
NL
Meibergdreef 9
Amsterdam Zuid-Oost 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Critical limb ischemia is defined as following;
Patients must have ischemic rest pain, tissue loss, ulcer or gangrene. Symptoms
have to be present for more than two weeks at time of enrollment. PAD must be
confirmed by one of the following;
* Absolute systolic ankle pressure < 70 mmHg
* Systolic Toe Pressure < 50 mmHg
* Transcutaneous oxygen pressure (tcPO2) < 50 mmHg
* One or more significant (>50%) obstructions in the iliac or lower limb
arteries as found with non-invasive imaging (duplex ultrasonography (DUS),
Magnetic Resonance Angiography (MRA), Computed Tomography Angiography (CTA)) or
digital subtraction angiography (DSA)
* Written informed consent
Exclusion criteria
In the case of meeting any of the following criteria patients will be excluded
from enrollment.
* Acute ischemia; due to emboli or trauma
* Non-atherosclerotic origin of ischemia; arteritis, thrombangitis obliterans
(Buerger*s disease)
* Hypercoagulable states
* Venous ulcer
* Insufficient proficiency of Dutch language, or inability to complete the
Dutch questionnaires
* In the case of bilateral affected limbs, the least affected limb will be
excluded.
* Ipsilateral peripheral revascularization intervention of the affected limb
within the last three months before presentation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62489.018.17 |
| Other | Wordt geregistreerd onder NCT, NRT nummer volgt |