To assess the level of functional status of patients with critical limb ischemia after percutaneous revascularization or bypass surgery and major amputation and to identify subgroups that might benefit from primary amputation instead of…
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 main endpoint is the functional ability and QoL of patients 6 months and
one year after intervention (lower limb amputation or revascularization
procedure).
Secondary outcome
Secondary endpoint is the assessment in terms of physiological and mobility
parameters.
Background summary
The outcome of treatment of critical limb ischemia is usually expressed in
physiological parameters (ankle/brachial index (ABI), patency), however,
patient*s level of functional outcome and health-related quality of life (QoL)
are gaining more interest.
Critical limb ischemia is the end-stage of peripheral arterial disease. The
primary goal of treatment is limb salvage. Much effort is put in attempts for
revascularization. However, in certain cases the price paid for limb salvage is
high; revascularization in some patients ends up in long hospital stay and
several interventions. In these cases primary or secondary amputation is a
reasonable alternative. This emphasizes the need for identification of patient
groups in which amputation is preferable instead of revascularization.
Study objective
To assess the level of functional status of patients with critical limb
ischemia after percutaneous revascularization or bypass surgery and major
amputation and to identify subgroups that might benefit from primary amputation
instead of revascularization.
Study design
A prospective observational study.
Study burden and risks
Patients are needed to attend two follow-up time points. They were asked to
fill in a questionnaire and measurements (for instance ABI) will be done as
part of orderly treatment. Because of its observational design there are no
risks associated with participating. There are no benefits associated with
participating.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Critical limb ischemia requiring therapy consisting of either a bypass or PTA or major lower limb amputation (below, through, above knee).
Age 18 years or older.
Exclusion criteria
Unable to fill-in self-reported questionnaires (insufficiently reading or speaking the Dutch language, cognitive disorders, etc).
Life-expectancy less than 3 months.
Legally incompetent adults.
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 | NL16964.018.07 |