The purpose of this study is to make it possible to make a prediction of risk of amputation stump wound healing without the need for re-intervention and whether a secondary amputation.
ID
Source
Brief title
Condition
- Other condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Health condition
Verbeteren van kwaliteit van leven
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Those patients within 100 days are back for a re-intervention and / or a
secondary amputation will be considered as bad recovering patients. Patients
who have a good recovery are the patients who do not re-intervention and or
secondary amputation need within 100 days. These two groups will be compared
with each other and with a third group of healthy controls.
By comparing the blood and tissue from different groups biomakers wil be
identified that can predict the chance of cure of an amputation wound.
Secondary outcome
.
Background summary
Peripheral arterial disease (PAD) is an important health issue. Despite current
treatment options based on vascular interventions, therapeutic options for
severe PAD remain limited. Critical limb ischemia (CLI) is the most severe form
of PAD and many patients are not candidate for surgery and it can lead to
amputation of the leg. However a delayed or a nonhealing amputation wound is a
serious additional problem and may require a secondary amputation.
Study objective
The purpose of this study is to make it possible to make a prediction of risk
of amputation stump wound healing without the need for re-intervention and
whether a secondary amputation.
Study design
To be able to make this prediction, in this observational study the expression
patterns of pro- and anti-angiogenic factors in blood, muscle and vascular
tissue from amputated limbs of PAD patients will be compared. The expression
patterns in blood and tissue of PAD patients will also be compared with that of
"healthy" controls (a non-PAD patient who for other reasons, for example, a
trauma, undergo an amputation).
After obtaining informed consent additional blood samples will be taken for
plasma and DNA samples. Subsequently, in the operating room, immediately after
the performance of the amputation, biopsies will be taken from different places
in the amputated leg.
Study burden and risks
.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
Patients older than 18 years who undergo amputation of the lower leg
Exclusion criteria
Mental incompetence and amputation due malignancy in the leg
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL41491.058.12 |