The objective of the study comprises the identification of (tissue) biomarkers related to the risk of re-amputaion, systemic atehrosclerotic manifestations and woundhealing in patients with critical limb ischemia by investigating tissue biopts at…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study parameters have not been defined yet, a number of different proteins
will be investigated as well as histology including vessel density. These
parameters will be related to patient and follow-up data.
Follow-up parameters include:
1: re-amputation withing 3 years following primary amputation
2: woundinfection
3: duration of correct woundhealing ( days following surgery, within 6 weeks
after surgery)
Secondary outcome
A: Acute other manifestations of atherosclerosis (myocardial infarction,
cerbrsl infarction and peripheral intervention)
Background summary
Patients with critilcal limb ischemia (CLI), without medical or
interventional/surgical treatment options have an indication for amputation of
(part) the leg. Currently, amputation of the leg it concerns has to be
reoperaterated including an amputation at a higher level in a majority of
patients with CLI, because of impaired woundhealing or lokal infection.
Reampuations are essential in circumstances of unhealing or infected wounds,
since patient may become seriously ill.
Markers related to the ideal amputation level with good healing or predicting
correct woundhealing are lacking. Based on local tissue markers at the levels
of amputation (biomarkers - vene, artery, muscle, subcutis) we expect ot
identify biomarkers that enable risk prediction of re-amputation in patients
with CLI. In the clinical setting, these markers may serve as targets
determining the ideal level of amputation with good postoperative healing. This
approach will contribute to a reduction of the number of re-ampuations and
would predict correct woundhealing prior to the operation.
The outcome of the study will decrease hospitalization, number of operations
and its related complications. The outcome will improve patients rehabilitation
and reduce medical costs.
In addition the markers will be correlated with systemic cardiovascular
manifestations, since patients with peripheral artery disease have an
remarkable increased risk to suffer from systemic cardiovascular events.
Study objective
The objective of the study comprises the identification of (tissue) biomarkers
related to the risk of re-amputaion, systemic atehrosclerotic manifestations
and woundhealing in patients with critical limb ischemia by investigating
tissue biopts at the level of amputation.
Study design
Observational prospective cohort study
Study burden and risks
Besides the regular outpatient clinic visits concerning regular follow-up,
which is after 6 weeks and 3 months and yearly after the operation, patients
recieve a questionnair prior to the operation and during follow-up they will
receive half yearly a questionnaire with 5-10 questions related to the primary
and secundary endpoints of the study.
Prior to surgery general bloodsamples are taken form the patients for
pre-operative screening. For this study 30 ml of additional samples will be
collected. Patients should not be additionally pricked.
Heidelberglaan 100
3584 CX
NL
Heidelberglaan 100
3584 CX
NL
Listed location countries
Age
Inclusion criteria
Patients between 18-99 years old with critical limb ischemia and without medical treatment options, revascularization possibilities or exercise treatment.
Exclusion criteria
Younger than 18 years old, HIV positive patients
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 | NL37133.041.12 |