Diagnostic Techniques, CardiovascularNCT00907712
Cardiovascular Assessment Before and After Limb Amputation
A study testing cardiac echo examination in people with Diagnostic Techniques, Cardiovascular, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Vascular lower limb amputees have an increased morbidity and mortality. The aim of the study is to evaluate the hemodynamic changes after amputation and its relation to outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnostic Techniques, Cardiovascular
- What is being tested?
- cardiac echo examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- May 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all vascular or diabetic patients before leg amputation
Who cannot join
- traumatic amputation
- sepsis patient
- urgent surgery
Trial locations and contacts
1 site in 1 country.
About this study
Vascular lower limb amputees have an increased morbidity and mortality. The aim of the study is to evaluate the hemodynamic changes after amputation and its relation to outcome.
- Conditions
- Diagnostic Techniques, Cardiovascular
- Being tested
- cardiac echo examination
- Keywords
- amputation, vascular, below knee, above knee, cardiovascular, echo, cardiovascular assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac echo examinationOther
cardiac echo examination - before and after the surgery
| Study group | Role | What they receive |
|---|---|---|
| cardiovascular | No intervention | cardiac echo Receives: Other: cardiac echo examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular assessment
Measured: week
Secondary outcomes (1)
complications
Measured: month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Department difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diagnostic Techniques, CardiovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907712
- Sponsor's protocol ID
- 10-09
- Status last verified
- Jun 2015
- First submitted
- 18 May 2009
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Izumi Y, Satterfield K, Lee S, Harkless LB. Risk of reamputation in diabetic patients stratified by limb and level of amputation: a 10-year observation. Diabetes Care. 2006 Mar;29(3):566-70. doi: 10.2337/diacare.29.03.06.dc05-1992.
PubMed 16505507Izumi Y, Satterfield K, Lee S, Harkless LB, Lavery LA. Mortality of first-time amputees in diabetics: a 10-year observation. Diabetes Res Clin Pract. 2009 Jan;83(1):126-31. doi: 10.1016/j.diabres.2008.09.005. Epub 2008 Dec 20.
PubMed 19097667Remes L, Isoaho R, Vahlberg T, Hiekkanen H, Korhonen K, Viitanen M, Rautava P. Major lower extremity amputation in elderly patients with peripheral arterial disease: incidence and survival rates. Aging Clin Exp Res. 2008 Oct;20(5):385-93. doi: 10.1007/BF03325142.
PubMed 19039278Papazafiropoulou A, Tentolouris N, Soldatos RP, Liapis CD, Dounis E, Kostakis AG, Bastounis E, Katsilambros N. Mortality in diabetic and nondiabetic patients after amputations performed from 1996 to 2005 in a tertiary hospital population: a 3-year follow-up study. J Diabetes Complications. 2009 Jan-Feb;23(1):7-11. doi: 10.1016/j.jdiacomp.2007.11.008. Epub 2008 Apr 16.
PubMed 18413176
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Assessment Before and After Limb Amputation
- ClinicalTrials.gov ID
- NCT00907712
- Acronym / sponsor ID
- 10-09
- Conditions
- Diagnostic Techniques, Cardiovascular
- Keywords
- amputation, vascular, below knee, above knee, cardiovascular, echo, cardiovascular assessment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Department difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vascular lower limb amputees have an increased morbidity and mortality. The aim of the study is to evaluate the hemodynamic changes after amputation and its relation to outcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiovascular | No intervention | Other: cardiac echo examinationcardiac echo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all vascular or diabetic patients before leg amputation
Key exclusion criteria (3 listed)
- traumatic amputation
- sepsis patient
- urgent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac echo examinationcardiac echo examination - before and after the surgery | Other | cardiovascular |
Primary outcome
cardiovascular assessment
Time frame: week
1 secondary outcome
complications
Time frame: month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Background: PubMed 16505507Izumi Y, Satterfield K, Lee S, Harkless LB. Risk of reamputation in diabetic patients stratified by limb and level of amputation: a 10-year observation. Diabetes Care. 2006 Mar;29(3):566-70. doi: 10.2337/diacare.29.03.06.dc05-1992.
- Background: PubMed 19097667Izumi Y, Satterfield K, Lee S, Harkless LB, Lavery LA. Mortality of first-time amputees in diabetics: a 10-year observation. Diabetes Res Clin Pract. 2009 Jan;83(1):126-31. doi: 10.1016/j.diabres.2008.09.005. Epub 2008 Dec 20.
- Background: PubMed 19039278Remes L, Isoaho R, Vahlberg T, Hiekkanen H, Korhonen K, Viitanen M, Rautava P. Major lower extremity amputation in elderly patients with peripheral arterial disease: incidence and survival rates. Aging Clin Exp Res. 2008 Oct;20(5):385-93. doi: 10.1007/BF03325142.
- Background: PubMed 18413176Papazafiropoulou A, Tentolouris N, Soldatos RP, Liapis CD, Dounis E, Kostakis AG, Bastounis E, Katsilambros N. Mortality in diabetic and nondiabetic patients after amputations performed from 1996 to 2005 in a tertiary hospital population: a 3-year follow-up study. J Diabetes Complications. 2009 Jan-Feb;23(1):7-11. doi: 10.1016/j.jdiacomp.2007.11.008. Epub 2008 Apr 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac echo examination in people with Diagnostic Techniques, Cardiovascular, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular assessment (time frame: week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00907712, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015; AzTrials last refreshed its copy on 27 Oct 2026.