AmputationNCT03539120
Post-amputation Survival Following Rehabilitation Medium and Long-term Follow up Study, a Retrospective Analysis.
An observational study of Amputation, run by Changi General Hospital.
Trial summary
This is a retrospective data analysis of patients who underwent lower limb amputation and rehabilitation and follow up. Investigators analysed their survival outcomes in relation to various comorbidities i. e ischaemic heart disease, renal impairment, vascular interventions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amputation
- What is being tested?
- Follow up for survival
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 24 Mar 2016to 31 Jan 2018
- Phase
- Observational
- 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 Any age
- Child, Adult, Older adult
Study population: This study aimed to analyse survival outcome in patients with dysvascular lower limb amputation and identify relationship with existing comorbidities, i.e. diabetes mellitus (DM), peripheral vascular disease (PVD), ischaemic heart disease (IHD), estimated glomerular filtration rate (e-GFR), and chronic kidney disease (CKD). We also analysed the length of hospital stay, linear relationship with duration of DM, and vascular interventions.
Who may be able to join
- Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.
Who cannot join
- Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records
About this study
Official title: Prognosticating Outcomes in Stroke, Acquired Brain Injury, Amputee and Other Neurological Impairments
This is a retrospective data analysis of patients who underwent lower limb amputation and rehabilitation and follow up.
Investigators analysed their survival outcomes in relation to various comorbidities i. e ischaemic heart disease, renal impairment, vascular interventions.
Read the detailed description
Inclusion criteria: Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.
Exclusion criteria: Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records.
- Conditions
- Amputation
- Being tested
- Follow up for survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up for survivalOther
No intervention, this is an observational study of survival outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
survival in relation to time
Survival outcomes were analysed and have been included in the results.
Measured: 6 months to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start24 Mar 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shrikant Pande, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539120
- Sponsor's protocol ID
- 201511-00072
- Status last verified
- Apr 2018
- First submitted
- 3 May 2018
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosticating Outcomes in Stroke, Acquired Brain Injury, Amputee and Other Neurological Impairments
- ClinicalTrials.gov ID
- NCT03539120
- Acronym / sponsor ID
- 201511-00072
- Conditions
- Amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 29 May 2018 (actual)
- 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.
This is a retrospective data analysis of patients who underwent lower limb amputation and rehabilitation and follow up.
Investigators analysed their survival outcomes in relation to various comorbidities i. e ischaemic heart disease, renal impairment, vascular interventions.
Detailed description
Inclusion criteria: Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.
Exclusion criteria: Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- This study aimed to analyse survival outcome in patients with dysvascular lower limb amputation and identify relationship with existing comorbidities, i.e. diabetes mellitus (DM), peripheral vascular disease (PVD), ischaemic heart disease (IHD), estimated glomerular filtration rate (e-GFR), and chronic kidney disease (CKD). We also analysed the length of hospital stay, linear relationship with duration of DM, and vascular interventions.
Key inclusion criteria (1 listed)
- Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.
Key exclusion criteria (1 listed)
- Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records
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 |
|---|---|---|
| Follow up for survivalNo intervention, this is an observational study of survival outcomes. | Other | – |
Primary outcome
survival in relation to time
Time frame: 6 months to 6 years
Survival outcomes were analysed and have been included in the results.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, run by Changi General Hospital.
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 1 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: finished, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
survival in relation to time (time frame: 6 months to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2018.