Quality of LifeNCT03570788
HRQoL Among Patients Amputated Due to Peripheral Arterial Disease
An observational study of Quality of Life and Amputation, run by Jonas Malmstedt at 1 site in Sweden.
Trial summary
A prospective cohort study over the prosthetic use among patients amputated after vascular disease and the impact of their HRQoL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Amputation, Peripheral Arterial Disease
- What is being tested?
- Amputation
- Type of treatment
- Surgery or procedure
- How many people
- 98 participants
- Where
- 1 siteSweden
- Study dates
- 12 Sep 2014to 20 May 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients amputated at Södersjukhuset during 2014-2018 are reviewed based on criteria for inclusion and exclusion. All patients that meets the inclusion criteria during the period will be contacted by the researcher in connection with the amputation and informed about the study.
Who may be able to join
- Patients amputated at femoral, knee or tibial level due to peripheral arterial disease
Who cannot join
- Patients not able to provide informed consent
- Patients not able to verbally express their experience of the amputation.
- Patients that not speak Swedish
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet
Stockholm, SE-118 83
About this study
Official title: Health-related Quality of Life Among Patients Amputated Due to Peripheral Arterial Disease
A prospective cohort study over the prosthetic use among patients amputated after vascular disease and the impact of their HRQoL.
- Being tested
- Amputation
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmputationProcedure or surgery
Major amputation defined as at or above ankle
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health related quality of life according to EQ-5D
The change in HRQoL between baseline and after 1 year. Measured with EQ-5D-3L
Measured: 1 year
Secondary outcomes (1)
Proportion of patients using prosthesis
Prosthesis use after a major amputation is measured with Stanmore mobility grade
Measured: 1 year after the amputation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start12 Sep 2014
- Primary completion20 May 2019
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonas Malmstedt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonas Malmstedt, Karolinska Institutet
- Investigators
- Eva Torbjörnsson, Principal investigator, Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570788
- Sponsor's protocol ID
- 2014/801-31/1
- Status last verified
- Jun 2019
- First submitted
- 13 Jun 2018
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life Among Patients Amputated Due to Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT03570788
- Acronym / sponsor ID
- 2014/801-31/1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Jonas MalmstedtUniversity, hospital or other
- Study start
- 12 Sep 2014 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 27 Jun 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.
A prospective cohort study over the prosthetic use among patients amputated after vascular disease and the impact of their HRQoL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients amputated at Södersjukhuset during 2014-2018 are reviewed based on criteria for inclusion and exclusion. All patients that meets the inclusion criteria during the period will be contacted by the researcher in connection with the amputation and informed about the study.
Key inclusion criteria (1 listed)
- Patients amputated at femoral, knee or tibial level due to peripheral arterial disease
Key exclusion criteria (3 listed)
- Patients not able to provide informed consent
- Patients not able to verbally express their experience of the amputation.
- Patients that not speak Swedish
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 |
|---|---|---|
| AmputationMajor amputation defined as at or above ankle | Procedure or surgery | – |
Primary outcome
Change in Health related quality of life according to EQ-5D
Time frame: 1 year
The change in HRQoL between baseline and after 1 year. Measured with EQ-5D-3L
1 secondary outcome
Proportion of patients using prosthesis
Time frame: 1 year after the amputation
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 28 Jun 2019.
- 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.
Eva Torbjörnsson principal investigator
Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Amputation, run by Jonas Malmstedt at 1 site in Sweden.
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: finished, as of the sponsor's last update on 28 Jun 2019. 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 Sweden. 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 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?
Change in Health related quality of life according to EQ-5D (time frame: 1 year). 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 28 Jun 2019.