AmputeesNCT02445170
Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users
An observational study of Amputees and Diabetes Complications, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The present study assesses the health-related quality of life of diabetic transmetatarstal and below-knee prosthetic user. The study design is cross-sectional with a retrospective review of patient hospital records and an assessment with patient-reported outcome measure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputees, Diabetes Complications
- What is being tested?
- Amputation
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- Jul 2015to Dec 2015
- 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: Diabetic patients who underwent transmetatarsal amputaion or below-knee prosthetic users in a time frame of 2-5 years from the amputation.
Who may be able to join
- Patients with diabetes
- Transmetatarsal amputation
- Below-knee prosthetic user
- 2-5 years from surgery
Who cannot join
- No diabetes
- Other than transmetatarsal or below-knee amputation
- Below-knee amputation but not a below-knee prosthetic user
- Less than 2 years from the amputation
- Over 5 years from amputation
Trial locations and contacts
1 site in 1 country.
About this study
The present study assesses the health-related quality of life of diabetic transmetatarstal and below-knee prosthetic user. The study design is cross-sectional with a retrospective review of patient hospital records and an assessment with patient-reported outcome measure.
Read the detailed description
The present study aims to recruit 100 diabetic transmetatarsal and below-knee prosthetic user to assess the health-related quality of life (HRQoL) between these two patient groups. The 15D HRQoL instrument is applied. An additional comparison with the age-standardized Finnish general population will be performed.
- Conditions
- Amputees, Diabetes Complications
- Being tested
- Amputation
- Keywords
- Diabetes, amputation, below-knee, transmetatarsal, [M01.150.100], [C19.246.099]
- Medical subject headings
- Diabetes Complications, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmputationProcedure or surgery
Transmetatarsal or below-knee amputation
| Study group | Role | What they receive |
|---|---|---|
| Below-knee amputees | The present group consists of diabetic below-knee prosthetic user Receives: Procedure: Amputation | |
| Transmetatarsal amputees | The present group consists of diabetic transmetatarsal amputees Receives: Procedure: Amputation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life measured by the HRQoL score
Measured: 2-5 years
Secondary outcomes (1)
The 15D health-related quality of life instrument
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: The study is not eligible at present.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputeesStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jussi Repo, Helsinki University Central Hospital
- Investigators
- Erkki J Tukiainen, professor, Study director, Helsinki University Hospital and Helsinki University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445170
- Sponsor's protocol ID
- 364/13/03/02/2014/8
- Status last verified
- Aug 2016
- First submitted
- 8 May 2015
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users
- ClinicalTrials.gov ID
- NCT02445170
- Acronym / sponsor ID
- 364/13/03/02/2014/8
- Conditions
- Amputees, Diabetes Complications
- Keywords
- Diabetes, amputation, below-knee, transmetatarsal, [M01.150.100], [C19.246.099]
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study is not eligible at present.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 15 May 2015 (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.
The present study assesses the health-related quality of life of diabetic transmetatarstal and below-knee prosthetic user. The study design is cross-sectional with a retrospective review of patient hospital records and an assessment with patient-reported outcome measure.
Detailed description
The present study aims to recruit 100 diabetic transmetatarsal and below-knee prosthetic user to assess the health-related quality of life (HRQoL) between these two patient groups. The 15D HRQoL instrument is applied. An additional comparison with the age-standardized Finnish general population will be performed.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Below-knee amputees | – | Procedure: AmputationThe present group consists of diabetic below-knee prosthetic user |
| Transmetatarsal amputees | – | Procedure: AmputationThe present group consists of diabetic transmetatarsal amputees |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients who underwent transmetatarsal amputaion or below-knee prosthetic users in a time frame of 2-5 years from the amputation.
Key inclusion criteria (4 listed)
- Patients with diabetes
- Transmetatarsal amputation
- Below-knee prosthetic user
- 2-5 years from surgery
Key exclusion criteria (5 listed)
- No diabetes
- Other than transmetatarsal or below-knee amputation
- Below-knee amputation but not a below-knee prosthetic user
- Less than 2 years from the amputation
- Over 5 years from amputation
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 |
|---|---|---|
| AmputationTransmetatarsal or below-knee amputation | Procedure or surgery | Below-knee amputees, Transmetatarsal amputees |
Primary outcome
Health-related quality of life measured by the HRQoL score
Time frame: 2-5 years
1 secondary outcome
The 15D health-related quality of life instrument
Time frame: 2-5 years
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 19 Aug 2016.
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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.
Erkki J Tukiainen, professor study director
Helsinki University Hospital and Helsinki University
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 Amputees and Diabetes Complications, run by Helsinki University Central Hospital at 1 site in Finland.
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 4 inclusion and 5 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 19 Aug 2016. 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 Finland. 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?
Health-related quality of life measured by the HRQoL score (time frame: 2-5 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 19 Aug 2016.