Vascular DiseasesPhase 2NCT00616668
Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees
A Phase 2 study testing Air- Limb in people with Vascular Diseases, run by Sheba Medical Center.
Trial summary
The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and the process of rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Air- Limb
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Dec 2005
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Transtibial amputees due to vascular diseases.
Who cannot join
- Bilateral amputation.
- Upper extremity can't bear weight.
- The sound leg can't bear weight.
- Amputee that needs Dialysis treatment.
- Cognitive impairment.
About this study
The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and the process of rehabilitation.
Read the detailed description
The method of immediate adjustment of a temporary Prosthesis has been developed in the past, aiming to reduce the healing time of the stump and the process of rehabilitation. According to this method, a temporary Prosthesis is being adjusted immediately after amputation, or during the first week after it. Rehabilitation starts with the patient's standing while partial weight bearing on the Prosthesis.
In spite of many experiments and trials to adopt this process of rehabilitation, it is not universally adopted, because of the bad adjustment and damages to the stump caused by the Plaster of Paris. At present, with the improvement of materials and research experiments are being renewed, to check the efficiency of the process, using the Air- Limb a temporary Prosthesis.
- Conditions
- Vascular Diseases
- Being tested
- Air- Limb
- Keywords
- Transtibial amputees due to vascular diseases.
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air- LimbDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis.
Measured: 1-4 month
The total duration of the rehabilitation process,from amputation until the end of the hospitalization, with the permanent prosthesis.
Measured: 2-6 month
Secondary outcomes (1)
The duration of stump healing and functional status of transtibial amputees.
Measured: 1-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJan 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Itzhak Siev- Ner, MD, Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616668
- Sponsor's protocol ID
- SHEBA-07-2718-AK-CTIL
- Status last verified
- Feb 2008
- First submitted
- 4 Feb 2008
- Last updated
- 15 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees
- ClinicalTrials.gov ID
- NCT00616668
- Acronym / sponsor ID
- SHEBA-07-2718-AK-CTIL
- Conditions
- Vascular Diseases
- Keywords
- Transtibial amputees due to vascular diseases.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2003
- Study completion
- Dec 2005 (actual)
- First posted
- 15 Feb 2008 (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 aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and the process of rehabilitation.
Detailed description
The method of immediate adjustment of a temporary Prosthesis has been developed in the past, aiming to reduce the healing time of the stump and the process of rehabilitation. According to this method, a temporary Prosthesis is being adjusted immediately after amputation, or during the first week after it. Rehabilitation starts with the patient's standing while partial weight bearing on the Prosthesis.
In spite of many experiments and trials to adopt this process of rehabilitation, it is not universally adopted, because of the bad adjustment and damages to the stump caused by the Plaster of Paris. At present, with the improvement of materials and research experiments are being renewed, to check the efficiency of the process, using the Air- Limb a temporary Prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Transtibial amputees due to vascular diseases.
Key exclusion criteria (5 listed)
- Bilateral amputation.
- Upper extremity can't bear weight.
- The sound leg can't bear weight.
- Amputee that needs Dialysis treatment.
- Cognitive impairment.
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 |
|---|---|---|
| Air- Limb | Device | – |
Primary outcome
The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis.
Time frame: 1-4 month
The total duration of the rehabilitation process,from amputation until the end of the hospitalization, with the permanent prosthesis.
Time frame: 2-6 month
1 secondary outcome
The duration of stump healing and functional status of transtibial amputees.
Time frame: 1-6 month
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 15 Feb 2008.
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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.
Itzhak Siev- Ner, MD study director
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Air- Limb in people with Vascular Diseases, run by Sheba Medical Center.
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 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: finished, as of the sponsor's last update on 15 Feb 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis. (time frame: 1-4 month). The study lists 2 primary outcomes in all. 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 15 Feb 2008.