Peripheral Arterial DiseasePhase 4FM-S1NCT00855673
Intermittent Mechanical Compression For Peripheral Arterial Disease
A Phase 4 study testing Intermittent Mechanical Compression in people with Peripheral Arterial Disease, run by Hospital Universitario Getafe.
Trial summary
The study tests the use of a portable mechanical compression device (FM220, Flowmedic, USA) for the treatment of claudication and peripheral arterial disease. Major endpoints are improved exercise tolerance and relevant blood pressure ratios Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Intermittent Mechanical Compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Dec 2007
- Phase
- Phase 4
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable claudication with an absolute claudication distance >40 meters but <300
- resting ABI in the affected limb <0.8
Who cannot join
- presence of diabetes
About this study
The study tests the use of a portable mechanical compression device (FM220, Flowmedic, USA) for the treatment of claudication and peripheral arterial disease.
Major endpoints are improved exercise tolerance and relevant blood pressure ratios
- Conditions
- Peripheral Arterial Disease
- Being tested
- Intermittent Mechanical Compression, Control
- Keywords
- Claudication, Peripheral Arterial Disease, Intermittent Compression, Mechanical Compression, Flowmedic
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Mechanical CompressionDevice
FM220 device
ControlDrug
Standard medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Active group receiving intermittent compression Receives: Device: Intermittent Mechanical Compression |
| Control | Active comparator | Standard Medical Treatment Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise tolerance
Measured: 3 months
Secondary outcomes (1)
ankle-brachial index
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startJan 2001
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Investigators
- Joaquin DeHaro, MD, Principal investigator, Hospital Universitario Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855673
- Sponsor's protocol ID
- FM-S1
- Acronym
- FM-S1
- Status last verified
- Feb 2009
- First submitted
- 2 Mar 2009
- Last updated
- 4 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Mechanical Compression For Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT00855673
- Acronym / sponsor ID
- FM-S1 / FM-S1
- Conditions
- Peripheral Arterial Disease
- Keywords
- Claudication, Peripheral Arterial Disease, Intermittent Compression, Mechanical Compression, Flowmedic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Mar 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.
The study tests the use of a portable mechanical compression device (FM220, Flowmedic, USA) for the treatment of claudication and peripheral arterial disease.
Major endpoints are improved exercise tolerance and relevant blood pressure ratios
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: Intermittent Mechanical CompressionActive group receiving intermittent compression |
| Control | Active comparator | Drug: ControlStandard Medical Treatment |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable claudication with an absolute claudication distance >40 meters but <300
- resting ABI in the affected limb <0.8
Key exclusion criteria (1 listed)
- presence of diabetes
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 |
|---|---|---|
| Intermittent Mechanical CompressionFM220 device | Device | Active |
| ControlStandard medical treatment | Drug | Control |
Primary outcome
exercise tolerance
Time frame: 3 months
1 secondary outcome
ankle-brachial index
Time frame: 3 months
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 4 Mar 2009.
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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.
Joaquin DeHaro, MD principal investigator
Hospital Universitario Getafe
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intermittent Mechanical Compression in people with Peripheral Arterial Disease, run by Hospital Universitario Getafe.
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 2 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 4 Mar 2009. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
exercise tolerance (time frame: 3 months). 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 4 Mar 2009.