Primary Lower Limb LymphedemaNCT02234674
Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema
A study testing Current intensive CDP and intensive CDP where Stendo pulsating suit replaces pressotherapy in people with Primary Lower Limb Lymphedema and Secondary Lower Limb Lymphedema, run by Stendo at 1 site in France.
Trial summary
This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP). This study is a pilot controlled randomized study with two arms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Lower Limb Lymphedema, Secondary Lower Limb Lymphedema
- What is being tested?
- Current intensive CDP and intensive CDP where Stendo pulsating suit replaces pressotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Feb 2015
- Phase
- Interventional
- 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
Who may be able to join
- Patient with a primary or secondary lympedema clinically diagnosed (Stemmer Sign) of one or two legs.
- Patient with a lympedema stage II (persistent) or III according to the classification of the International Society of Lymphoedema (ISL)
- Patient aged 18 or more
Who cannot join
- Patient with a severe heart, kidney or liver failure,
- Patient with an advanced obstructive arterial disease
- Patient with a recent and progressive deep venous thrombosis
Trial locations and contacts
1 site in 1 country.
About this study
This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).
This study is a pilot controlled randomized study with two arms.
- Being tested
- Current intensive CDP, intensive CDP where Stendo pulsating suit replaces pressotherapy
- Keywords
- Pulsating suit, lymphedema, leg volume
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current intensive CDPOther
Standard Intensive CDP including
- manual lymph drainage,
- pressotherapy and
- bandaging
intensive CDP where Stendo pulsating suit replaces pressotherapyOther
The intervention consist to perform daily during 5 days an intensive CDP where pressotheray is replaced by Stndo pulsating suit sessions.
| Study group | Role | What they receive |
|---|---|---|
| Standard intensive CDP | Active comparator | This arm is the controlled group ; patients in that group will undergo a current practice performed in the lymphology unit. Receives: Other: Current intensive CDP |
| Stendo group | Experimental | This arm contitutes the group where the Stendo pulsating suit sessions are investigated in the frame of the CDP in replacement of the pressotherapy sessions. Receives: Other: intensive CDP where Stendo pulsating suit replaces pressotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of the most affected leg
Change in % of the volume of the most affected leg according to disk model method
Measured: baseline ; after 5 days intensive CDP
Secondary outcomes (1)
Quality of Life
36 health survey questionnaire (SF-36) and Visual Analogical Scale
Measured: baseline ; after 5 days intensive CDP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Lower Limb LymphedemaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stendo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234674
- Sponsor's protocol ID
- 2014-A00355-42
- Status last verified
- Sep 2014
- First submitted
- 4 Sep 2014
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deltombe T, Jamart J, Recloux S, Legrand C, Vandenbroeck N, Theys S, Hanson P. Reliability and limits of agreement of circumferential, water displacement, and optoelectronic volumetry in the measurement of upper limb lymphedema. Lymphology. 2007 Mar;40(1):26-34.
PubMed 17539462Mayrovitz HN, Macdonald J, Davey S, Olson K, Washington E. Measurement decisions for clinical assessment of limb volume changes in patients with bilateral and unilateral limb edema. Phys Ther. 2007 Oct;87(10):1362-8. doi: 10.2522/ptj.20060382. Epub 2007 Aug 7.
PubMed 17684090
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema
- ClinicalTrials.gov ID
- NCT02234674
- Acronym / sponsor ID
- 2014-A00355-42
- Keywords
- Pulsating suit, lymphedema, leg volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- StendoIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 9 Sep 2014 (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.
This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).
This study is a pilot controlled randomized study with two arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard intensive CDP | Active comparator | Other: Current intensive CDPThis arm is the controlled group ; patients in that group will undergo a current practice performed in the lymphology unit. |
| Stendo group | Experimental | Other: intensive CDP where Stendo pulsating suit replaces pressotherapyThis arm contitutes the group where the Stendo pulsating suit sessions are investigated in the frame of the CDP in replacement of the pressotherapy sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with a primary or secondary lympedema clinically diagnosed (Stemmer Sign) of one or two legs.
- Patient with a lympedema stage II (persistent) or III according to the classification of the International Society of Lymphoedema (ISL)
- Patient aged 18 or more
Key exclusion criteria (3 listed)
- Patient with a severe heart, kidney or liver failure,
- Patient with an advanced obstructive arterial disease
- Patient with a recent and progressive deep venous thrombosis
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 |
|---|---|---|
| Current intensive CDPStandard Intensive CDP including * manual lymph drainage, * pressotherapy and * bandaging | Other | Standard intensive CDP |
| intensive CDP where Stendo pulsating suit replaces pressotherapyThe intervention consist to perform daily during 5 days an intensive CDP where pressotheray is replaced by Stndo pulsating suit sessions. | Other | Stendo group |
Primary outcome
volume of the most affected leg
Time frame: baseline ; after 5 days intensive CDP
Change in % of the volume of the most affected leg according to disk model method
1 secondary outcome
Quality of Life
Time frame: baseline ; after 5 days intensive CDP
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 22 May 2015.
- Results publication: PubMed 17539462Deltombe T, Jamart J, Recloux S, Legrand C, Vandenbroeck N, Theys S, Hanson P. Reliability and limits of agreement of circumferential, water displacement, and optoelectronic volumetry in the measurement of upper limb lymphedema. Lymphology. 2007 Mar;40(1):26-34.
- Results publication: PubMed 17684090Mayrovitz HN, Macdonald J, Davey S, Olson K, Washington E. Measurement decisions for clinical assessment of limb volume changes in patients with bilateral and unilateral limb edema. Phys Ther. 2007 Oct;87(10):1362-8. doi: 10.2522/ptj.20060382. Epub 2007 Aug 7.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Current intensive CDP and intensive CDP where Stendo pulsating suit replaces pressotherapy in people with Primary Lower Limb Lymphedema and Secondary Lower Limb Lymphedema, run by Stendo at 1 site in France.
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 3 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 22 May 2015. 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 France. 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?
volume of the most affected leg (time frame: baseline ; after 5 days intensive CDP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02234674, which also lists 2 linked publications.
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 22 May 2015.