EdemaDSOPALNCT02473744
Oedematous Lower Limb Subcutaneous Drainage in Palliative Care
A study testing subcutaneous drainage in people with Edema, run by University Hospital, Limoges at 7 sites in France.
Trial summary
Background : Edema of lower extremities is a concern ranging from 19 % to 60% of palliative cancer patients. Lymphedema decreases mobility, induces pain, impacts daily activities, esthetic and behavior. Usual treatment is based on diuretics and physiotherapy but is often unsuccessful. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edema
- What is being tested?
- subcutaneous drainage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 7 sitesFrance
- Study dates
- 27 Jul 2015to 20 Jul 2017
- 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
- Age ≥ 18
- palliative care patients
- Karnofsky Scale < 50%
- Uni or bilateral lower limb oedema even if associated with lumbar or pelvi-scrotal oedema or ascitis whatever etiology involved (cancer, organ failure, hypoalbuminemia…)
- Effective Social security regimen affiliation
- Signed informed consent
Who cannot join
- Refusal to take part in the study
- Local anesthesic contraindication
- Infected skin lesions.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
University hospital
Bordeaux, 33000
University hospital
Limoges, 87042
University hospital
Nantes, 40031
Hospital
Périgueux, 24019
Joseph Ducuing hospital
Toulouse, 31027
University hospital
Toulouse, 31059
Hospital
Valenciennes, 59300
About this study
- Background : Edema of lower extremities is a concern ranging from 19 % to 60% of palliative cancer patients. Lymphedema decreases mobility, induces pain, impacts daily activities, esthetic and behavior. Usual treatment is based on diuretics and physiotherapy but is often unsuccessful. In case of conventional treatment failure, in palliative care, subcutaneous drainage can be discussed with the patients. The technique is simple, easy to use but remains off the record. Since 2004, 23 cases were reported with various methods. All the cases reported were undertaken with various technical approaches and efficacy criteria.
- Purpose : Investigator hypothesize that the subcutaneous drainage of edema (SDO) is effective in case of refractory lymphedema of the lower limbs in palliative care and leads to an improvement in QOL in terms of behavioral and autonomy.
Read the detailed description
- Abstract : In palliative care, lymphedema results from various associations of cancer, hypoalbuminemia, electrolytic disturbances or organ failure. The lymphatic circulation cannot be summarized by the Starling's equation and obstruction cannot explain everything. An interstitial hypothesis underlines the role of the lymphatic pump and edema volume can be a crucial point. The SDO, via the direct liquid removal, can restore the lymphatic pump function. This volumetric effect can explain the long time effect of the SDO and the large range of liquid amount reported in effective SDO. The superficial lymphatic system, in the superficial layer of derma, drains 80 % of lymph flow. In edema, the increased volume leads to the creation of subcutaneous interconnected lacunas. The subcutaneous site for drainage is justified.
After topic anesthesia, three subcutaneous channels are created on the ankle's medial face of the edematous limbs and liquids are absorbed by pads. An additional drainage can be done on the external face of the thigh with liquid collecting bags in bedridden patients.
The study includes clinical examination, total and segmental bioelectrical impedance measured at J0, J4 and on exit or at J7 at the latest and daily weight, umbilic abdominal perimeters and segmental circumferences and QOL evaluation before and after SDO. Bioelectrical impedance is collected from hand-foot, thigh root-foot and under patella calf - foot electrodes. Segmental circumferences are collected at thigh, calf and ankle points identified from bone relief distance.
- Conditions
- Edema
- Being tested
- subcutaneous drainage
- Keywords
- lower limb edema, subcutaneous drainage, bioelectrical impedance, quality of life
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous drainageOther
After topic analgesia, three subcutaneous channels are created and an absorbent pad collects the lymphatic fluid.
| Study group | Role | What they receive |
|---|---|---|
| Oedematous lower limb subcutaneous drainage | Experimental | In case of lymphoedema in palliative situation, a subcutaneous drainage can be performed. It is a simple method, easy to use. After topic analgesia, three subcutaneous channels are created and an absorbent pad collects the lymphatic fluid. Receives: Other: subcutaneous drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Karnofsky's scale
Change in autonomy evaluated by Karnofsky's scale between Day 7 and Day 0
Measured: 7 days
Secondary outcomes (8)
Karnofsky's scale
Change in autonomy evaluated by Karnofsky's scale between Day 4 and Day 0
Measured: 4 Days
The 15th item of the European Organisation for Research and Treatment of Cancer quality of life questionnaires of palliative cancer care patients (EORTC QLQ C15 PAL),
Changes in quality of life evaluated by the 15th item of the EORTC QLQ C15 PAL scale between between Day 4/Day 7 and Day 0
Measured: 4 days and 7 days
Modify Dermatology Life Quality Index (MDLQI)
Changes in quality of life related to lymphedema evaluated by the MDLQI between Day 4/Day 7 and Day 0
Measured: 4 days and 7 days
Verbal numeric scale for pain
Changes in pain evaluated by the verbal numeric scale between Day 4/Day 7 and Day 0
Measured: 4 days and 7 days
Bioelectrical impedance analysis of lower limbs, calves and thighs
Changes in bioelectrical impedance of lower limbs, calves and thighs between Day 4/Day 7 and Day 0.
Measured: 4 days and 7 days
Segmental limb circumferences measurement
Variation of the physical measures in time. Changes in segmental limb circumferences between Day 4/Day 7 and Day 0
Measured: 4 days and 7 days
Abdominal perimeter measurement
Variation of the physical measures in time. Changes in abdominal perimeter between Day 4/Day 7 and Day 0
Measured: 4 days and 7 days
Weight measurement
Variation of the physical measures in time. Changes in weight between Day 4/Day 7 and Day 0
Measured: 4 days and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study start27 Jul 2015
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Why it stopped: Not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdemaStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand SARDIN, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473744
- Sponsor's protocol ID
- I14010 DSOPAL
- Acronym
- DSOPAL
- Status last verified
- Nov 2017
- First submitted
- 8 Jun 2015
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oedematous Lower Limb Subcutaneous Drainage in Palliative Care
- ClinicalTrials.gov ID
- NCT02473744
- Acronym / sponsor ID
- DSOPAL / I14010 DSOPAL
- Conditions
- Edema
- Keywords
- lower limb edema, subcutaneous drainage, bioelectrical impedance, quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 27 Jul 2015 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 17 Jun 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.
- Background : Edema of lower extremities is a concern ranging from 19 % to 60% of palliative cancer patients. Lymphedema decreases mobility, induces pain, impacts daily activities, esthetic and behavior. Usual treatment is based on diuretics and physiotherapy but is often unsuccessful. In case of conventional treatment failure, in palliative care, subcutaneous drainage can be discussed with the patients. The technique is simple, easy to use but remains off the record. Since 2004, 23 cases were reported with various methods. All the cases reported were undertaken with various technical approaches and efficacy criteria.
- Purpose : Investigator hypothesize that the subcutaneous drainage of edema (SDO) is effective in case of refractory lymphedema of the lower limbs in palliative care and leads to an improvement in QOL in terms of behavioral and autonomy.
Detailed description
- Abstract : In palliative care, lymphedema results from various associations of cancer, hypoalbuminemia, electrolytic disturbances or organ failure. The lymphatic circulation cannot be summarized by the Starling's equation and obstruction cannot explain everything. An interstitial hypothesis underlines the role of the lymphatic pump and edema volume can be a crucial point. The SDO, via the direct liquid removal, can restore the lymphatic pump function. This volumetric effect can explain the long time effect of the SDO and the large range of liquid amount reported in effective SDO. The superficial lymphatic system, in the superficial layer of derma, drains 80 % of lymph flow. In edema, the increased volume leads to the creation of subcutaneous interconnected lacunas. The subcutaneous site for drainage is justified.
After topic anesthesia, three subcutaneous channels are created on the ankle's medial face of the edematous limbs and liquids are absorbed by pads. An additional drainage can be done on the external face of the thigh with liquid collecting bags in bedridden patients.
The study includes clinical examination, total and segmental bioelectrical impedance measured at J0, J4 and on exit or at J7 at the latest and daily weight, umbilic abdominal perimeters and segmental circumferences and QOL evaluation before and after SDO. Bioelectrical impedance is collected from hand-foot, thigh root-foot and under patella calf - foot electrodes. Segmental circumferences are collected at thigh, calf and ankle points identified from bone relief distance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oedematous lower limb subcutaneous drainage | Experimental | Other: subcutaneous drainageIn case of lymphoedema in palliative situation, a subcutaneous drainage can be performed. It is a simple method, easy to use. After topic analgesia, three subcutaneous channels are created and an absorbent pad collects the lymphatic fluid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18
- palliative care patients
- Karnofsky Scale < 50%
- Uni or bilateral lower limb oedema even if associated with lumbar or pelvi-scrotal oedema or ascitis whatever etiology involved (cancer, organ failure, hypoalbuminemia…)
- Effective Social security regimen affiliation
Key exclusion criteria (3 listed)
- Refusal to take part in the study
- Local anesthesic contraindication
- Infected skin lesions.
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 |
|---|---|---|
| subcutaneous drainageAfter topic analgesia, three subcutaneous channels are created and an absorbent pad collects the lymphatic fluid. | Other | Oedematous lower limb subcutaneous drainage |
Primary outcome
Karnofsky's scale
Time frame: 7 days
Change in autonomy evaluated by Karnofsky's scale between Day 7 and Day 0
8 secondary outcomes
Karnofsky's scale
Time frame: 4 Days
The 15th item of the European Organisation for Research and Treatment of Cancer quality of life questionnaires of palliative cancer care patients (EORTC QLQ C15 PAL),
Time frame: 4 days and 7 days
Modify Dermatology Life Quality Index (MDLQI)
Time frame: 4 days and 7 days
Verbal numeric scale for pain
Time frame: 4 days and 7 days
Bioelectrical impedance analysis of lower limbs, calves and thighs
Time frame: 4 days and 7 days
Segmental limb circumferences measurement
Time frame: 4 days and 7 days
Abdominal perimeter measurement
Time frame: 4 days and 7 days
Weight measurement
Time frame: 4 days and 7 days
Results and safety
The study was stopped early (reason given: Not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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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.
Bertrand SARDIN, MD principal investigator
University Hospital, Limoges
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcutaneous drainage in people with Edema, run by University Hospital, Limoges at 7 sites 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 6 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: stopped early, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 was stopped early (reason given: Not enough patients). Results are not available in the source record.
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?
Karnofsky's scale (time frame: 7 days). 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 14 Nov 2017.