Lymphedema of LegNCT05970068
Hydrophobic Tubes for the Treament of Lower and Upper Limb Lymphedema
A study testing implantation of hydrophobic tubes for edema fluid drainage and Best Medical Treatment in people with Lymphedema of Leg, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Lymphedema is a chronic condition causing fluid buildup in affected limbs. Traditional treatments often fall short, but subcutaneous implantation of hydrophobic silicone tubes shows promise, creating artificial drainage pathways. This approach proved effective in managing obstructive lymphedema in lower limbs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphedema of Leg
- What is being tested?
- implantation of hydrophobic tubes for edema fluid drainage and Best Medical Treatment
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Dec 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lower limb lymphedema (Grade II-IV)
- Total occlusion at lymphoscintigraphy
- Patients treated at Centro Hospitalar Universitário de São João by the same surgical team
- Age >18 years old;
- Lymphedema praecox
- Lower limb perimeter >15% superior to contralateral limb
Who cannot join
- Secondary lymphedema
- Congenital lymphedema (Milroy, Meige, Klinefelter, Noonan, and Turner syndromes)
- Acute infection of the limb
- Chronic venous insufficiency
- Neoplasic disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Faculdade de Medicina da Universidade do Porto
Porto, 4200-319
About this study
Official title: Implantation of Hydrophobic Tubes for Edema Fluid Drainage in Obstructive Lymphedema of Limbs - a Randomized Clinical Trial
Lymphedema is a chronic condition causing fluid buildup in affected limbs. Traditional treatments often fall short, but subcutaneous implantation of hydrophobic silicone tubes shows promise, creating artificial drainage pathways. This approach proved effective in managing obstructive lymphedema in lower limbs. Further research is needed to validate its efficacy and explore long-term outcomes.
Read the detailed description
Lymphedema is a chronic condition that affects the lymphatic system and accumulates protein-rich fluid in the interstitial spaces of the affected limb. The condition can occur after surgery, trauma, radiation therapy, or infection and can cause significant physical, functional, and psychosocial impairment. The chronic swelling and fibrosis of the affected limb can lead to difficulty with daily activities, decreased mobility, reduced quality of life, and increased susceptibility to infections (1).
Currently, the management of lymphedema involves both conservative and surgical approaches. Conservative treatment includes complex decongestive therapy, which combines manual lymphatic drainage, compression therapy, exercise, and skincare (reference here). While this approach can be effective, it requires long-term commitment and compliance from patients, which can be challenging (reference here). Surgical approaches, such as lymphaticovenular anastomosis or vascularized lymph node transfer, are reserved for patients with mild to severe or refractory lymphedema with moderate results (2).
Liposuction has been used as a treatment for lower limb lymphedema. The traditional treatment of lymphedema includes compression garments, exercise, and manual lymphatic drainage, but these methods are not very effective.
In advanced cases of lymphedema, where all main lymphatics vessels are obstructed, one possible solution may be to create artificial pathways for edema fluid to flow away from the obstructed regions. This can be achieved through the subcutaneous implantation of silicone tubes, a novel method for draining edema fluid in obstructive lymphedema of limbs (3).
In the lower limbs, the tubes are placed from the leg to the lumbar or hypogastric region, creating channels for fluid to flow away from the obstructed areas to the non-obstructed regions, where absorption can take place.
The subcutaneous implantation of hydrophobic tubes is a minimally invasive procedure that has shown promising results in the management of obstructive lymphedema of the lower limbs.
In a group of 20 patients with obstructive lymphedema of the lower limbs that developed after lymphadenectomy and irradiation of the pelvis because of uterine cancer, this procedure was found to be effective after unsuccessful conservative therapy. The patients underwent the implantation of hydrophobic silicone tubes, followed by external compression using intermittent pneumatic compression and elastic support of tissues (3).
Overall, the implantation of hydrophobic tubes presents a promising alternative for managing obstructive lymphedema of the lower limbs. It has the potential to improve the quality of life for those who suffer from this condition, especially in advanced cases where other treatment options have failed. Further research is necessary to validate the efficacy of this approach and its long-term outcomes as well as to develop new bioengineered tubes for the drainage of lymphedematous extremities.
- Vaillant L, Tauveron V. [Primary lymphedema of limbs]. Presse Med. 2010;39(12):1279-86.
- Lee JW, Lee TY, Moon KC, You HJ, Kim DW. Lymphatic complex transfer as combined lymph vessel and node transfer for advanced stage upper extremity lymphedema. J Vasc Surg Venous Lymphat Disord. 2023.
- Olszewski WL, Zaleska M. A novel method of edema fluid drainage in obstructive lymphedema of limbs by implantation of hydrophobic silicone tubes. J Vasc Surg Venous Lymphat Disord. 2015;3(4):401-8.
- Kwon HR, Hwang JH, Mun GH, Hyun SH, Moon SH, Lee KH, et al. Predictive role of lymphoscintigraphy undergoing lymphovenous anastomosis in patients with lower extremity lymphedema: a preliminary study. BMC Med Imaging. 2021;21(1):188.
- Nuri T, Iwanaga H, Otsuki Y, Ueda K. Lymphoscintigraphy for prediction of effect of lymphaticovenular anastomosis for treatment of secondary lower limb lymphedema. J Vasc Surg Venous Lymphat Disord. 2022;10(5):1079-86 e2.
- Conditions
- Lymphedema of Leg
- Being tested
- implantation of hydrophobic tubes for edema fluid drainage, Best Medical Treatment
- Keywords
- Lymphedema, quality of life, edema, lower limb
- Medical subject headings
- Lymphedema, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantation of hydrophobic tubes for edema fluid drainageProcedure or surgery
1 - A 2-cm-long incision is made at the border of the hypogastrium or lumbar region 10 cm above the inguinal crease; 2- A 1.5-cm-wide and 100-cm-long metal tube tunneling device is introduced under the skin and bluntly passed in the subcutaneous tissue toward the thigh and internal aspect of the calf; 3- Incisions 2 cm long are made in the groin and calf, through which the tunneling device was passed; 4-The hydrophobic tube is passed upward through the tunneling device, after which the tunneling device is removed; 5-The upper and lower ends of the hydrophobic tubes are fixed to the fascia with absorbable sutures.
Best Medical TreatmentDevice
Compressive therapy, Phisioterapy, venous intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Surgery + best medical treatment | Experimental | The intervention group would receive the novel treatment of implantation of hydrophobic tubes for edema fluid drainage and the best medical treatment available. Receives: Procedure: implantation of hydrophobic tubes for edema fluid drainage; Device: Best Medical Treatment |
| Group 2: best medical treatment | Active comparator | This control group would receive only the best medical treatment available. Receives: Device: Best Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limb circumference in cm
Lower limb circumference in cm - ankle, calf 15 cm below the knee; knee; thigh 15 cm above the knee
Measured: Preoperative, six months, one year, second year
Secondary outcomes (3)
PROMS - Lymphedema quality of life
diseae specific qol questionnaire
Measured: preoperative, six months, one year, two years
PROMS - SF 36
Qol questionnaire
Measured: preoperative, six months, one year, two years
Lymphoscintigraphy
diagnostic exam
Measured: preoperative, one year (only in the intervention group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start15 Dec 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
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 Lymphedema of LegStudies 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
- Model description
- Once eligible patients have been identified, they would be randomized into one of two groups - the intervention group or the control group. Randomization will help ensure that the two groups are comparable in terms of baseline characteristics, which can minimize the risk of bias in the study. The program used will be https://www.random.org/lists/. Group 1: Surgery + best medical treatment The intervention group would receive the novel treatment of implantation of hydrophobic tubes for edema fluid drainage, in addition to the best medical treatment available. Group 2: best medical treatment This control group would receive only the best medical treatment available.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Rocha Neves, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970068
- Sponsor's protocol ID
- 300-23
- Status last verified
- Oct 2023
- First submitted
- 23 Jul 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only principal Investigators
Publications
Olszewski WL, Zaleska M. A novel method of edema fluid drainage in obstructive lymphedema of limbs by implantation of hydrophobic silicone tubes. J Vasc Surg Venous Lymphat Disord. 2015 Oct;3(4):401-408. doi: 10.1016/j.jvsv.2015.05.001. Epub 2015 Jun 30.
PubMed 26992618Kwon HR, Hwang JH, Mun GH, Hyun SH, Moon SH, Lee KH, Choi JY. Predictive role of lymphoscintigraphy undergoing lymphovenous anastomosis in patients with lower extremity lymphedema: a preliminary study. BMC Med Imaging. 2021 Dec 8;21(1):188. doi: 10.1186/s12880-021-00713-1.
PubMed 34879819
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of Hydrophobic Tubes for Edema Fluid Drainage in Obstructive Lymphedema of Limbs - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05970068
- Acronym / sponsor ID
- 300-23
- Conditions
- Lymphedema of Leg
- Keywords
- Lymphedema, quality of life, edema, lower limb
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Aug 2023 (actual)
- 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.
Lymphedema is a chronic condition causing fluid buildup in affected limbs. Traditional treatments often fall short, but subcutaneous implantation of hydrophobic silicone tubes shows promise, creating artificial drainage pathways. This approach proved effective in managing obstructive lymphedema in lower limbs. Further research is needed to validate its efficacy and explore long-term outcomes.
Detailed description
Lymphedema is a chronic condition that affects the lymphatic system and accumulates protein-rich fluid in the interstitial spaces of the affected limb. The condition can occur after surgery, trauma, radiation therapy, or infection and can cause significant physical, functional, and psychosocial impairment. The chronic swelling and fibrosis of the affected limb can lead to difficulty with daily activities, decreased mobility, reduced quality of life, and increased susceptibility to infections (1).
Currently, the management of lymphedema involves both conservative and surgical approaches. Conservative treatment includes complex decongestive therapy, which combines manual lymphatic drainage, compression therapy, exercise, and skincare (reference here). While this approach can be effective, it requires long-term commitment and compliance from patients, which can be challenging (reference here). Surgical approaches, such as lymphaticovenular anastomosis or vascularized lymph node transfer, are reserved for patients with mild to severe or refractory lymphedema with moderate results (2).
Liposuction has been used as a treatment for lower limb lymphedema. The traditional treatment of lymphedema includes compression garments, exercise, and manual lymphatic drainage, but these methods are not very effective.
In advanced cases of lymphedema, where all main lymphatics vessels are obstructed, one possible solution may be to create artificial pathways for edema fluid to flow away from the obstructed regions. This can be achieved through the subcutaneous implantation of silicone tubes, a novel method for draining edema fluid in obstructive lymphedema of limbs (3).
In the lower limbs, the tubes are placed from the leg to the lumbar or hypogastric region, creating channels for fluid to flow away from the obstructed areas to the non-obstructed regions, where absorption can take place.
The subcutaneous implantation of hydrophobic tubes is a minimally invasive procedure that has shown promising results in the management of obstructive lymphedema of the lower limbs.
In a group of 20 patients with obstructive lymphedema of the lower limbs that developed after lymphadenectomy and irradiation of the pelvis because of uterine cancer, this procedure was found to be effective after unsuccessful conservative therapy. The patients underwent the implantation of hydrophobic silicone tubes, followed by external compression using intermittent pneumatic compression and elastic support of tissues (3).
Overall, the implantation of hydrophobic tubes presents a promising alternative for managing obstructive lymphedema of the lower limbs. It has the potential to improve the quality of life for those who suffer from this condition, especially in advanced cases where other treatment options have failed. Further research is necessary to validate the efficacy of this approach and its long-term outcomes as well as to develop new bioengineered tubes for the drainage of lymphedematous extremities.
- Vaillant L, Tauveron V. [Primary lymphedema of limbs]. Presse Med. 2010;39(12):1279-86.
- Lee JW, Lee TY, Moon KC, You HJ, Kim DW. Lymphatic complex transfer as combined lymph vessel and node transfer for advanced stage upper extremity lymphedema. J Vasc Surg Venous Lymphat Disord. 2023.
- Olszewski WL, Zaleska M. A novel method of edema fluid drainage in obstructive lymphedema of limbs by implantation of hydrophobic silicone tubes. J Vasc Surg Venous Lymphat Disord. 2015;3(4):401-8.
- Kwon HR, Hwang JH, Mun GH, Hyun SH, Moon SH, Lee KH, et al. Predictive role of lymphoscintigraphy undergoing lymphovenous anastomosis in patients with lower extremity lymphedema: a preliminary study. BMC Med Imaging. 2021;21(1):188.
- Nuri T, Iwanaga H, Otsuki Y, Ueda K. Lymphoscintigraphy for prediction of effect of lymphaticovenular anastomosis for treatment of secondary lower limb lymphedema. J Vasc Surg Venous Lymphat Disord. 2022;10(5):1079-86 e2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Once eligible patients have been identified, they would be randomized into one of two groups - the intervention group or the control group. Randomization will help ensure that the two groups are comparable in terms of baseline characteristics, which can minimize the risk of bias in the study. The program used will be https://www.random.org/lists/. Group 1: Surgery + best medical treatment The intervention group would receive the novel treatment of implantation of hydrophobic tubes for edema fluid drainage, in addition to the best medical treatment available. Group 2: best medical treatment This control group would receive only the best medical treatment available.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Surgery + best medical treatment | Experimental | Procedure: implantation of hydrophobic tubes for edema fluid drainage, Device: Best Medical TreatmentThe intervention group would receive the novel treatment of implantation of hydrophobic tubes for edema fluid drainage and the best medical treatment available. |
| Group 2: best medical treatment | Active comparator | Device: Best Medical TreatmentThis control group would receive only the best medical treatment available. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Lower limb lymphedema (Grade II-IV)
- Total occlusion at lymphoscintigraphy
- Patients treated at Centro Hospitalar Universitário de São João by the same surgical team
- Age >18 years old;
- Lymphedema praecox
Key exclusion criteria (5 listed)
- Secondary lymphedema
- Congenital lymphedema (Milroy, Meige, Klinefelter, Noonan, and Turner syndromes)
- Acute infection of the limb
- Chronic venous insufficiency
- Neoplasic disease
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 |
|---|---|---|
| implantation of hydrophobic tubes for edema fluid drainage1 - A 2-cm-long incision is made at the border of the hypogastrium or lumbar region 10 cm above the inguinal crease; 2- A 1.5-cm-wide and 100-cm-long metal tube tunneling device is introduced under the skin and bluntly passed in the subcutaneous tissue toward the thigh and internal aspect of the calf; 3- Incisions 2 cm long are made in the groin and calf, through which the tunneling device was passed; 4-The hydrophobic tube is passed upward through the tunneling device, after which the tunneling device is removed; 5-The upper and lower ends of the hydrophobic tubes are fixed to the fascia with absorbable sutures. | Procedure or surgery | Group 1: Surgery + best medical treatment |
| Best Medical TreatmentCompressive therapy, Phisioterapy, venous intervention | Device | Group 1: Surgery + best medical treatment, Group 2: best medical treatment |
Primary outcome
Lower limb circumference in cm
Time frame: Preoperative, six months, one year, second year
Lower limb circumference in cm - ankle, calf 15 cm below the knee; knee; thigh 15 cm above the knee
3 secondary outcomes
PROMS - Lymphedema quality of life
Time frame: preoperative, six months, one year, two years
PROMS - SF 36
Time frame: preoperative, six months, one year, two years
Lymphoscintigraphy
Time frame: preoperative, one year (only in the intervention group)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Background: PubMed 26992618Olszewski WL, Zaleska M. A novel method of edema fluid drainage in obstructive lymphedema of limbs by implantation of hydrophobic silicone tubes. J Vasc Surg Venous Lymphat Disord. 2015 Oct;3(4):401-408. doi: 10.1016/j.jvsv.2015.05.001. Epub 2015 Jun 30.
- Background: PubMed 34879819Kwon HR, Hwang JH, Mun GH, Hyun SH, Moon SH, Lee KH, Choi JY. Predictive role of lymphoscintigraphy undergoing lymphovenous anastomosis in patients with lower extremity lymphedema: a preliminary study. BMC Med Imaging. 2021 Dec 8;21(1):188. doi: 10.1186/s12880-021-00713-1.
- Individual participant dataSharing planned: No. only principal Investigators
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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.
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 implantation of hydrophobic tubes for edema fluid drainage and Best Medical Treatment in people with Lymphedema of Leg, run by Universidade do Porto at 1 site in Portugal.
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 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: opening soon, as of the sponsor's last update on 1 Nov 2023. 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
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?
Lower limb circumference in cm (time frame: Preoperative, six months, one year, second year). 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 NCT05970068, 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 1 Nov 2023.