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Clinical Trials in Portugal / NCT05970068
Starting soon Not applicable

Hydrophobic Tubes for the Treament of Lower and Upper Limb Lymphedema

NCT05970068 · tracked via the Priya Life Science Portugal tracker
Phase
Not applicable
Started
2023-12-15
Last updated
2023-11-01

Condition(s) studied

Lymphedema of Leg

Investigational drug(s) / intervention(s)

implantation of hydrophobic tubes for edema fluid drainageBest Medical Treatment

implantation of hydrophobic tubes for edema fluid drainage: 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 Treatment: Compressive therapy, Phisioterapy, venous intervention

Study 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. Further research is needed to validate its efficacy and explore long-term outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Secondary lymphedema * Congenital lymphedema (Milroy, Meige, Klinefelter, Noonan, and Turner syndromes) * Acute infection of the limb * Chronic venous insufficiency * Neoplasic disease

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Faculdade de Medicina da Universidade do Porto Porto Portugal

More Universidade do Porto trials in Portugal

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05970068 on ClinicalTrials.gov ↗ ← All trials in Portugal