Health TrialsbyHealthPanel

Hydrophobic Tubes for the Treament of Lower and Upper Limb Lymphedema

ConditionLymphedema of Leg
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversidade do Porto

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Secondary lymphedema

Congenital lymphedema (Milroy, Meige, Klinefelter, Noonan, and Turner syndromes)

Acute infection of the limb

Chronic venous insufficiency

Trial design

Design model

Parallel

Treatments tested in this trial

  • implantation of hydrophobic tubes for edema fluid drainage

    Procedure/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 Treatment

    Device

    Compressive therapy, Phisioterapy, venous intervention

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Group 1: Surgery + best medical treatmentExperimental treatment 2 interventions
Group B: Group 2: best medical treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Lower limb circumference in cm

Lower limb circumference in cm - ankle, calf 15 cm below the knee; knee; thigh 15 cm above the knee

Time frame
Preoperative, six months, one year, second year

Secondary outcomes

1

PROMS - Lymphedema quality of life

diseae specific qol questionnaire

Time frame
preoperative, six months, one year, two years
2

PROMS - SF 36

Qol questionnaire

Time frame
preoperative, six months, one year, two years
3

Lymphoscintigraphy

diagnostic exam

Time frame
preoperative, one year (only in the intervention group)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade do Porto

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: