An interventional study of Compression device with medium pressure (23-32 mmHg) in Lymphedema Primary, sponsored by University School of Physical Education, Krakow, Poland. Not yet recruiting. Open to participants aged 1 Year to 25 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University School of Physical Education, Krakow, Poland · Not applicable, Interventional, and Treatment
Primary lymphedema in children is a rare, chronic condition caused by congenital or inherited developmental abnormalities in the lymphatic system that lead to persistent fluid buildup and swelling. While there is no cure, early and regular intervention helps control swelling and allows children to lead active lives. While compression therapy (multilayer compression bandaging and compression garment use) is a standard of lymphedema treatment for adults clinical trials evaluating compression therapy specifically for children with primary lymphedema are severely limited. Management algorithms are heavily adopted from adults secondary lymphedema protocols. However the results obtained from clinical trials in adults cannot be directly extrapolated to children with primary lymphedema. Inelastic, short-stretch materials-is highly effective for treating children with primary lymphedema, but requires precise clinical caution to protect fragile pediatric skin. Dose-finding to establish safe and effective interface pressure threshold (measured in mmHg) appropriate for different age cohorts (e.g., infants under 2 years old, toddlers, and adolescents) is needed. Objective of the study is to assess efficacy, physical functioning, safety and adherence to compression therapy based on individually adapted (made to measure, MTM) compression garments (flat knit compression stockings) with medium pressure (23-32 mmHg, ccl2) in children and young adults with primary lymphedema during one and three months of maintenance therapy. The aim of this study is also verification if pressure and stiffness measured in vivo correlate with laboratory findings (compression garment in ccl2 delivered by manufacture) and whether there is a relationship between interface pressures under compression and limb volume measurements in children and young people. The compression garments will be selected individually on the basis of circumference measurements, taking during morning hours with detailed information how long to wear them (i.e. for about 10 hours each day) and will come from the same producer (Medi GmbH \& Co. Bayreuth, Germany). All physical activities are recommended while wearing compression garments.
561 studies on the registry are indexed under Lymphedema; 136 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 404 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →University School of Physical Education, Krakow, Poland is the lead sponsor of 21 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Inelastic (flat knit) compression garment with medium pressure (23-32 mmHg)
Device: Compression device with medium pressure (23-32 mmHg)
Inelastic (flat knit) compression garment with medium pressure (23-32 mmHg)
Device: Compression device with medium pressure (23-32 mmHg)
Compression garment use with medium pressure during a day
Limb volume measurement
Assessement including limb volumes based on the circumferential measurements by a tape (every 4 cm proximal along both limbs) will be performed (3 times) before the intervention, and after one and three months in both groups. Calculation of limb segment volumes was carried out using a simplified frustum formula (summed truncated cone). The excess volume is the difference between the affected and unaffected limbs expressed in litres.
Time frame: From enrollment to the end of treatment at 3 months
The percentage reduction of the excess volume
The percentage reduction of the excess volume will be obtained as follows: (excess volume before treatment - excess volume after treatment) x 100/excess volume before treatment
Time frame: From enrollment to the end of treatment at 3 months
Body mass
weight in kg
Time frame: From enrollment to the end of treatment at 3 months
Height
height in meters
Time frame: From enrollment to the end of treatment at 3 months
Body mass index
Weight and height will be combined to report BMI in kg/m\^2).
Time frame: From enrollment to the end of treatment at 3 months
WAC formula (weight-adjusted volume change )
WAC formula (weight-adjusted volume change) a parameter that accounts for body weight fluctuations, calculated as: WAC = (A2BMI1/BMI2A1) - 1, where A1 and A2 are limb volumes of the treated limb at baseline and after treatment, and BMI1 and BMI2 are Body Mass Indexes at the corresponding time points)
Time frame: From the first month to the end of treatment at 3 months
Interface pressure and stiffness index
Two types of pressure under compression expressed in mmHg will be measured: resting pressure and active pressure related to muscle pump. A stiffness index (difference between active and resting pressure) will be calculated. Interface pressure will be measured via the Kikuhime device (Kikgel, Ujazd, Poland)
Time frame: During first and after 3 months of compression use
Dosage of compression therapy
Children with the help of their parents (caregivers) according to the International Compression Club Compression Questionnaire (ICC-CQ) - Patient' version will evaluate how many hours during daytime, how many hours at night use the compression
Time frame: During the first and three months
Application and removing of compression
Children with the help of their parents (caregivers) according to the International Compression Club Compression Questionnaire (ICC-CQ) - Patient' version will evaluate garment application and removing difficulties: easy donning, easy doffing in 11-point Likert-type NRS scale - from 'not able at all' to 'completely able')
Time frame: During the first and three months
Physical functioning in relation to compression therapy
Children with the help of their parents (caregivers) according to the International Compression Club Compression Questionnaire (ICC-CQ) - Patient' version will evaluate physical functioning in relation to compression: ability to move the limbs and walk in 11-point Likert-type scale - from 'not able at all' to 'completely able'
Time frame: During the first and three months
Compression therapy and comfort
Children with the help of their parents (caregivers) according to the International Compression Club Compression Questionnaire (ICC-CQ) - Patient' version will evaluate comfort in compression: feeling immediately after donning, feeling during daytime, feeling at night, putting clothes on compression garments, and the appearance of the garment (measured on an 11-point Likert-type scale)
Time frame: During the first and three months
Safety of compression therapy
Children with the help of their parents (caregivers) according to the International Compression Club Compression Questionnaire (ICC-CQ) - Patient' version will evaluate complications of compression: skin irritation, tender spots, skin damage, itching, warmth, throbbing, cramps, cutting in, slippage, local swelling, bulky feeling, too tight feeling in 11-point Likert-type scale - from 'not at all' to 'a lot')
Time frame: During the first and three months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University School of Physical Education, Krakow, Poland