Efficacy, Adherence and Safety of Inelastic Compression Use in Children and Young People With Primary Lymphedema
| Registry | NCT07866599, acronym Primary LE |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; non randomized, parallel, masking: none, treatment |
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| Enrollment | 30 (Estimated) |
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| Sponsor | University School of Physical Education, Krakow, Poland (Other) |
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| Conditions | Lymphedema Primary |
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| Interventions | Compression device with medium pressure (23-32 mmHg) (Device) |
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| Dates | start 2026-09-01 (estimated), primary completion 2026-11-01 (estimated), completion 2027-03-01 (estimated), first posted 2026-10-08, last updated 2026-10-08 |
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Related Papers Related Patents Related Grants Related Experts
All trials for Lymphedema Primary All trials of Compression device with medium pressure (23-32 mmHg)
-Summary
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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| I Group Children (under 12 years of age) | Experimental | Device: Compression device with medium pressure (23-32 mmHg) | Inelastic (flat knit) compression garment with medium pressure (23-32 mmHg) |
| II Group Young People (age 12-25 years) | Experimental | Device: Compression device with medium pressure (23-32 mmHg) | Inelastic (flat knit) compression garment with medium pressure (23-32 mmHg) |
- Compression device with medium pressure (23-32 mmHg) (Device): Compression garment use with medium pressure during a day
+Outcome measures
Primary outcomes
- Limb volume measurement [From enrollment to the end of treatment at 3 months]: 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.
- The percentage reduction of the excess volume [From enrollment to the end of treatment at 3 months]: 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
- Body mass [From enrollment to the end of treatment at 3 months]: weight in kg
- Height [From enrollment to the end of treatment at 3 months]: height in meters
- Body mass index [From enrollment to the end of treatment at 3 months]: Weight and height will be combined to report BMI in kg/m\^2).
- WAC formula (weight-adjusted volume change ) [From the first month to the end of treatment at 3 months]: 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)
- Interface pressure and stiffness index [During first and after 3 months of compression use]: 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)
Secondary outcomes
- Dosage of compression therapy [During the first and three months]: 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
- Application and removing of compression [During the first and three months]: 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')
- Physical functioning in relation to compression therapy [During the first and three months]: 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'
- Compression therapy and comfort [During the first and three months]: 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)
- Safety of compression therapy [During the first and three months]: 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')
+Eligibility
Sex: All, ages: 1 Year to 25 Years
Inclusion Criteria:
* children with recognised primary lymphedema of limbs
* age < 1 year and ≥ 25 year
* positive Stemmer's sign
* vascular malformation,
* no contraindications to compression use
* written consent
Exclusion Criteria:
* primary lymphedema in adults, age ≤ 26
* secondary lymphedema
* heart and kidney diseases