Lymphedema PrimaryPrimary LENCT07866599
Inelastic Compression Use in Primary Lymphedema
A study testing Compression device with medium pressure (23-32 mmHg) in people with Lymphedema Primary, run by University School of Physical Education, Krakow, Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- Lymphedema Primary
- What is being tested?
- Compression device with medium pressure (23-32 mmHg)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Mar 2027
- Phase
- Interventional
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 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- primary lymphedema in adults, age ≤ 26
- secondary lymphedema
- heart and kidney diseases
About this study
Official title: Efficacy, Adherence and Safety of Inelastic Compression Use in Children and Young People With Primary Lymphedema
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.
- Conditions
- Lymphedema Primary
- Being tested
- Compression device with medium pressure (23-32 mmHg)
- Keywords
- compression therapy, compression garment, physical activity, primary lymphedema, compliance, interface pressure under compression
- Medical subject headings
- Lymphedema, Motor Activity, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression device with medium pressure (23-32 mmHg)Device
Compression garment use with medium pressure during a day
| Study group | Role | What they receive |
|---|---|---|
| I Group Children (under 12 years of age) | Experimental | Inelastic (flat knit) compression garment with medium pressure (23-32 mmHg) Receives: Device: Compression device with medium pressure (23-32 mmHg) |
| II Group Young People (age 12-25 years) | Experimental | Inelastic (flat knit) compression garment with medium pressure (23-32 mmHg) Receives: Device: Compression device with medium pressure (23-32 mmHg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From enrollment to the end of treatment at 3 months
Body mass
weight in kg
Measured: From enrollment to the end of treatment at 3 months
Height
height in meters
Measured: 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).
Measured: 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)
Measured: 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)
Measured: During first and after 3 months of compression use
Secondary outcomes (5)
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
Measured: 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')
Measured: 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'
Measured: 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)
Measured: 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')
Measured: During the first and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema PrimaryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparison physiotherapeutic intervention based on compression therapy in children and young people
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866599
- Sponsor's protocol ID
- 37/RID/2026
- Other IDs
- 37/RID/2026
- Acronym
- Primary LE
- Status last verified
- Jul 2026
- First submitted
- 21 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided