An observational study in Lymphedema of Lower Limb and Lymphedema, Secondary, sponsored by Kayseri City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Kayseri City Hospital · Observational
This prospective single-center study evaluated whether 4 weeks of phase-1 complex decongestive therapy (manual lymphatic drainage, multilayer short-stretch bandaging, decongestive exercise, and skin care) changes dermal and subcutaneous tissue thickness measured by high-frequency ultrasonography in adults with unilateral International Society of Lymphology stage 1-2 lower-limb lymphedema. Measurements were made at suprapatellar and infrapatellar sites of both limbs before and after treatment; the unaffected limb served as an internal control and body weight was recorded to distinguish local tissue change from systemic weight change.
Participants received a standardized 20-session (5 days/week, 4 weeks) intensive-phase complex decongestive therapy program delivered by an experienced physiotherapist. Ultrasonographic measurements were performed with a 10-14 MHz linear probe using a minimal-compression technique after 15 minutes of supine rest, at the same time of day, by an assessor blinded to baseline values; intra-rater reliability (intraclass correlation coefficient 0.92) was established in 10 patients. The sample size (n = 34; Cohen's d = 0.5, power 80%, alpha 0.05; 40 recruited) was calculated with G*Power. Paired comparisons (paired t-test or Wilcoxon signed-rank test), 95% confidence intervals, Cohen's d, and Pearson correlation of treatment response with age, body mass index, and disease duration were planned.
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's enrollment of 40 is below the median of 103 across 145 observational studies indexed under Lymphedema.
Browse Lymphedema studies →Kayseri City Hospital is the lead sponsor of 49 studies on the registry; 15 are open to participants now.
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Adults presenting to the Physical Medicine and Rehabilitation outpatient clinic of Kayseri City Hospital with unilateral lower-limb lymphedema and an indication for intensive-phase complex decongestive therapy.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with unilateral ISL stage 1-2 lower-limb lymphedema who received 4 weeks (20 sessions) of phase-1 complex decongestive therapy as standard care. Dermal and subcutaneous tissue thickness were measured by high-frequency ultrasonography at suprapatellar and infrapatellar sites of both limbs before and after treatment; the unaffected limb served as an internal control.
Other: Complex Decongestive Therapy
Phase-1 (intensive) complex decongestive therapy delivered 5 days per week for 4 weeks (20 sessions) by an experienced physiotherapist: Vodder-technique manual lymphatic drainage (30-45 min), multilayer short-stretch compression bandaging from the toes to the proximal thigh, decongestive range-of-motion exercise performed with bandages in place, and daily skin care with a pH 5.5 moisturizer.
Also known as: Complete Decongestive Therapy
Change in subcutaneous tissue thickness of the affected limb at the suprapatellar site
Subcutaneous tissue thickness (dermis-subcutis interface to deep fascia) measured in millimeters by B-mode ultrasonography with a 10-14 MHz linear probe using a minimal-compression technique.
Time frame: Baseline and end of week 4 (after 20 sessions of complex decongestive therapy)
Change in subcutaneous tissue thickness of the affected limb at the infrapatellar site
Subcutaneous tissue thickness in millimeters measured by B-mode ultrasonography (10-14 MHz linear probe, minimal-compression technique).
Time frame: Baseline and end of week 4
Change in dermal thickness of the affected limb at the suprapatellar and infrapatellar sites
Dermal thickness (skin surface to dermis-subcutis interface) in millimeters measured by B-mode ultrasonography.
Time frame: Baseline and end of week 4
Change in subcutaneous tissue thickness of the unaffected (control) limb
Subcutaneous tissue thickness of the contralateral unaffected limb at the suprapatellar and infrapatellar sites, in millimeters, measured by B-mode ultrasonography; serves as an internal control.
Time frame: Baseline and end of week 4
Change in body weight
Body weight in kilograms measured on the same calibrated scale, recorded to distinguish local tissue change from systemic weight change.
Time frame: Baseline and end of week 4
Correlation of subcutaneous thickness change with disease duration, age, and body mass index
Pearson correlation coefficients between the change in suprapatellar subcutaneous thickness of the affected limb and disease duration (months), age (years), and body mass index (kg/m2).
Time frame: Baseline and end of week 4
Plan to share: No
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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 completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Kayseri City Hospital