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Life sciences · Observational Study
ClinicalTrials.gov · October 16, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07878598). This is a study registration, not published results. Lead sponsor: Ryazan State Medical University. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 150 participants (ACTUAL). Conditions: Lymphedema, Secondary Lymphedema, Breast Cancer-Related Lymphedema, Upper Extremity Lymphedema, Lower Extremity Lymphedema After Gynecologic Cancer Surgery. Interventions: OTHER: Intensive phase of Complete Decongestive Therapy. Primary outcome measures: Percentage Reduction of Limb Excess Size , From baseline to the completion of the intensive phase of CDT (variable duration), assessed up to 28 days (4 weeks) from baseline.. Brief summary: Background: Complete decongestive therapy (CDT) is the standard treatment for lymphedema, but response varies by localization and laterality. Data on segmental distribution of therapeutic response and predictors of response are limited. Objective: To evaluate changes in lymphedema indicators after intensive-phase CDT, compare therapeutic response profiles across clinical subgroups, and develop a predictive model of response. Methods: Retrospective observational cohort study of 111 patients with secondary lymphedema: unilateral upper extremity, unilateral lower extremity, bilateral lower extremity. Primary outcome: percentage reduction of excess indicator (PREI) for unilateral groups and relative reduction of sum of circumferences (ΣC) for bilateral group. Secondary outcomes: topographic response profile (7 anatomical points), proportion of clinical responders (≥10%), predictive factors, and predictive model. Expected results: Identification of topographic heterogeneity of response, determination of factors of CDT resistance (especially in bilateral lymphedema), development of a validated predictive model for therapy personalization.