An observational study in Lymphedema, Secondary Lymphedema and Breast Cancer-Related Lymphedema, sponsored by Ryazan State Medical University. Completed at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Ryazan State Medical University · Observational
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.
569 studies on the registry are indexed under Lymphedema; 136 are open to participants now.
This study's enrollment of 150 is above the median of 108 across 147 observational studies indexed under Lymphedema.
Browse Lymphedema studies →Ryazan State Medical University is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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Exclusion Criteria:
Patients with secondary unilateral lymphedema of the upper extremity (predominantly post-mastectomy etiology, 95.6%) receiving intensive phase CDT. ISL stages I-III.
Other: Intensive phase of Complete Decongestive Therapy
Patients with secondary unilateral lymphedema of the lower extremity of various etiologies (trauma, infection, CVI, oncological causes) receiving intensive phase CDT. ISL stages I-III.
Other: Intensive phase of Complete Decongestive Therapy
Patients with secondary bilateral lymphedema of the lower extremities of predominantly non-oncological etiology (infections 42.9%, CVI 14.3%) receiving intensive phase CDT. 48.6% of patients had ISL stage III.
Other: Intensive phase of Complete Decongestive Therapy
Standardized intensive phase of CDT according to International Society of Lymphology (ISL 2023) guidelines, including: (1) manual lymphatic drainage 45-60 min/session, (2) multilayer short-stretch compression bandaging, (3) remedial exercises in compression bandage, (4) skin care. Administered 5 times per week; duration individually determined by the treating physician based on clinical response (volume plateau or maximal tolerated therapy), typically ranging from 10 to 21 days.
Percentage Reduction of Limb Excess Size
For unilateral lymphedema: Percentage Reduction of Excess Indicator (PREI), calculated as the percentage decrease in the baseline excess of the Integral Perimeter Indicator (IPI, sum of squared circumferences at 7 standard points A-G) relative to the contralateral limb. For bilateral lymphedema: Relative reduction of the sum of circumferences of both limbs (ΣC) at points A-E, as a healthy contralateral reference is unavailable.
Time frame: From baseline to the completion of the intensive phase of CDT (variable duration), assessed up to 28 days (4 weeks) from baseline.
Change in Relative Limb Size Coefficient (ΔRLSC)
Absolute difference in the ratio of the affected limb IPI to the healthy limb IPI before and after CDT (applicable to unilateral groups only). Positive value corresponds to reduction in asymmetry.
Time frame: From baseline to the completion of the intensive phase of CDT (variable duration), assessed up to 28 days (4 weeks) from baseline.
Plan to share: Yes
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Ran from Jan 2024 to primary completion in Sep 2026, 32 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Ryazan State Medical University