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NCT07878598

Efficacy of Complete Decongestive Therapy for Limb Lymphedema: Response Profile and Predictive Modeling

Sponsor: Ryazan State Medical University

View on ClinicalTrials.gov

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.

Official title: EFFICACY OF COMPLEX PHYSICAL DECONGESTIVE THERAPY FOR LIMB LYMPHEDEMA: RESPONSE PROFILE, COMPARISON BY LOCALIZATION, AND DEVELOPMENT OF A PREDICTIVE MODEL (A RETROSPECTIVE OBSERVATIONAL COHORT STUDY)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2024-01-01

Completion Date

2026-09-23

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

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.

Locations (1)

Ryazan State Medical University, Ministry of Health of Russia

Ryazan, Russia