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NCT07198698

Sahid Method for Secondary Unilateral Lower Limb Lymphedema

Not yet recruiting NA Last updated 30 September 2025
What this trial tests

NA trial testing Paloma Sahid Method, a patented technique (PCT/CL2023/050061) in Lymphedema in 32 participants. Not yet recruiting.

Timeline
1 November 2025
Primary endpoint
30 December 2025
30 March 2026

Quick facts

Lead sponsorUniversity Diego Portales
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment32
Start date1 November 2025
Primary completion30 December 2025
Estimated completion30 March 2026
Sites1 location across Chile

Drugs / interventions tested

Conditions studied

Sponsor

University Diego Portales

Who can join

Adults 30 to 65, female only, with Lymphedema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Manual lymphatic drainage (MLD) is a non-invasive technique frequently used in the management of lymphedema. The Paloma Sahid Method is a patented approach to lymphatic drainage that combines specific manual and mechanical maneuvers and compression. This single-arm clinical trial will evaluate its effects on lower-limb circumference, functional capacity, and quality of life in adult women with secondary unilateral lymphedema. Thirty-two women aged 30-65 years with stage I-II secondary lymphedema affecting one lower limb will be enrolled through referrals from vascular physicians in public and private centers in the Metropolitan Region of Santiago, Chile. Participants will attend two pre-intervention visits: (1) study information and informed consent; (2) baseline assessments including thermography, body composition and BMI (bioimpedance), blood pressure and heart rate, limb volume by circumferential tape measurements, muscle strength by handheld dynamometry, quality of life (LYMQOL), and function (Lower Extremity Functional Scale, LEFS). A randomized subsample of 10 participants will undergo lymphoscintigraphy before and after treatment to characterize lymphatic circulation. The intervention consists of 12 sessions of lymphatic drainage using the Paloma Sahid Method, delivered three times per week over one month (about 80 minutes per session). Maneuvers follow linear sliding patterns directed toward regional lymph nodes and are complemented by compression therapy. After completing the 12 sessions, all baseline assessments are repeated. The primary objective is to determine change in lower-limb circumference from pre- to post-intervention. Secondary objectives include changes in functional capacity, quality of life, thermographic patterns, body composition, muscle strength, hemodynamic measures, and, in the subsample, lymphoscintigraphy findings. The study aims to provide rigorous clinical evidence on a promising, non-surgical option for individuals living with lymphedema.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Lymphedema

Currently open trials in the same condition.

Other University Diego Portales trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07198698.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing