Efficacy of Complex Decongestive Therapy (CDT) in Patients With Venous Insufficiency: a Experimental Study

NCT06231940 | Completed DMC

• 1 other identifier: CDT-USAL
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigates the effectiveness of Complex Decongestive Therapy (CDT) in improving venous flow and reducing symptoms in venous insufficiency patients. The primary goal is to demonstrate CDT's effects, with secondary goals assessing symptom relief, life quality improvement, and adverse effects. The trial is a simple blind randomized design, involving an experimental group receiving CDT plus exercises and a control group doing exercises alone. Participants are adults with specific classifications of venous insufficiency, excluding certain health conditions. The study will involve 12 participants in the experimental group and 9 in the control group.

Conditions

Lymphatic Edema; Cellulitis of Leg; Vein Disease

Keywords

conservative treatment; Venous Insufficiency; Complex decongestive therapy

Outcome Measures

Primary Outcomes (7)

• Vein flow

  vein flow by echograph

  pre-intervention and immediately after the intervention

• Internal saphenous vein diameter

  vein flow by echograph

  pre-intervention and immediately after the intervention

• intracellular and extracellular fluid in each of the lower extremities

  Bioimpedance meter for intracellular and extracellular segmental fluid measurement

  pre-intervention and immediately after the intervention

• lower extremities edema

  Measuring tape for limb circumference measurement

  pre-intervention and immediately after the intervention

• venous insufficiency involvement

  CEAP questionnaire (Clinical, Etiologic, Anatomic, and Pathophysiologic).CEAP Classification for Chronic Venous Disorders. Ranges from C0 to C6. The minimum on the clinical scale is C0 (no signs of venous disease). The maximum is C6 (active venous ulcer).

  pre-intervention and immediately after the intervention

• severity of venous insufficiency

  Venous Clinical Severity Score (VCSS). Includes 9 clinical categories, each scored from 0-3. Minimum score 0 (no symptoms or signs). Mazimum score 27 (the wors severy, severe venous disease)

  pre-intervention and immediately after the intervention

• Perceived Quality of Life

  Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20). It consists on 20 questions scored on5-point likert scale. Minimum score 20 (best possible quality of life, leas impact of venous insufficiency) maximum score 100 (worst quality of life)

  pre-intervention and after the intervention

Study Arms (2)

Complex Decongestive Therapy (CDT) in venous insufficiency

EXPERIMENTAL

Other: Complex Decongestive Therapy (CDT) in venous insufficiency,

Control group

NO INTERVENTION

Interventions

Complex Decongestive Therapy (CDT) in venous insufficiency, OTHER

Complex Decongestive Therapy (CDT) is a comprehensive treatment approach primarily used for lymphedema and related conditions, but it's also beneficial for chronic venous insufficiency and other edematous conditions. CDT aims to reduce swelling and maintain the reduction, improve skin condition, and alleviate symptoms. It typically involves two phases: an intensive phase to reduce swelling as much as possible and a maintenance phase to sustain the achieved results. The main components of CDT include: Manual Lymph Drainage (MLD),Compression Therapy, Exercise, Skin Care, Education and Self-Care:

Complex Decongestive Therapy (CDT) in venous insufficiency

Eligibility Criteria

• Age: 35 Years - 75 Years
• Gender Eligibility Details: self-identified gender will be included and gender identity question will be ask to analyze gender-diverse related to health correlations
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 35 and 75 years
• Presence of mild venous insufficiency, moderate or severe (grades C1, C2, C3, and C4 on the Clinical, Etiologic, Anatomic, Pathophysiologic \[CEAP\] scale).

You may not qualify if:

• Subjects affected by uncompensated acute cardiac, hepatic, and renal disease, acute obstructive vascular disease, acute trauma, primary lymphedema, and acute skin infections.
• Patients who are currently receiving complex decongestive therapy treatment or in the last six months.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Beatriz María Bermejo Gil

Salamanca, Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Lymphedema; Venous Insufficiency

Interventions

carbohydrate-deficient transferrin

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The experimental group undergoes twice-weekly CDT sessions, including manual lymph drainage, pneumatic compression, and bandaging, while the control group receives no treatment.

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 30, 2024
• Study Start: October 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: September 30, 2024
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

ES (1)