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

NCT ID: NCT06231940

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-09-30

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.

Detailed Description

The study hypothesizes that Complex Decongestive Therapy (CDT) is effective in increasing venous flow and reducing symptoms in patients with venous insufficiency. The primary objective is to demonstrate the effects of CDT in these patients. Secondary objectives include evaluating if physiotherapy treatment increases venous flow, decreases symptoms (edema, pain, heaviness, and fatigue), and improves patient quality of life, assessing adverse effects post-intervention, determining the reliability of circumferential edema measurement, and correlating venous insufficiency with various risk factors and aggravating conditions.

The design is a simple blind randomized clinical trial comparing an experimental group receiving CDT and lower limb exercise program to a control group doing standardized preventive measures. Participants include both men and women over 18 years old with clinical classification of C2-C5 venous insufficiency, excluding those with specific acute or unmanaged chronic conditions, or those currently or recently treated with CDT. The experimental group consists of 12 participants receiving CDT and exercise, while the control group includes 9 participants following the exercise program.

The study focuses on various variables to assess the effectiveness of Complex Decongestive Therapy (CDT) in patients with venous insufficiency, including venous reflux, flow and diameter of specific veins, intracellular and extracellular fluid volumes, and edema measurements at different lower limb sites. It also evaluates symptom severity and quality of life using validated questionnaires (CEAP, VCSS, CIVIQ-20).

Measurement tools include ultrasound for venous flow and diameter, bioimpedance for cellular fluids, and a tape measure for limb circumference. Assessments will be done using ultrasound and physiotherapy evaluations, along with patient-completed questionnaires.

The intervention involves pre and post-intensive 4-week CDT treatment evaluations, with a follow-up one month later. The experimental group undergoes twice-weekly CDT sessions, including manual lymph drainage, pneumatic compression, and bandaging, while the control group receives no treatment.

Conditions

Lymphatic Edema; Cellulitis of Leg; Vein Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Complex Decongestive Therapy (CDT) in venous insufficiency

Group Type: EXPERIMENTAL

Complex Decongestive Therapy (CDT) in venous insufficiency,

Intervention Type: 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:

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Complex Decongestive Therapy (CDT) in venous insufficiency,

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:

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Beatriz-María Bermejo-Gil

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beatriz María Bermejo Gil

Salamanca, Salamanca, Spain

Countries

Spain

Other Identifiers

CDT-USAL

Identifier Type: -

Identifier Source: org_study_id