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

Not Applicable

Recruiting

• Conditions: Vein Disease; Cellulitis of Leg; Lymphatic Edema
• Interventions: Other: Complex Decongestive Therapy (CDT) in venous insufficiency,

• Registration Number: NCT06231940
• Lead Sponsor: University of Salamanca

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.

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2023-12-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-21
• Last Update Submitted: 2024-01-21
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complex Decongestive Therapy (CDT) in venous insufficiency	Complex Decongestive Therapy (CDT) in venous insufficiency,	-

Primary Outcome Measures

Name	Time	Method
Vein flow	pre-intervention and immediately after the intervention	vein flow by echograph
lower extremities edema	pre-intervention and immediately after the intervention	Measuring tape for limb circumference measurement
venous insufficiency involvement	pre-intervention and immediately after the intervention	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).
Internal saphenous vein diameter	pre-intervention and immediately after the intervention	vein flow by echograph
intracellular and extracellular fluid in each of the lower extremities	pre-intervention and immediately after the intervention	Bioimpedance meter for intracellular and extracellular segmental fluid measurement
severity of venous insufficiency	pre-intervention and immediately after the intervention	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)
Perceived Quality of Life	pre-intervention and after the intervention	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)

Trial Locations

Locations (1)

Beatriz María Bermejo Gil; 🇪🇸 Salamanca, Spain