Clinical trial NCT06231940: Efficacy of Complex Decongestive Therapy (CDT) in Patients With Venous Insufficiency: a Experimental Study
Official title: Experimental Study on the Efficacy of Complex Decongestive Therapy (CDT) Treatment in Patients With Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphatic Edema
Cellulitis of Leg
Vein Disease
Keywords: conservative treatment
Venous Insufficiency
Complex decongestive therapy
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 21
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group undergoes twice-weekly CDT sessions, including manual lymph drainage, pneumatic compression, and bandaging, while the control group receives no treatment.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Vein flow
timeFrame: pre-intervention and immediately after the intervention
measure: Internal saphenous vein diameter
timeFrame: pre-intervention and immediately after the intervention
measure: intracellular and extracellular fluid in each of the lower extremities
timeFrame: pre-intervention and immediately after the intervention
measure: lower extremities edema
timeFrame: pre-intervention and immediately after the intervention
measure: venous insufficiency involvement
timeFrame: pre-intervention and immediately after the intervention
measure: severity of venous insufficiency
timeFrame: pre-intervention and immediately after the intervention
measure: Perceived Quality of Life
timeFrame: pre-intervention and after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Beatriz María Bermejo Gil
Study officials:
References: