Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06231940
Other study ID # CDT-USAL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date September 30, 2024

Study information

Verified date January 2024
Source University of Salamanca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design


Intervention

Other:
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:

Locations

Country Name City State
Spain Beatriz María Bermejo Gil Salamanca

Sponsors (1)

Lead Sponsor Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vein flow vein flow by echograph pre-intervention and immediately after the intervention
Primary Internal saphenous vein diameter vein flow by echograph pre-intervention and immediately after the intervention
Primary 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
Primary lower extremities edema Measuring tape for limb circumference measurement pre-intervention and immediately after the intervention
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05661123 - Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis N/A
Recruiting NCT03199781 - Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy N/A
Completed NCT05023200 - The Personalised Antibiotic Duration for Cellulitis (PAD-C) Study
Recruiting NCT06283056 - RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite N/A
Not yet recruiting NCT05584007 - Cellulitis Optimal Antibiotic Treatment Phase 3
Completed NCT05624216 - Radiofrequency and Targeted Pressure Energy for Cellulite Reduction N/A
Completed NCT03846635 - Handheld Infrared Thermometer to Evaluate Cellulitis