Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06231940
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2024-01-08
Brief Title:
Efficacy of Complex Decongestive Therapy CDT in Patients With Venous Insufficiency a Experimental Study
Sponsor:
University of Salamanca
Organization:
University of Salamanca
Study Overview
Official Title:
Experimental Study on the Efficacy of Complex Decongestive Therapy CDT Treatment in Patients With Venous Insufficiency
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CDT
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 CDTs 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None