Lymphatic EdemaCDTNCT06231940
Efficacy of Complex Decongestive Therapy (CDT) in Patients With Venous Insufficiency: a Experimental Study
A study testing Complex Decongestive Therapy (CDT) in venous insufficiency, in people with Lymphatic Edema and Cellulitis of Leg, run by University of Salamanca at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Lymphatic Edema, Cellulitis of Leg, Vein Disease
- What is being tested?
- Complex Decongestive Therapy (CDT) in venous insufficiency,
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experimental Study on the Efficacy of Complex Decongestive Therapy (CDT) Treatment in Patients With Venous Insufficiency
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.
Read the 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
- Being tested
- Complex Decongestive Therapy (CDT) in venous insufficiency,
- Keywords
- conservative treatment, Venous Insufficiency, Complex decongestive therapy
- Medical subject headings
- Lymphedema, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex Decongestive Therapy (CDT) in venous insufficiency,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:
| Study group | Role | What they receive |
|---|---|---|
| Complex Decongestive Therapy (CDT) in venous insufficiency | Experimental | Not described Receives: Other: Complex Decongestive Therapy (CDT) in venous insufficiency, |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vein flow
vein flow by echograph
Measured: pre-intervention and immediately after the intervention
Internal saphenous vein diameter
vein flow by echograph
Measured: pre-intervention and immediately after the intervention
intracellular and extracellular fluid in each of the lower extremities
Bioimpedance meter for intracellular and extracellular segmental fluid measurement
Measured: pre-intervention and immediately after the intervention
lower extremities edema
Measuring tape for limb circumference measurement
Measured: pre-intervention and immediately after the intervention
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).
Measured: pre-intervention and immediately after the intervention
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)
Measured: pre-intervention and immediately after the intervention
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)
Measured: pre-intervention and after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Oct 2022
- Primary completion30 Dec 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz-María Bermejo-Gil, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231940
- Sponsor's protocol ID
- CDT-USAL
- Acronym
- CDT
- Status last verified
- Oct 2025
- First submitted
- 8 Jan 2024
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study on the Efficacy of Complex Decongestive Therapy (CDT) Treatment in Patients With Venous Insufficiency
- ClinicalTrials.gov ID
- NCT06231940
- Acronym / sponsor ID
- CDT / CDT-USAL
- Conditions
- Lymphatic Edema, Cellulitis of Leg, Vein Disease
- Keywords
- conservative treatment, Venous Insufficiency, Complex decongestive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Complex Decongestive Therapy (CDT) in venous insufficiency | Experimental | Other: Complex Decongestive Therapy (CDT) in venous insufficiency, |
| Control group | No intervention | – |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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: | Other | Complex Decongestive Therapy (CDT) in venous insufficiency |
Primary outcome
Vein flow
Time frame: pre-intervention and immediately after the intervention
vein flow by echograph
Internal saphenous vein diameter
Time frame: pre-intervention and immediately after the intervention
vein flow by echograph
intracellular and extracellular fluid in each of the lower extremities
Time frame: pre-intervention and immediately after the intervention
Bioimpedance meter for intracellular and extracellular segmental fluid measurement
lower extremities edema
Time frame: pre-intervention and immediately after the intervention
Measuring tape for limb circumference measurement
venous insufficiency involvement
Time frame: 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).
severity of venous insufficiency
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex Decongestive Therapy (CDT) in venous insufficiency, in people with Lymphatic Edema and Cellulitis of Leg, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vein flow (time frame: pre-intervention and immediately after the intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.