CompletedNot Applicable

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

Spain21 participantsStarted 2022-10-01

Plain-language 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.

Who can participate

Age range

35 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vein flow

Timeframe: pre-intervention and immediately after the intervention

Internal saphenous vein diameter

Timeframe: pre-intervention and immediately after the intervention

intracellular and extracellular fluid in each of the lower extremities

Timeframe: pre-intervention and immediately after the intervention

lower extremities edema

Timeframe: pre-intervention and immediately after the intervention

venous insufficiency involvement

Timeframe: pre-intervention and immediately after the intervention

severity of venous insufficiency

Timeframe: pre-intervention and immediately after the intervention

Perceived Quality of Life

Timeframe: pre-intervention and after the intervention

Trial details

NCT IDNCT06231940

SponsorUniversity of Salamanca

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

View on ClinicalTrials.gov More Lymphatic Edema trials

Plain-language summary

Who can participate

Age range

35 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Vein flow

Timeframe: pre-intervention and immediately after the intervention

Internal saphenous vein diameter

Timeframe: pre-intervention and immediately after the intervention

intracellular and extracellular fluid in each of the lower extremities

Timeframe: pre-intervention and immediately after the intervention

lower extremities edema

Timeframe: pre-intervention and immediately after the intervention

venous insufficiency involvement

Timeframe: pre-intervention and immediately after the intervention

severity of venous insufficiency

Timeframe: pre-intervention and immediately after the intervention

Perceived Quality of Life

Timeframe: pre-intervention and after the intervention