Prospective, controlled study of compression therapy in patients with obesity-associated functional chronic venous insufficiency
- Conditions
- E66.0Obesity due to excess calories
- Registration Number
- DRKS00015468
- Lead Sponsor
- VenenzentrumSt. Maria-Hilf Krankenhaus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 49
Men and women
- Age > 18 years
- BMI 30-40 kg/m2
- Written consent
- Opportunity and willingness to participate
- Clinical picture of functional chronic venous insufficiency in the legs (edema, hyperpigmentation, redness, dermatoliposclerosis, erosions), CEAP stages C3-C5
- No therapy with medical compression stockings (MCS) in the last 3 months
- Absolute contraindications for medical compression stockings (MCS)
- ABI <0.6 or absolute ankle artery pressure <60mmHg
- hemodynamically relevant insufficiency of the superficial or deep veins
- Considerable mobility restrictions (walker, walking aid, wheelchair)
- Decompensated edema diseases (e.g. renal insufficiency, hepatic insufficiency, heart failure)
- known allergy to the material of foot and mouth disease
- Taking drugs that could significantly influence the symptoms of the symptoms to be observed (e.g. glucocorticoids above the Cushing's threshold, regular use of painkillers)
- inability to put on or take off the foot and mouth alone, possibly with aids (pimpled gloves, big butler)
- Florid leg ulcer, CEAP stage C6
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method complaint score<br>Collection of the complaint score, daily, separately for each leg<br>Indication of the gestation period of the foot-and-mouth disease per day, daily from phase II onwards<br>Survey on the wearing comfort of FMD from Phase II onwards<br><br><br>Method of the complaint score (German translation of VVSymQ , Kind 2015, Paty 2015):<br>Patients answer the following question daily between 18:00 and 22:00 hours: <br>How many times since getting up this morning have you noticed the following symptoms on your leg? Feelings of heaviness, pain, swelling, throbbing and itching.<br>The possible answers for each question with the corresponding score are as follows:<br>At no time: Score 0<br>Rarely: Score 1<br>Some time: Score 2<br>Over a long period: Score 3<br>Most of the time: Score 4<br>All the time: Score 5<br>Score values 0-25<br><br>VVSympQ - Varicosis Veins Symptoms Questionnaire
- Secondary Outcome Measures
Name Time Method Wearing time MCS (medical compression stockings) per day (min. 8 hours)<br>Clinical picture and skin condition on the legs<br>wearing comfort<br>Physical activity with/without MCS measured by activity index <br>Handling (dressing / undressing) of the MKS<br><br>