E66.0
Conditions
Interventions
Group 1: Study process
The study takes 5 weeks for each patient.
- Week 1 is a preliminary phase without wearing MCS (Medical compression stocking) (phase I).
- In week 2 two different MCS are worn o
Sponsors
VenenzentrumSt. Maria-Hilf Krankenhaus
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complaint score Collection of the complaint score, daily, separately for each leg Indication of the gestation period of the foot-and-mouth disease per day, daily from phase II onwards Survey on the wearing comfort of FMD from Phase II onwards Method of the complaint score (German translation of VVSymQ , Kind 2015, Paty 2015): Patients answer the following question daily between 18:00 and 22:00 hours: 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. The possible answers for each question with the corresponding score are as follows: At no time: Score 0 Rarely: Score 1 Some time: Score 2 Over a long period: Score 3 Most of the time: Score 4 All the time: Score 5 Score values 0-25 VVSympQ - Varicosis Veins Symptoms Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Wearing time MCS (medical compression stockings) per day (min. 8 hours) Clinical picture and skin condition on the legs wearing comfort Physical activity with/without MCS measured by activity index Handling (dressing / undressing) of the MKS | — |
Countries
Germany
Contacts
Public ContactMaren Hoffmann
VenenzentrumSt. Maria-Hilf Krankenhaus
Outcome results
None listed