I87.2
Conditions
Interventions
Group 1: In the course of the study, patients with CVI and additional complications will be monitored for 3 weeks with increasing compression pressure (the product has three defined pressure ranges, w
Sponsors
Städtisches Klinikum Dessau
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: - Patients with CVI between 18 and 85 years - CEAP C3-C6 - Comorbidities: light to moderate pAVK and/or DFS up to Wagner-Armstrong A2, PNP light to moderately pronounced
Exclusion criteria
Exclusion criteria: - Advanced PAVK (if any of these parameters apply: ABPI <0.5 , ankle artery pressure <60 mmHg, toe pressure < 30 mmHg or TcPO2 <20 mmHg instep) - Decompensated heart failure (NYHA III + IV) - Septic phlebitites - Phlegmasia coerulea dolens - Systemic infections (AIDS, hepatitis, tuberculosis) - Dementia patients- Pregnant women and nursing mothers - Participation in other clinical investigations / studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: - StO2 Oxygen saturation of hemoglobin in target tissue 1) by hyperspectral technology: at the following 3 measuring points: M1: 5x5cm, distal calf area above the gastrocnemius muscle M2: 5x5c in the middle of the dorsum of the foot M3: 3x3cm, in the middle of the malleolar fork 2.) by pulse oximetry: measuring points in the middle of the surfaces M1, 2, 3 (M 1', 2', 3') - Systematic collection and documentation of AEs | — |
Secondary
| Measure | Time frame |
|---|---|
| - NIR (deep perfusion) in target tissue (hyperspectral measuring) - TWI (Tissue Water Index) in target tissue (hyperspectral measuring) - THI hemoglobin in target tissue (hyperspectral measuring) Patient-Reported Outcomes: - Individual leg feeling assessment by questionnaire - Pain in the affected leg (here especially: lower leg and foot) using the visual analogue scale (0-10) - SF-12 - data collection wearing time h/d | — |
Countries
Germany
Contacts
Public ContactGeorg Daeschlein
Städtisches Klinikum DessauHochschulklinik für Dermatologie, Venerologie und Allergologie
Outcome results
None listed