3-week monitoring of compression therapy in patients with underlying venous disease (C3-C6) and concomitant DFS, PNP and/or pAVK using a hyperspectral camera and NIRS measurement to check safety using the medical adjustable compression system circaid juxtalite

Not Applicable

Recruiting

Conditions: I87.2
Venous insufficiency (chronic)(peripheral)

Registration Number: DRKS00022987

Lead Sponsor: Städtisches Klinikum Dessau

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 22

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

- 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety:<br>- StO2 Oxygen saturation of hemoglobin in target tissue<br>1) by hyperspectral technology: at the following 3 measuring points:<br> M1: 5x5cm, distal calf area above the gastrocnemius muscle<br> M2: 5x5c in the middle of the dorsum of the foot<br> M3: 3x3cm, in the middle of the malleolar fork<br>2.) by pulse oximetry: measuring points in the middle of the surfaces M1, 2, 3 (M 1', 2', 3')<br>- Systematic collection and documentation of AEs<br>

Secondary Outcome Measures

Name	Time	Method
- NIR (deep perfusion) in target tissue (hyperspectral measuring)<br>- TWI (Tissue Water Index) in target tissue (hyperspectral measuring)<br>- THI hemoglobin in target tissue (hyperspectral measuring)<br><br>Patient-Reported Outcomes:<br>- Individual leg feeling assessment by questionnaire<br>- Pain in the affected leg (here especially: lower leg and foot) using the visual analogue scale (0-10)<br>- SF-12<br>- data collection wearing time h/d<br>