Prospective, controlled pilot study for the use of non-contact perfusion and thermography measurements in patients with peripheral arterial disease, chronic venous insufficiency, or diabetes mellitus (with or without ulceration) compared to patients with spider vein varikosis

• Conditions: Circulatory disorders in venous disease, arterial occlusive disease and diabetes mellitus in cf. to spider veins varicosis; I87; I70.2; E13; I83.9; Other disorders of veins; Atherosclerosis of arteries of extremities; Other specified diabetes mellitus; Varicose veins of lower extremities without ulcer or inflammation

• Registration Number: DRKS00013886
• Lead Sponsor: Phlebologisches Studienzentrum am Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-30
• Study Completion: 2018-02-26
• Results First Posted: 2021-05-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

•Men and women
• Age> 18 years
• written consent
• Possibility and will to participate
• Known vascular disease of the legs in defined stages (CVI C3-C6 or PAD
IIb-IV or diabetes mellitus with / without ulceration) or healthy leg vessels (spider veins / ret. Varices only)
• No surgical or interventional treatment of the legs / leg vessels in the last 6 months

Exclusion Criteria

• Lack of consent
• Lack of will or lack of opportunity to follow the examination protocol
• Acute thrombosis of the arterial or venous leg vessels
• Acute inflammation of the legs
• Extensive scars on the legs after trauma
• immobilization
• Pregnancy, breastfeeding
• Skin type IV to VI

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The target parameters are the non-contact perfusion and thermography measurements at the time of the conclusion visit.<br>Measured with:<br>Infrared thermography: target parameters:<br>1. Spatially resolved measurement of the temperature in the wound region.<br>2. Shape and size of the wound.<br><br>Near-infrared (PPGI): Target parameters:<br>1. Quantification of perfusion in the wound region.<br><br>Canon camera: target parameters:<br>1.Shape, size and color of the wound.<br><br>Hyperspectral camera: target parameters:<br>2. Quantification of wound region and environment perfusion by calculation of tissue oxygenation, near-infrared perfusion index, tissue hemoglobin index and tissue-water index of human tissue

Secondary Outcome Measures

Name	Time	Method
no secondary endpoints