Microcirculation clinical trials

The Influence of Pulse-synchronized Negative Pressure on the Dermal Microcirculation

The technology of the pulse-synchronous alternating pressure system has been patented and is ready for application. Since the device is a combination of commercially available products with a software controlling the duration/initiation of the negative pressure, no harm for the study participant is expected. With no adequate preclinical model of impaired microcirculation being available, and due to the non-invasive nature of the device, the rationale to test the product in a controlled setting in clinical patients is justified. The intervention takes place twice a day for two consecutive days with objective assessment of the microcirculation before and after the intervention. Thereby, the immediate effect of the intervention is to be evaluated. A fifth assessment takes place on the third day without prior intervention to assess a possible long-term effect (comparison against first measurement - base line). The primary aim of this project is to investigate the tolerability and the comfort of pulse-synchronized negative pressure (PSNP) applied by the device manufactured by Orputec GmbH on the dermal microcirculation. Evaluation of patient comfort and tolerability will be performed by a Numerical Rating Scale (NRS). The application of the device (PSNP) significantly influences the dermal microcirculation (measuring by LD, HS, TH). The aims of this project is to investigate the tolerability / comfort and the effect of pulse-synchronized negative pressure (PSNP) applied by the device manufactured by Orputec GmbH on the dermal microcirculation. Objective evaluation of microcirculation with laser doppler (LD), hyperspectral imaging (HS), thermal imaging (TH).