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

Summary

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).

Conditions

• Microcirculation
• Diabetes

Interventions

DEVICE

pulse-synchronized negative pressure (PSNP) device

The machine consists of four components: an electrocardiograph (ECG), a vacuum pump, a software computing the timing of suction and drainage, and an individual suction cap for each patient. One leg will be treated with the PSNP-device. The treatment course with PSNP will be applied twice a day (with 4h +/- 2h in between) for two consecutive days.

OTHER

Control - no intervention

The other leg serves as non-treated control

Sponsors & Collaborators

• Medical University of Graz

  collaborator OTHER

• Joanneum Research Forschungsgesellschaft mbH

  collaborator OTHER

• Orputec

  lead OTHER

Principal Investigators

• Lars-Peter Kamolz, Univ.-Prof. · Medical University of Graz, Graz, Styria, Austria

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

45 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-28

Primary Completion

2022-05-17

Completion

2022-05-17

Countries

• Austria

Study Locations