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

NCT04962048 | Terminated

• 1 other identifier: PSyNeP
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change of toleration / wellbeeing due to intervention of PSNP with Numeric Rating Scale

  Successful intervention with the PSNP device without harm to the patients. Change of toleration of the treatment and wellbeing of the subjects will be assessed by a Numerical Rating Scale (scale 0 - 10)

  2 times on day 1 and day 2

Secondary Outcomes (3)

• Change of microcirculation with laser doppler (LD)

  4 times on day 1 and 2; once on day 3

• Change of microcirculation with hyperspectral imaging (HS)

  4 times on day 1 and 2; once on day 3

• Change of microcirculation with thermal imaging (TH)

  4 times on day 1 and 2; once on day 3

Study Arms (1)

pulse-synchronized negative pressure (PSNP) device

EXPERIMENTAL

One leg will be treated with the pulse-synchronized negative pressure (PSNP). The other leg serves as non-treated control.

Device: pulse-synchronized negative pressure (PSNP) device; Other: Control - no intervention

Interventions

pulse-synchronized negative pressure (PSNP) device 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.

pulse-synchronized negative pressure (PSNP) device

Control - no intervention OTHER

The other leg serves as non-treated control

pulse-synchronized negative pressure (PSNP) device

Eligibility Criteria

• Age: 45 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female individuals suffering from DM type 2 and willing to participate in this study
• Age: 45-99
• Written consent of the participant after being informed

You may not qualify if:

• Skin lesions or dermatoses in the region of interest (ROI)
• Non-ability to comprehend the nature and course of the study

Sponsors & Collaborators

• Orputec: lead
• Medical University of Graz: collaborator
• Joanneum Research Forschungsgesellschaft mbH: collaborator

Study Sites (1)

Division of Plastic, Aesthetic and Reconstructive Surgery

Graz, Styira, 8036, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lars-Peter Kamolz, Univ.-Prof.

  Medical University of Graz, Graz, Styria, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After ensuring a comfortable position, each subject will receive treatment with the pulse-synchronized negative pressure (PSNP) device on one randomly chosen lower leg for 120 minutes.The non-invasive imaging (Laser-Doppler Imaging = LD , Hyperspectral Imaging = HS, Thermal Imaging = TH) will be performed before and after the intervention. This treatment course will be applied twice a day (with 4h +/- 2h in between) for two consecutive days. Toleration of the treatment and wellbeing of the subjects will be assessed by a Visual Analogue Scale. Finally, another series of imaging (LD, HS, TH) will be performed on the morning of the third day without a prior intervention.

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 14, 2021
• Study Start: May 28, 2021
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

AU (1)