The Effects of INP on Peripheral Circulation in Dialysis Patients and Patients With PAD and Leg Ulcers

Summary

This experimental study will look at the effects of INP therapy for two patient groups: 1) patients with reduced peripheral circulation and chronic wounds in patients with renal disease (dialysis patients); 2) and peripheral arterial disease and leg ulcers. The project is designed as a non-randomized clinical trial with single-subject multiple baseline design. Also the intervention will be subjected on the same leg for each individual throughout the study period. The other leg will act as a control. A baseline measure with patient history collection will be performed before a four-week intervention period. These measures include: Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and a health survey (SF-12/EQ-5D-5L) or similar. After four weeks and eight weeks of intervention, the same tests will be repeated. A final follow-up test will be two weeks after cessation of the intermittent negative pressure intervention. The study will look at the effect of INP on renal failure patients who are given dialysis at a dialysis center located at Oslo University Hospital, Ullevål. Otivio AS has supplied the FlowOx devices and provided the necessary training to perform this project. Outcome variables assessed before, during and after the 10-week study period will be: wound healing, quality of life, skin perfusion pressure and segmental pulse-volume recording. The aim of this project is to prospectively examine and elucidate the effect of intermittent negative pressure therapy on clinically relevant measures related to the reduction of peripheral macro- and microcirculation in patients with renal failure undergoing dialysis treatment.

The hypothesis of the study is:

* Application of INP in patients with renal failure, by the use of the FlowOx™ device, will improve wound healing and peripheral circulation in the foot compared to before treatment (baseline) in patients undergoing dialysis treatment.
* Application of INP in patients with PAD, by the use of the FlowOx™ device, will improve macro- and microcirculation and wound healing in the foot compared to before treatment (baseline) in patients with chronic wounds.

Conditions

• Renal Disease
• Peripheral Arterial Disease
• Arterial Leg Ulcers

Interventions

DEVICE

FlowOx™

FlowOx™ uses intermittent negative and atmospheric pressure, and is intended for use as an adjunct non-invasive therapy for the treatment of reduced peripheral circulation. Negative pressure cycles are created by alternating between removing air and venting the vacuum-chamber to atmospheric pressure. The vacuum cycle is controlled by the Control Unit (Pump). FlowOx™ is designed to assists wound healing indirectly by improving blood flow to the affected limb and augmenting the wound healing effect of the contact dressings and any associated medication. Treatment is planned to be applied while the participants are seated and it does not interfere with other activities normally enjoyed while seated. Treatment is recommended for one to two hours per session aiming to improve blood flow in the affected area and thus the clinical outcomes.

Sponsors & Collaborators

• Otivio AS

  collaborator INDUSTRY

• University of Oslo

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Jonny Hisdal, PhD · Oslo University Hospital - Aker

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

96 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-11

Primary Completion

2016-04-11

Completion

2016-12-07

Countries

• Norway

Study Locations