Wound Healing, Leg and Foot Ulcers, Macrocirculation, Microcirculation Clinical Trial
Official title:
Acute and Long-term Clinical Effects of Intermittent Negative Pressure on Wound Healing in Spinal Cord and the Peripheral Circulation in Spinal Cord Injured Subjects
This is a pilot study to evaluate the treatment effect of INP on wound healing and tissue
perfusion for a larger randomized controlled trial (RCT). This randomized cross-over pilot
study will look at the effects of intermittent negative pressure (INP) therapy wound healing
and the peripheral macro- and microcirculation in spinal cord injured patients with chronic
leg and foot ulcers (6 weeks or more at inclusion). The project is designed as a randomized
clinical trial with single-subject multiple baseline design. We will perform convenience
sampling of spinal cord injured patients with leg and foot ulcers, with the last recruitment
by the end of december 2016.To ensure equal distribution of participants in each study arm,
we will perform block randomization. A statistician will randomized patients to either
intervention arm or control arm before start of the study: At baseline, each participants
will be randomized into either A) 8 weeks without intervention OR B) 8 weeks with start INP
therapy 2 hours per day divided into 2-3 timed sections. After the 8 weeks, participants in
the the control group (A) will be re-examined, and start 8-week INP therapy. Also the
intervention (INP) will be subjected to the same lower limb in each individual throughout the
study period. The other leg will act as a intra-individual control.
At baseline (week 0), and during the course of the study (every 4th week), the participants'
wounds will be measured by a wound nurse. Baseline (before start of INP therapy) and after
intervention the following measures will be performed: Demographic data (weight, height,
ABI), Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser
Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and
health surveys (SF-36/EQ-5D-5L and customized wound questionnaire) or similar will be
examined at baseline and and the end of the study period. Otivio AS has supplied the FlowOx
devices and provided the necessary training to perform this project. Outcome variables
assessed before and after the study period will be: wound healing (primary endpoint), quality
of life (secondary endpoint), skin perfusion pressure (secondary endpoint), ankle-brachial
pressure (secondary endpoint) and segmental pulse-volume recording (secondary endpoint). The
aim of this project is to prospectively examine and elucidate the effect of intermittent
negative pressure therapy applied to a limited part of the lower limb on clinically relevant
measures related to wound healing and peripheral macro- and microcirculation in patients with
spinal cord injury.
The hypotheses of the study are:
- Application of INP in patients with spinal cord injury, by the use of the FlowOx™
device, will improve wound healing in the foot compared to before treatment (baseline)
and compared to standard wound care alone.
- Application of INP in patients with spinal cord injury, by the use of the FlowOx™
device, will improve macro- and microcirculation in the foot compared to before
treatment (baseline) and compared to standard wound care alone in patients with spinal
cord injury.
- Application of INP in patients with spinal cord injury, by the use of the FlowOx™
device, will improve macro- and microcirculation in the intervention foot compared to
the control foot and compared to standard wound care alone in patients with spinal cord
injury.
n/a