The Effects of Intermittent Negative Pressure on Wound Healing and Peripheral Circulation in Spinal Cord Injured Subjects
Condition: Wound Healing, Leg and Foot Ulcers, Macrocirculation, Microcirculation
MeSH terms: Foot Ulcer; Wounds and Injuries
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Intermittent negative pressure device
Intervention type(s): Device
Intervention description(s): This intervention study will be designed as a randomized cross-over study.
Other intervention name(s): FlowOx™ , Pulsating negative pressure device, Oscillating negative pressure device
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 16 week crossover pilot study comparing intermittent negative pressure (40mmHg) applied to the lower leg and foot plus standard best practice wound care comapred to standard best practice wound care alone.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment