Peripheral Arterial Disease Clinical Trial
Official title:
The Effects of Intermittent Negative Pressure on Peripheral Circulation in Dialysis Patients and Patients With Lower Limb Ischemia and Leg Ulcers
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.
n/a
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