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
Verified date | August 2016 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | December 7, 2016 |
Est. primary completion date | April 11, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 96 Years |
Eligibility |
Inclusion Criteria: - Able and willing to provide informed consent - Age: 18-96 years - Affected foot/shoe size <46 (approximate foot length< 29,5 cm) - Receiving hemodialysis =3 times per week for 1 hour per treatment OR - Peripheral arterial disease and leg ulcer Exclusion criteria: - Incapable to consent voluntarily, i.e. patients who are not able to consent due to their mental status, or who are not willing or able to perform the negative pressure therapy in a sitting position - Not adhering to the INP therapy program - Patients with an expected life-span less than 3 months - Patients in whom the remaining limb is non-functional, for example due to previous stroke - Patients in which a deep venous thrombosis or pulmonary embolism is suspected - Limbs with uncontrolled infection - Previous lumbar sympathectomy - Bilateral amputation of lower extremity |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital - Ullevål, Department of Nephrology | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Otivio AS, University of Oslo |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Segmental Skin Perfusion Pressure | Fully automated and quantitative evaluation of microcirculatory perfusion in the skin of the foot and leg (Sensilase, Vasamed, USA). Multiple levels can be assessed on limbs; bilateral measurement helps to manage test time Not susceptible to interference effects from medial calcification Requires use of pressure cuffs to occlude blood flow for specified time period in order to evaluate reactive hyperemic response to controlled release of pressure Graphical output of pressure and perfusion during cuff deflation indicates the pressure (mmHg) at which skin perfusion is found to return in addition to pressure contour |
8 weeks | |
Primary | Life Quality (SF-12 or EQ-5D-5L) | SF-12 or EQ-5D-5L | 8 weeks | |
Primary | Pulse Volume Recording / segmental volume plethysmography (PVR) | PVR shows variations in the volume of blood passing through a limb during each cardiac cycle. The instrument that will be used to measure PVR for this study is Sensilase (Vasamed, USA) OR MacroLab (STR Teknikk, strteknikk.no, Aalesund, Norway). Multiple levels can be assessed on limbs. The measures are not susceptible to interference effects from medial calcification. |
8 weeks | |
Primary | Wound healing (Measuring wound diameter and length) | Measurement of healing to provide a means by which progress over time to wound closure can be identified. A wound nurse will take pictures at study start and at follow-up. | 8 weeks | |
Primary | Ankle-Brachial Pressure Index (ABPI) | The ratio of the blood pressure at the ankle (dorsal pedis artery/posterior tibial artery) to the blood pressure in the upper arm (brachial artery) | 8 weeks |
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