Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Effects After Long-term Treatment
Condition: Peripheral Arterial Disease; Intermittent Claudication
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
Study type: Interventional

Summary: 
      Studies have shown that intermittent negative pressure (INP) can induce short-term increase
      in blood flow in the extremity in patients with peripheral artery disease (PAD). Case reports
      also have indicated that INP treatment has beneficial hemodynamic and clinical effects in
      patients with lower limb ischemia and hard to heal leg ulcers. However, the clinical and
      physiological effects of long-term INP treatment are not well documented and needs further
      investigation.
    

Detailed description: 
      A double-blinded randomized sham-controlled trial.

      Otivio AS is the developer of FlowOx, a noninvasive CE marked device to increase blood flow
      to the lower extremity. The device acts as a pressure chamber sealed around the patient's
      lower leg, applying pulses of intermittent negative pressure and atmospheric pressure. The
      pressure pulses are generated by a control unit, alternating between removing air from- and
      venting the pressure chamber.

      Preliminary tests indicate a significant increase in blood flow to the extremity during INP
      treatment at -40 mmHg, but a similar increase in blood flow was not detected during treatment
      INP treatment at -10 mmHg. Hence, treatment with -10 mmHg, may serve as a sham intervention,
      when evaluating the clinical and physiological effects of long-term INP treatment.

      All patients will receive best medical treatment including advice for smoking cessation,
      dietary advice, and advice for physical exercise, and pharmacological treatment with statins
      and platelet inhibitors. Patients will be randomized into two groups, one group receiving INP
      treatment with a pressure of -10 mmHg, the other group receiving INP treatment with a
      pressure of -40 mmHg. Treatment will be conducted by the patient him/herself at home, one
      hour in the morning and one hour in the evening for 12 weeks.

      Pain-free- and maximal walking distance, ankle-brachial index, arterial blood flow during
      application of INP, maximal blood flow, and biomarkers of inflammation and endothelial
      dysfunction will be registered at baseline and after 12 weeks to evaluate the effects of
      long-term INP treatment.
    

Intervention name(s): FlowOx
Intervention type(s): Device
Intervention description(s): FlowOx is a CE marked device developed to increase blood flow to the lower extremities. A pressure chamber is sealed around the leg below the knee and is connected to a control unit which induces pulses of 10 sec negative pressure, and 7 sec of atmospheric pressure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded randomized sham-controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment