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The PulseFlowDF™ is designed to enhance blood circulation in the venules and arterioles in patients with diabetic foot ulcers of the lower extremities. PulseFlowDF is intended for patients in the home who would benefit from increased blood flow to: - · Treat and assist healing of cutaneous ulceration (wounds) - · Reduce wound healing time - · Enhance arterial circulation (blood flow) - · Prevent venous stasis (slowing of blood flow) - · Reduce compartmental pressures - · Reduce edema (swelling) - · Reduce post-operative pain and swelling - Reduce the need for anticoagulant medications (medications that thin the blood) and - · Prevent Deep Venous Thrombosis (DVT) (blood clots in the deep veins).

PulseFlowDF is an off-loading boot with a built in air bladder in the insole for intermittent plantar compression therapy. One active boot and one matched height inactive boot is provided. PulseFlowDF is designed to protect a diabetic wound during healing by (1) stimulating blood flow to the wound (and throughout the foot and leg) by means of cyclic inflation of an air bladder under the arch of the foot (primary action), (2) providing a protective cover for the wound which is bandaged and shielded inside the boot) and (3) stabilizing the foot and lower leg with an "off-loading design" that holds the foot and lower leg in a fixed position to reduce pressure on the sole of the foot (secondary action). PulseFlowDF allows the user to walk and move while wearing the boot. PulseFlowDF is worn for up to 10 to 15 hours per day for 12 weeks, after which time it can be converted to standard footwear.