A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
A Prospective, Randomized, controlled pilot study enrolling up to 50 subjects at a singe investigational site in the US. Subjects with atherosclerotic peripheral arteria disease (PAD) presenting with critical limb ischemia (CLI) and one or more non-healing lower extremity arterial insufficiency ulcers who are suitable candidates for revascularization procedures (endovascular or surgical) will be randomized 1:1 to: * Wound care with the use of OxyGenesys(TM) Dissolved Oxygen Dressing, or * Standard Wound Care procedures An initial study phase will enroll up to 20 subjects (10 in each arm). Pending results of the initial study phase, the study may continue to enroll until up to 50 subjects (25 in each arm) have been enrolled. All subjects will be followed clinically and receive wound evaluation at 1, 3, and 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
OxyGenesys(TM) Dissolved Oxygen Dressing
Yale New Haven Hospital
New Haven, Connecticut, United States
Rate of Wound Healing
Percentage reduction in target wound area (length x width).
Time frame: 3 months
Incidence of Complete Wound Closure
number of wounds undergoing complete reepithelialization without drainage or dressing requirements, maintained for at least 2 weeks.
Time frame: 3 months
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