Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia

Launched by HALYARD HEALTH · Jan 23, 2014

Keywords

ClinConnect Summary

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)....

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or non-pregnant female \>=21 years of age
• • A clinical diagnosis of critical limb ischemia (CLI) with Rutherford classification stage 5
• • One or more chronic ulcers with a presumed etiology of arterial insufficiency and duration \>2 weeks. The target ulcer is defined as the highest-grade ulcer (Wagner's classification) at initial evaluation. For wounds with identical grading, the largest wound is the index wound
• • The patient or legally authorized representative is willing to provide informed consent and comply with specified follow-up evaluations
• • Undergoing intervention for infrainguinal or infrapopliteal artery disease (below the femoral artery bifurcation and above the ankle joint)
• • The index procedure resulted in successful revascularization. For endovascular procedures, successful revascularization is defined as complete revascularization of the target ulcer culprit vessels according to the angiosome treatment strategy, with a final percent diameter stenosis \>50% and improved distal flow by angiography following the procedure. For surgical procedures, successful revascularization is defined as a patent graft and improved distal flow following the procedure.
• Exclusion Criteria:
• • Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to index procedure.
• • Rutherford classification stage 0,1,2,3,4, or 6
• • Target wound duration \<2 weeks
• • Presence of frank gangrene (Wagner classification grade 4 or 5), major tissue loss (severe/extensive necrosis), or unsalvageable limb (extensive ischemic ulceration beyond the transmetatarsal level anticipated to require major amputation after the index procedure)
• • Previous or planned surgical or interventional procedure within 6 months before or 30 days after the index procedure, or any previous or planned target limb amputation.
• • Active local or systemic infection
• • Patients with ulcers judged by the examining physician to have a primary etiology other than ischemic arterial disease (e.g., venous related, decubitus, or other \[goug, pyoderma gangrenosum, necrobiosis lipoidica, vitamin B12 deficiency\])
• • Renal failure or chronic kidney disease with estimated glomerular filtration rate (eGFR \<30 ml/min/1.7sm sq. within 30 days of the index procedure or treated with dialysis)
• • Severly decreased cardiac output
• • Uncontrolled hyperglycemia
• • Patients with a known other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound data interpretation, or is associated with a life expectancy of less than 1 year
• • Patient is currently participating (or has participated in the last 30 days) in a study of any other investigational treatment.
• • Ulcer treatment with normothermic or hyperbaric oxygen therapy, recombinant or autologous growth factor products, or use of enzymatic debridement
• • Concomitant medications such as corticosteroids, immunosuppressive medications, or chemotherapy
• • Acute thrombus in the target limb