Critical Limb Ischemia
Conditions
Keywords
Critical Limb Ischemia, Non Healing Wounds, Diabetic Wounds, Foot Ulcers
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOxygenesys(TM) Dissolved Oxygen Dressing
OxyGenesys(TM) Dissolved Oxygen Dressing
Sponsors
Yale University
Halyard Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Wound Healing | 3 months | Percentage reduction in target wound area (length x width). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Complete Wound Closure | 3 months | number of wounds undergoing complete reepithelialization without drainage or dressing requirements, maintained for at least 2 weeks. |
Countries
United States
Participant flow
Pre-assignment details
The randomization of subjects to either of the two treatments (OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care) in this study was not indicated on each of the case report forms of the seven subjects enrolled.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | NA Participants |
| Age, Categorical >=65 years | NA Participants |
| Age, Categorical Between 18 and 65 years | NA Participants |
| Sex: Female, Male Female | NA Participants |
| Sex: Female, Male Male | NA Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Rate of Wound Healing
Percentage reduction in target wound area (length x width).
Time frame: 3 months
Population: Study subjects were not available to provide data when the primary outcome was to be reported, and thus there are no primary outcome data to report.
Secondary
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
Population: Study subjects were not available to provide data when the secondary outcome was to be reported, and thus there are no secondary outcome data to report.