The purpose of this study is to evaluate the effectiveness of a honey-impregnated wound dressing at removing necrotic tissue in subjects with chronic foot or ankle wounds.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage.
Northern Illinois Foot & Ankle Specialists
Lake in the Hills, Illinois, United States
Change in Necrotic Tissue
The percent change in necrotic tissue will serve as the primary endpoint.
Time frame: From initial date of application to weekly visits assessed up to 4 weeks.
Wound Closure
Percent of patients with 100% wound closure in each group
Time frame: From initial date of application to weekly visits assessed up to 4 weeks.
Infections
Number of infections in the wound sites will be recorded.
Time frame: From initial date of application to weekly visits assessed up to 4 weeks.
Odor
The odor score will be recorded using a scale of 1-4 with a score of 1 being pleasant odor to 4 being an unpleasant odor.
Time frame: The odor score will be recorded at weekly visits over four weeks for each subject.
Pain Score
The pain score will be recorded with a visual analog scale from 0-10. 0 is interpreted as no pain and 10 is the worst imaginable pain.
Time frame: The pain score will be recorded at weekly visits over four weeks for each subject.
Bates-Jensen Wound Assessment Tool Score
The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status. The Bates-Jensen Wound Assessment tool measures wound status. The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score. For all sub-score values, a value of 0 or 1 is a better outcome. The minimum total score is 9 and the maximum total score is 65.
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Time frame: The BWAT score will be recorded at weekly visits over fours weeks for each subject.