A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wounds

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Evaluation of a Manuka-Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Foot and Ankle Wounds

Conditions
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Wound Heal, Necrotic Tissue Removal

Intervention / Treatment
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* Device: Honey Impregnated Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female at least 18 years of age Subject has a qualified chronic foot or ankle wound, sized 1cm2 to 25 cm2 for ≥ 4 weeks in duration Must have necrotic tissue at least 25% of wound area The wound type matches one of the indicated wounds listed on the product labeling: Leg ulcers Pressure ulcers Diabetic foot ulcers First and second degree burns Surgical wounds Trauma wounds Subject has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, consistent with adequate blood flow, within 3 months prior to study enrollment. If monophasic on exam, the non-invasive tests must display Ankle Brachial Index over 0.8 and no worse than mild disease on segmental pressures. Subject is likely to be compliant with instructions for case, such as following institutional standard of care directions, offloading, and keeping the wound area protected from environmental contaminants Type I/II diabetic subjects that meet the following criteria: Random blood glucose is less than 450 mg/dL within 30 days of the screening visit Exclusion Criteria: Subject has a known sensitivity or allergy to honey based products, bee venom, or other ingredients in product The subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation Wound duration ≥ 52 weeks The subject has a prognosis that indicated unlikely survival past the study period The subject is currently receiving dialysis Gangrene is present in the target wound Patient's wound is infected The subject's diagnosis indicates third degree burns The subject has received any treatment prior to study enrollment that may, in the opinion of an Investigator, affect the outcome of the study In the opinion of an Investigator, the subject is otherwise not suitable for study participation, such as the subject is likely to be non-compliant with study requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Honey Impregnated Dressing<br>Honey Impregnated Dressing | Device: Honey Impregnated Dressing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Necrotic Tissue | The percent change in necrotic tissue will serve as the primary endpoint. | From initial date of application to weekly visits assessed up to 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Closure | Percent of patients with 100% wound closure in each group | From initial date of application to weekly visits assessed up to 4 weeks. | 
| Infections | Number of infections in the wound sites will be recorded. | 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. | 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. | 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. | The BWAT score will be recorded at weekly visits over fours weeks for each subject. |