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