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