Clinical trial NCT03412929: A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wounds
Official title: A Clinical Evaluation of a Manuka-Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Foot and Ankle Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound Heal
Necrotic Tissue Removal
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2018-01-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Necrotic Tissue
timeFrame: From initial date of application to weekly visits assessed up to 4 weeks.
Secondary outcomes:
measure: Wound Closure
timeFrame: From initial date of application to weekly visits assessed up to 4 weeks.
measure: Infections
timeFrame: From initial date of application to weekly visits assessed up to 4 weeks.
measure: Odor
timeFrame: The odor score will be recorded at weekly visits over four weeks for each subject.
measure: Pain Score
timeFrame: The pain score will be recorded at weekly visits over four weeks for each subject.
measure: Bates-Jensen Wound Assessment Tool Score
timeFrame: The BWAT score will be recorded at weekly visits over fours weeks for each subject.
Other outcomes:
Locations:
city: Lake In The Hills
country: United States
facility: Northern Illinois Foot & Ankle Specialists
state: Illinois
Study officials:
References: