A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wo… (NCT03412929) | Clinical Trial Compass
TerminatedNot Applicable
A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wounds
Stopped: Slow enrollment
United States8 participantsStarted 2018-01-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Change in Necrotic Tissue
Timeframe: From initial date of application to weekly visits assessed up to 4 weeks.