Status:
TERMINATED
A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wounds
Lead Sponsor:
Medline Industries
Conditions:
Wound Heal
Necrotic Tissue Removal
Eligibility:
All Genders
18+ years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03412929
Start Date
January 10 2018
End Date
May 28 2019
Last Update
April 8 2020
Active Locations (1)
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1
Northern Illinois Foot & Ankle Specialists
Lake in the Hills, Illinois, United States, 60156