- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03412929
A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wounds
March 30, 2020 updated by: Medline Industries
A Clinical Evaluation of a Manuka-Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Foot and Ankle 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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Lake In The Hills, Illinois, United States, 60156
- Northern Illinois Foot & Ankle Specialists
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Honey Impregnated Dressing
|
The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds.
The dressing provides a moist wound environment to help promote autolytic debridement.
The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Necrotic Tissue
Time Frame: From initial date of application to weekly visits assessed up to 4 weeks.
|
The percent change in necrotic tissue will serve as the primary endpoint.
|
From initial date of application to weekly visits assessed up to 4 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Closure
Time Frame: From initial date of application to weekly visits assessed up to 4 weeks.
|
Percent of patients with 100% wound closure in each group
|
From initial date of application to weekly visits assessed up to 4 weeks.
|
Infections
Time Frame: From initial date of application to weekly visits assessed up to 4 weeks.
|
Number of infections in the wound sites will be recorded.
|
From initial date of application to weekly visits assessed up to 4 weeks.
|
Odor
Time Frame: The odor score will be recorded at weekly visits over four weeks for each subject.
|
The odor score will be recorded using a scale of 1-4 with a score of 1 being pleasant odor to 4 being an unpleasant odor.
|
The odor score will be recorded at weekly visits over four weeks for each subject.
|
Pain Score
Time Frame: The pain score will be recorded at weekly visits over four weeks for each subject.
|
The pain score will be recorded with a visual analog scale from 0-10.
0 is interpreted as no pain and 10 is the worst imaginable pain.
|
The pain score will be recorded at weekly visits over four weeks for each subject.
|
Bates-Jensen Wound Assessment Tool Score
Time Frame: The BWAT score will be recorded at weekly visits over fours weeks for each subject.
|
The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status.
The Bates-Jensen Wound Assessment tool measures wound status.
The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score.
For all sub-score values, a value of 0 or 1 is a better outcome.
The minimum total score is 9 and the maximum total score is 65.
|
The BWAT score will be recorded at weekly visits over fours weeks for each subject.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2018
Primary Completion (Actual)
January 10, 2019
Study Completion (Actual)
May 28, 2019
Study Registration Dates
First Submitted
January 11, 2018
First Submitted That Met QC Criteria
January 25, 2018
First Posted (Actual)
January 29, 2018
Study Record Updates
Last Update Posted (Actual)
April 8, 2020
Last Update Submitted That Met QC Criteria
March 30, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R16-017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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