Wound HealNCT03412929
A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wounds
A study testing Honey Impregnated Dressing in people with Wound Heal and Necrotic Tissue Removal, run by Medline Industries at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal, Necrotic Tissue Removal
- What is being tested?
- Honey Impregnated Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2018to 28 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern Illinois Foot & Ankle Specialists
Lake in the Hills, Illinois, 60156
About this study
Official title: 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.
- Conditions
- Wound Heal, Necrotic Tissue Removal
- Being tested
- Honey Impregnated Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honey Impregnated DressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Honey Impregnated Dressing | Experimental | Honey Impregnated Dressing Receives: Device: Honey Impregnated Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Necrotic Tissue
The percent change in necrotic tissue will serve as the primary endpoint.
Measured: From initial date of application to weekly visits assessed up to 4 weeks.
Secondary outcomes (5)
Wound Closure
Percent of patients with 100% wound closure in each group
Measured: From initial date of application to weekly visits assessed up to 4 weeks.
Infections
Number of infections in the wound sites will be recorded.
Measured: From initial date of application to weekly visits assessed up to 4 weeks.
Odor
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.
Measured: The odor score will be recorded at weekly visits over four weeks for each subject.
Pain Score
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.
Measured: The pain score will be recorded at weekly visits over four weeks for each subject.
Bates-Jensen Wound Assessment Tool Score
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.
Measured: The BWAT score will be recorded at weekly visits over fours weeks for each subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start10 Jan 2018
- Primary completion10 Jan 2019
- Study completion28 May 2019
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412929
- Sponsor's protocol ID
- R16-017
- Status last verified
- Mar 2020
- First submitted
- 11 Jan 2018
- Last updated
- 8 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of a Manuka-Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Foot and Ankle Wounds
- ClinicalTrials.gov ID
- NCT03412929
- Acronym / sponsor ID
- R16-017
- Conditions
- Wound Heal, Necrotic Tissue Removal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Posted 20 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Honey Impregnated Dressing | Experimental | Device: Honey Impregnated DressingHoney Impregnated Dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Honey Impregnated DressingThe 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. | Device | Honey Impregnated Dressing |
Primary outcome
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.
5 secondary outcomes
Wound Closure
Time frame: 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.
Odor
Time frame: 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.
Bates-Jensen Wound Assessment Tool Score
Time frame: The BWAT score will be recorded at weekly visits over fours weeks for each subject.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honey Impregnated Dressing in people with Wound Heal and Necrotic Tissue Removal, run by Medline Industries at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Necrotic Tissue (time frame: From initial date of application to weekly visits assessed up to 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.