Diabetes MellitusNCT01965665
Advancing the Standard of Care for Pin Site Care
A study testing MediHoney HCS dressing in people with Diabetes Mellitus and Open Reduction External Fixation, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to prospectively evaluate the effect of Active Leptospermum honey utilizing the MediHoney HCS dressing, on the occurrence of PIN site infections, and also to see if the use of MediHoney HCS reduces the frequency of dressing changes compared to published reports of routine standard pin site… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Diabetes Mellitus, Open Reduction External Fixation
- What is being tested?
- MediHoney HCS dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jun 2015
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A signed and dated informed consent has been obtained from the subject.
- Subject is able and willing to comply with study procedures.
- Subject is 18 years of age or older.
- Type I or II Diabetes
- Albumin >2.5
- A1C<12 or average fasting levels <200
Show all 11Show fewer
- ABI > .6 or biphasic pedal vessels by Doppler
- Charcot arthropathy of lower extremity
- Foot/ankle deformity
- Foot/ankle fracture
- Subject will undergo an Open Reduction with External Fixation (OREF).
Who cannot join
- A1C > 12
- ABI < .6 or monophasic pedal pulses on Doppler
- Recent (<2 months) or ongoing bone infection based on radiograph or scan
- Cellulitis of lower extremity within the last 2 months based on clinical exam and/or laboratory markers
- Honey or honey based allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center/Duke South Clinics/3J
Durham, North Carolina, 27710
About this study
Official title: Advancing the Standard of Care for Pin Site Care: Prospective Single Center Study Using Medihoney HCS
The purpose of this study is to prospectively evaluate the effect of Active Leptospermum honey utilizing the MediHoney HCS dressing, on the occurrence of PIN site infections, and also to see if the use of MediHoney HCS reduces the frequency of dressing changes compared to published reports of routine standard pin site care.
Read the detailed description
Up to 20 Diabetic Mellitus patients undergoing Open Reduction External Fixation (OREF) for foot and/or ankle fusions, fracture repair, or osteotomy will be enrolled to receive weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. No procedures, tests or interventions will be performed exclusively for research purposes or more frequently than the standard of care. Upon completion of the study, pin sites sepsis rates will be compared to published reports for standard pin site care.
- Being tested
- MediHoney HCS dressing
- Keywords
- Diabetes, Surgical Intervention, Honey
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MediHoney HCS dressingDevice
| Study group | Role | What they receive |
|---|---|---|
| Medihoney HCS dressing | Experimental | weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. Receives: Device: MediHoney HCS dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Pin Sites
total number of pin sites for all patients enrolled
Measured: Day of surgical intervention approximately 3hrs.
Number of Patients With Pin Site Infection
Patients will be assessed weekly for pin site infection up until frame removal.
Measured: weekly from baseline until frame removal, up to 16 weeks
Change in Sepsis Rate
Patients will be assessed weekly for sepsis or until frame is removed.
Measured: weekly from baseline until frame removal, up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2015
- Study completionJun 2015
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Kerzner, DPM, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965665
- Sponsor's protocol ID
- Pro00046972
- Status last verified
- Jun 2016
- First submitted
- 16 Oct 2013
- Last updated
- 31 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing the Standard of Care for Pin Site Care: Prospective Single Center Study Using Medihoney HCS
- ClinicalTrials.gov ID
- NCT01965665
- Acronym / sponsor ID
- Pro00046972
- Keywords
- Diabetes, Surgical Intervention, Honey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Posted 31 Oct 2016
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 prospectively evaluate the effect of Active Leptospermum honey utilizing the MediHoney HCS dressing, on the occurrence of PIN site infections, and also to see if the use of MediHoney HCS reduces the frequency of dressing changes compared to published reports of routine standard pin site care.
Detailed description
Up to 20 Diabetic Mellitus patients undergoing Open Reduction External Fixation (OREF) for foot and/or ankle fusions, fracture repair, or osteotomy will be enrolled to receive weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. No procedures, tests or interventions will be performed exclusively for research purposes or more frequently than the standard of care. Upon completion of the study, pin sites sepsis rates will be compared to published reports for standard pin site care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medihoney HCS dressing | Experimental | Device: MediHoney HCS dressingweekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A signed and dated informed consent has been obtained from the subject.
- Subject is able and willing to comply with study procedures.
- Subject is 18 years of age or older.
- Type I or II Diabetes
- Albumin >2.5
Key exclusion criteria (5 listed)
- A1C > 12
- ABI < .6 or monophasic pedal pulses on Doppler
- Recent (<2 months) or ongoing bone infection based on radiograph or scan
- Cellulitis of lower extremity within the last 2 months based on clinical exam and/or laboratory markers
- Honey or honey based allergy
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 |
|---|---|---|
| MediHoney HCS dressing | Device | Medihoney HCS dressing |
Primary outcome
Total Number of Pin Sites
Time frame: Day of surgical intervention approximately 3hrs.
total number of pin sites for all patients enrolled
Number of Patients With Pin Site Infection
Time frame: weekly from baseline until frame removal, up to 16 weeks
Patients will be assessed weekly for pin site infection up until frame removal.
Change in Sepsis Rate
Time frame: weekly from baseline until frame removal, up to 16 weeks
Patients will be assessed weekly for sepsis or until frame is removed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Kerzner, DPM principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MediHoney HCS dressing in people with Diabetes Mellitus and Open Reduction External Fixation, run by Duke University 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 11 inclusion and 5 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: finished, as of the sponsor's last update on 31 Oct 2016. 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 31 Oct 2016). 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?
Total Number of Pin Sites (time frame: Day of surgical intervention approximately 3hrs.). The study lists 3 primary outcomes in all. 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 31 Oct 2016.