UlcerNCT02482948
MEDIHONEY® Gel Versus Collagenase for Wound Debridement
A study testing Active Leptospermum Honey (Medihoney) and Collagenase in people with Ulcer and Wounds, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
The purpose of this study is to compare how well two products, Active Leptospermum Honey (ALH) (MEDIHONEY® Gel) and Collagenase (Santyl®), in removing the nonviable (non living) tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Active Leptospermum Honey (Medihoney) and Collagenase
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- A signed and dated informed consent has been obtained from the subject.
- Subject is able and willing to comply with study procedures.
- Subject is able to comply with weekly visits.
- Subject is 18 years of age or older.
- There is presence of at least 50% or greater necrotic tissue (including slough and eschar) in the wound bed and a total wound surface area of > 1cm2 to < 64cm2.
- Subject will not have currently used parenteral or oral antibiotics except for UTI.
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- Diabetic subjects: HbA1c < 12.0 % within 90 days preceding enrollment.
- Pre-albumin greater than 16 mg/dl within 90 days preceding enrollment.
- Subject with a pressure ulcer must be currently receiving adequate pressure redistribution to the affected area via group 2 or 3 specialty bed, a static wheel chair cushion while patient is out of bed.
- Subject with diabetic plantar surface ulcer will use an offloading boot if ambulatory.
- Subject with a venous ulcer must be currently receiving and using compression therapy that can be managed daily.
- Subject and caregiver are trainable and able to perform dressing changes.
- Subject has no allergies to collagenase or honey.
- Subject has no allergies to semi-occlusive or absorptive secondary dressing.
- If subject has multiple wounds only the wound that fits the inclusion criteria will be selected. If more than one wound meets criteria then the largest wound will be selected.
Who cannot join
- Steroid use >5mg daily.
- Subject is unable to cooperate with offloading and/or compression recommendations.
- ABI = or >0.8 if the wound is located on a lower extremity.
- Wound has the presence of callus requiring sharp or surgical debridement within 3 days prior to randomization and/or needs debridement using any method other than the study agent throughout study treatment.
- Subject has medical instability as deemed by the investigator.
- Subject is pregnant.
- Subject has participated in another clinical trial or wound dressing evaluation in the 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Prospective, Randomized, Multi-Center, Efficacy Non-inferiority Study of MEDIHONEY® Gel Versus Collagenase for Wound Debridement"
The purpose of this study is to compare how well two products, Active Leptospermum Honey (ALH) (MEDIHONEY® Gel) and Collagenase (Santyl®), in removing the nonviable (non living) tissue.
Read the detailed description
BACKGROUND
An important aspect of wound bed preparation for healing or grafting is the recognition that wounds often have underlying pathogenic abnormalities that cause necrotic tissue to accumulate. Therefore, in order to facilitate wound progression, repeated removal of necrotic tissue may be necessary as long as the wound is chronic. Debridement is defined as the removal of nonviable material, foreign bodies, and poorly healing tissue from a wound. Although surgeons recognize the importance of debridement, few data have been generated in randomized trials to support its use. Traditionally, debridement has been undertaken as a single therapeutic step within defined time frames. The most direct form of debridement is surgical excision. Although this may be applicable for acute wounds, it is unlikely to remove the necrotic burden that may continually accumulate in a chronic wound. Although there are other forms of debridement including enzymatic and biologic; in the case of non-healing wounds, the form of debridement with the most compelling evidence of healing efficacy is autolytic debridement , Therefore, for patients who are poor candidates for surgical debridement or have limited access to a surgeon, autolytic debridement may be considered an effective form of continuous debridement.
2.1 Primary Objective
The primary objective of this study is to evaluate the non-inferiority of MEDIHONEY® Gel (Active Leptospermum Honey-ALH Gel) compared to (Santyl) Collagenase, two FDA cleared/approved treatments, with respect to the percent reduction of necrotic (including slough and eschar) tissue in the wound at the end of 14 days +/- 2 days.
2.2 Secondary Objective
The secondary objective of this study is to compare the two treatment groups with respect to the percent reduction from randomization for necrotic tissue (including slough and eschar) at weeks 1, 3 and 4 +/- 2 days.
- Being tested
- Active Leptospermum Honey (Medihoney), Collagenase
- Keywords
- Debridement, collagenase, leptospermum honey
- Medical subject headings
- Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Leptospermum Honey (Medihoney)Device
Also called Medihoney
STudy agent to be applied to the wound daily.
CollagenaseDrug
Also called Santyl
Study agent to be applied daily to the wound.
| Study group | Role | What they receive |
|---|---|---|
| Collagenase | Active comparator | This is an enzymatic debridement agent to remove non-viable tissue from wounds to be applied daily Receives: Drug: Collagenase |
| Active leptospermum honey | Active comparator | This is an active medicinal grade honey used to promote autolytic debridement and applied daily Receives: Device: Active Leptospermum Honey (Medihoney) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Necrotic tissue reduction
Necrotic tissue percent reduction in the wound at the end of 14 days
Measured: two weeks
Secondary outcomes (1)
Percent wound reduction
Percent wound reduction from randomization at weeks 1, 3 and 4.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Poor enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UlcerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravi Patel, MD, Principal investigator, Innovative Healing Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482948
- Sponsor's protocol ID
- Derma-MH001
- Status last verified
- Nov 2017
- First submitted
- 12 Jun 2015
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Prospective, Randomized, Multi-Center, Efficacy Non-inferiority Study of MEDIHONEY® Gel Versus Collagenase for Wound Debridement"
- ClinicalTrials.gov ID
- NCT02482948
- Acronym / sponsor ID
- Derma-MH001
- Keywords
- Debridement, collagenase, leptospermum honey
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
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 compare how well two products, Active Leptospermum Honey (ALH) (MEDIHONEY® Gel) and Collagenase (Santyl®), in removing the nonviable (non living) tissue.
Detailed description
BACKGROUND
An important aspect of wound bed preparation for healing or grafting is the recognition that wounds often have underlying pathogenic abnormalities that cause necrotic tissue to accumulate. Therefore, in order to facilitate wound progression, repeated removal of necrotic tissue may be necessary as long as the wound is chronic. Debridement is defined as the removal of nonviable material, foreign bodies, and poorly healing tissue from a wound. Although surgeons recognize the importance of debridement, few data have been generated in randomized trials to support its use. Traditionally, debridement has been undertaken as a single therapeutic step within defined time frames. The most direct form of debridement is surgical excision. Although this may be applicable for acute wounds, it is unlikely to remove the necrotic burden that may continually accumulate in a chronic wound. Although there are other forms of debridement including enzymatic and biologic; in the case of non-healing wounds, the form of debridement with the most compelling evidence of healing efficacy is autolytic debridement , Therefore, for patients who are poor candidates for surgical debridement or have limited access to a surgeon, autolytic debridement may be considered an effective form of continuous debridement.
2.1 Primary Objective
The primary objective of this study is to evaluate the non-inferiority of MEDIHONEY® Gel (Active Leptospermum Honey-ALH Gel) compared to (Santyl) Collagenase, two FDA cleared/approved treatments, with respect to the percent reduction of necrotic (including slough and eschar) tissue in the wound at the end of 14 days +/- 2 days.
2.2 Secondary Objective
The secondary objective of this study is to compare the two treatment groups with respect to the percent reduction from randomization for necrotic tissue (including slough and eschar) at weeks 1, 3 and 4 +/- 2 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagenase | Active comparator | Drug: CollagenaseThis is an enzymatic debridement agent to remove non-viable tissue from wounds to be applied daily |
| Active leptospermum honey | Active comparator | Device: Active Leptospermum Honey (Medihoney)This is an active medicinal grade honey used to promote autolytic debridement and applied daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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 able to comply with weekly visits.
- Subject is 18 years of age or older.
- There is presence of at least 50% or greater necrotic tissue (including slough and eschar) in the wound bed and a total wound surface area of > 1cm2 to < 64cm2.
Key exclusion criteria (7 listed)
- Steroid use >5mg daily.
- Subject is unable to cooperate with offloading and/or compression recommendations.
- ABI = or >0.8 if the wound is located on a lower extremity.
- Wound has the presence of callus requiring sharp or surgical debridement within 3 days prior to randomization and/or needs debridement using any method other than the study agent throughout study treatment.
- Subject has medical instability as deemed by the investigator.
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 |
|---|---|---|
| Active Leptospermum Honey (Medihoney)Also: MedihoneySTudy agent to be applied to the wound daily. | Device | Active leptospermum honey |
| CollagenaseAlso: SantylStudy agent to be applied daily to the wound. | Drug | Collagenase |
Primary outcome
Necrotic tissue reduction
Time frame: two weeks
Necrotic tissue percent reduction in the wound at the end of 14 days
1 secondary outcome
Percent wound reduction
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Poor enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
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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.
Ravi Patel, MD principal investigator
Innovative Healing Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Leptospermum Honey (Medihoney) and Collagenase in people with Ulcer and Wounds, run by Integra LifeSciences Corporation 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 15 inclusion and 7 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 2 Dec 2017. 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?
The study was stopped early (reason given: Poor enrollment.). Results are not available in the source record.
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?
Necrotic tissue reduction (time frame: two 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 2 Dec 2017.