Pressure UlcersNCT01348581
Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing
A study testing Marigen Wound Dressing in people with Pressure Ulcers and Venous Ulcers, run by Kerecis Ltd. at 1 site in Iceland.
Trial summary
The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds. The wound dressing is indicated for the management of difficult to heal and chronic wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers
- What is being tested?
- Marigen Wound Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteIceland
- Study dates
- Nov 2010to 1 Jan 2013
- 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
- Venous leg ulcer
- Arterial leg ulcer
- Rheumatic leg ulcer
- Hydrostatic leg ulcer
- Ulcer where healing is delayed because of drug therapy
- Non-healing ulcer due to known or unknown causes
Who cannot join
- Active infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Wound Treatment With Extracellular Matrix (ECM) Scaffold Made From Fish Proteins
The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds.
The wound dressing is indicated for the management of difficult to heal and chronic wounds. The matrix is cut to fit the wound and is applied to the wound bed. An absorptive secondary dressing is put on top. Further dressing of the wound depends on the etiology.
The indications for use are:
- partial and full-thickness wounds
- pressure ulcers
- venous ulcers
- diabetic ulcers
- chronic vascular ulcers
- tunneled/undermined wounds
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
- Conditions
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Chronic Ulcer of Foot, Trauma-related Wound
- Being tested
- Marigen Wound Dressing
- Keywords
- Adult, Aged, Aged, 80 and over, Bandages, Biological Dressings, Chronic Disease, Collagen, Epithelium, Extracellular Matrix, Fibroblasts, Granulation Tissue, Humans, Leg Ulcer, Middle Aged, Prospective Studies, Soft Tissue Injuries, Treatment Outcome, Varicose Ulcer, Wound Healing, Wounds and Injuries
- Medical subject headings
- Pressure Ulcer, Varicose Ulcer, Chronic Disease, Leg Ulcer, Soft Tissue Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marigen Wound DressingDevice
The dressing is changed at least twice a week, with no more than five days between dressing changes. It is extremely important that the dressings are changed sufficiently often. On highly exuding ulcers the three or four dressing changes per week may be necessary. Duration is four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Marigen Wound Dressing | Experimental | Not described Receives: Device: Marigen Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Measured: one year
Secondary outcomes (1)
Wound granulation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2012
- Study completion1 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerecis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348581
- Sponsor's protocol ID
- KERECIS-10-106-S1
- Other IDs
- MW-ECM
- Status last verified
- May 2011
- First submitted
- 4 May 2011
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Wound Treatment With Extracellular Matrix (ECM) Scaffold Made From Fish Proteins
- ClinicalTrials.gov ID
- NCT01348581
- Acronym / sponsor ID
- KERECIS-10-106-S1
- Conditions
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Chronic Ulcer of Foot, Trauma-related Wound
- Keywords
- Adult, Aged, Aged, 80 and over, Bandages, Biological Dressings, Chronic Disease, Collagen, Epithelium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Kerecis Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- 1 Jan 2013 (actual)
- First posted
- 5 May 2011 (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 clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds.
The wound dressing is indicated for the management of difficult to heal and chronic wounds. The matrix is cut to fit the wound and is applied to the wound bed. An absorptive secondary dressing is put on top. Further dressing of the wound depends on the etiology.
The indications for use are:
- partial and full-thickness wounds
- pressure ulcers
- venous ulcers
- diabetic ulcers
- chronic vascular ulcers
- tunneled/undermined wounds
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Marigen Wound Dressing | Experimental | Device: Marigen Wound Dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Venous leg ulcer
- Arterial leg ulcer
- Rheumatic leg ulcer
- Hydrostatic leg ulcer
- Ulcer where healing is delayed because of drug therapy
Key exclusion criteria (1 listed)
- Active infection
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 |
|---|---|---|
| Marigen Wound DressingThe dressing is changed at least twice a week, with no more than five days between dressing changes. It is extremely important that the dressings are changed sufficiently often. On highly exuding ulcers the three or four dressing changes per week may be necessary. Duration is four weeks. | Device | Marigen Wound Dressing |
Primary outcome
Wound healing
Time frame: one year
1 secondary outcome
Wound granulation
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 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.
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 Marigen Wound Dressing in people with Pressure Ulcers and Venous Ulcers, run by Kerecis Ltd. at 1 site in Iceland.
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 6 inclusion and 1 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 3 Mar 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 Iceland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wound healing (time frame: one year). 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 3 Mar 2017.