Leg UlcerNCT06036485
Efficacy of Kerecis Omega 3 in Comparison to Clinical Standard Procedures
A study testing Kerecis Omega 3 and Surgical debridement in people with Leg Ulcer, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
Chronic leg ulcerations are a great burden for patients and the medical system alike. Frequent outpatient consultations with associated treatment costs and travel costs for the patient as well as psychosocial burdens remain an unmet problem in chronic wound care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcer
- What is being tested?
- Kerecis Omega 3 and Surgical debridement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 May 2023
- 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
- Any chronic leg ulcer > 4 weeks duration with delayed wound healing (reduction of wound surface of less than 40-50% within 4 weeks under adequate local therapy) without underlying treatable medical conditions
- Ulcer area at between 5cm2 and 60cm2
- Bacterial swab sampling prior to study
- Written study informed consent
Who cannot join
- History of Fish allergy or proven Fish allergy
- Pregnant or breast-feeding women
- Intention to become pregnant during the course of the study
- Wound not suitable for dressing: inflammation, fibrin coatings
- Inability to understand the study consent
About this study
Official title: Efficacy of Kerecis Omega 3 Versus Standard of Care in Patients With Chronic Leg Ulcerations - a Randomized Trial With a New In-wound Split Design Approach
Chronic leg ulcerations are a great burden for patients and the medical system alike. Frequent outpatient consultations with associated treatment costs and travel costs for the patient as well as psychosocial burdens remain an unmet problem in chronic wound care. There is an increasing need for definitive treatment of especially chronic venous and multifactorial chronic leg ulceration where arterial intervention is not a treatment option.
Minimal invasive surgical interventions that do not require skin grafting can be performed under local anesthesia in an outpatient setting even in multimorbid patients.
Read more
Kerecis Omega3 Wound is intact decellularized fish skin. The fish skin sheets contain fat, protein, elastin, glycans and other natural skin elements and it can be an effective treatment option in chronic leg ulcerations and is licensed for this use as a medical product in Switzerland. However, limited data without inter-wound bias is available for the use of Kerecis Omega 3 in chronic leg ulcerations.
In this study the investigators propose to investigate the efficacy of Kerecis Omega 3 according to objective wound surface measurements using standardized digital photographs in patients with chronic leg ulcerations. Efficacy will be evaluated against standard of care wound debridement.
- Conditions
- Leg Ulcer
- Being tested
- Kerecis Omega 3, Surgical debridement
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kerecis Omega 3Device
Decellularized intact fish skin developed for the management of chronic wounds
Surgical debridementProcedure or surgery
Superficial sharp surgical debridement technique
| Study group | Role | What they receive |
|---|---|---|
| Kerecis Omega 3 | Experimental | Not described Receives: Device: Kerecis Omega 3 |
| Surgical debridement | Active comparator | Not described Receives: Procedure: Surgical debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ulcer surface area
Change in ulcer surface area as assessed by standardized photography and digital imaging.
Measured: 12 weeks
Secondary outcomes (4)
Change in patient quality of life
Change in patient quality of life as assessed by the Wound-QoL questionnaire score, ranging from 0 to 4, with higher scores indicating a worse quality of life.
Measured: 2, 4, 6 and 12 weeks
Change in wound microbiota as assessed by alpha diversity of the microbial composition
Change in wound microbiota utilizing 16S-sequencing from wound swabs as assessed by alpha diversity of the microbial composition trough Shannon index, with higher scores indicating a more diversity of the species
Measured: 2, 4, 6 and 12 weeks
Change in wound microbiota as assessed by beta diversity of the microbial composition
Change in wound microbiota utilizing 16S-sequencing from wound swabs as assessed by beta diversity of the microbial composition trough Shannon index, with higher scores indicating a more diversity of the species.
Measured: 2, 4, 6 and 12 weeks
Change in ulcer surface area
Change in ulcer surface area as assessed by standardized photography and digital imaging.
Measured: 2, 4, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 May 2023
- Primary completion1 May 2023
- Study completion1 May 2023
Why it stopped: Lack of funding to support the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 in-wound split design with random allocation
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Bossart, MD, Principal investigator, Department of dermatology, University Hospital Inselspital, Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036485
- Sponsor's protocol ID
- Kerecis-1
- Status last verified
- Dec 2024
- First submitted
- 15 Mar 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Kerecis Omega 3 Versus Standard of Care in Patients With Chronic Leg Ulcerations - a Randomized Trial With a New In-wound Split Design Approach
- ClinicalTrials.gov ID
- NCT06036485
- Acronym / sponsor ID
- Kerecis-1
- Conditions
- Leg Ulcer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding to support the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 14 Sep 2023 (actual)
- 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.
Chronic leg ulcerations are a great burden for patients and the medical system alike. Frequent outpatient consultations with associated treatment costs and travel costs for the patient as well as psychosocial burdens remain an unmet problem in chronic wound care. There is an increasing need for definitive treatment of especially chronic venous and multifactorial chronic leg ulceration where arterial intervention is not a treatment option.
Minimal invasive surgical interventions that do not require skin grafting can be performed under local anesthesia in an outpatient setting even in multimorbid patients.
Kerecis Omega3 Wound is intact decellularized fish skin. The fish skin sheets contain fat, protein, elastin, glycans and other natural skin elements and it can be an effective treatment option in chronic leg ulcerations and is licensed for this use as a medical product in Switzerland. However, limited data without inter-wound bias is available for the use of Kerecis Omega 3 in chronic leg ulcerations.
In this study the investigators propose to investigate the efficacy of Kerecis Omega 3 according to objective wound surface measurements using standardized digital photographs in patients with chronic leg ulcerations. Efficacy will be evaluated against standard of care wound debridement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 in-wound split design with random allocation
| Arm | Type | Receives |
|---|---|---|
| Kerecis Omega 3 | Experimental | Device: Kerecis Omega 3 |
| Surgical debridement | Active comparator | Procedure: Surgical debridement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any chronic leg ulcer > 4 weeks duration with delayed wound healing (reduction of wound surface of less than 40-50% within 4 weeks under adequate local therapy) without underlying treatable medical conditions
- Ulcer area at between 5cm2 and 60cm2
- Bacterial swab sampling prior to study
- Written study informed consent
Key exclusion criteria (5 listed)
- History of Fish allergy or proven Fish allergy
- Pregnant or breast-feeding women
- Intention to become pregnant during the course of the study
- Wound not suitable for dressing: inflammation, fibrin coatings
- Inability to understand the study consent
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 |
|---|---|---|
| Kerecis Omega 3Decellularized intact fish skin developed for the management of chronic wounds | Device | Kerecis Omega 3 |
| Surgical debridementSuperficial sharp surgical debridement technique | Procedure or surgery | Surgical debridement |
Primary outcome
Change in ulcer surface area
Time frame: 12 weeks
Change in ulcer surface area as assessed by standardized photography and digital imaging.
4 secondary outcomes
Change in patient quality of life
Time frame: 2, 4, 6 and 12 weeks
Change in wound microbiota as assessed by alpha diversity of the microbial composition
Time frame: 2, 4, 6 and 12 weeks
Change in wound microbiota as assessed by beta diversity of the microbial composition
Time frame: 2, 4, 6 and 12 weeks
Change in ulcer surface area
Time frame: 2, 4, 6 and 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- 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.
Simon Bossart, MD principal investigator
Department of dermatology, University Hospital Inselspital, Bern
Questions about this trial
What is this clinical trial studying?
A study testing Kerecis Omega 3 and Surgical debridement in people with Leg Ulcer, run by Insel Gruppe AG, University Hospital Bern.
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 4 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: withdrawn, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 ulcer surface area (time frame: 12 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 6 Dec 2024.