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KerecisTM Omega3 Wound: the first fish skin substitute in the European Market for chronic wound care

Periodic Reporting for period 1 - Kerefish (KerecisTM Omega3 Wound: the first fish skin substitute in the European Market for chronic wound care)

Reporting period: 2019-11-01 to 2020-04-30

This study is a multi-center study in France, Germany, Italy, and Sweden on the healing effect of Kerecis® Omega3 Wound in severe diabetic ulcers and below-ankle amputational wounds compared to standard of care treatment for each country. This randomized controlled is designed to prove the efficacy of Kerecis™ Omega3 Wound for the indications it is intended for - severe diabetic foot ulcers - and to show the cost effectiveness of using Kerecis® Omega3 Wound over standard of care. Wounds resulting from an amputation that are left open reaching tendon or bone, or from a dehisced amputation where the sutures have unraveled, are included. Acute amputations where the metatarsal bones are exposed are included, provided that the patient has diabetes and the amputation is a result of an ulcer. This study is probably the first in his field where it aims to estimate the cost benefits of earlier closure of severe diabetic wounds, or the change of the deep and chronic wound into a smaller and shallower ulcer, and to radically alter its prognosis. In particular, the Frenchpart of the study was largely designed to ensure transparency of the financial calculations involved for cost-effectiveness by collecting detailed socio-economic data.

A study evaluating the prognosis of diabetic ulcers using a large data registry found that deeper, larger, and older ulcers take longer to heal. For wounds over 2 months of age, larger than 2 cm2 and reaching the bone or tendon, the probability of recovery in 20 weeks was 19%, with a cure rate of one in five. The average cost of healing a diabetic foot wound by wet healing (AMWH) was estimated at $2,566 per cm2, and the healing of a 3 cm2 wound would therefore cost at least $7,700.

Cell and/or tissue based wound treatment products (CTP’s) have been advancing the treatment of non-healing ulcers in the last 20 years. In 2013, a new product was approved in Europe and by the FDA; an intact fish skin graft, delivered as a sterilized, freeze-dried material, for the treatment of acute and chronic wounds. Fish skin from the north Atlantic cod has the benefit of not requiring antibiotic or antiviral treatment,thereby allowing the retention of natural components the skin. It and is a by-product of food industry and is therefore both ecologically sustainable as well as rich in naturally occurring bioactive molecules and omega-3 fatty acids.
A wealth of clinical experience on diabetic wounds exists on the Kerecis fish skin graft. This is, however, mainly in the form of case series and has been published through posters and case reports. Two randomized clinical trials have been performed with very positive results, but these focused on acute wounds, rather than chronic ones. The main indication for Kerecis is deep or non-healing diabetic ulcers, which are the biggest problem in diabetic wound care ultimately leading to amputation. Studies on other CTPs have almost solely been done on shallow diabetic ulcers to get a homogeneous study population which then is randomized to treatment with the studied product or the control product. This means that in the case of a favorable outcome in the study, those products are not really tested on the type of ulcer for which they are ultimately intended; ulcers where the next step is an amputation. In contrast,

The importance of this type of research to society lies in the urgent need of the 3 million European people suffering from diabetic foot ulcers. With a study like this we will have the supporting data and materials to create and deliver economically viable advanced treatment option for those patients. The studied treatment option results less complications and will promote fewer and shorter hospitalisations together with shorter healing times of DFU’s, less risk of amputation and an inreased quality of life.
Objectives:
Primary endpoint:
▪Proportion of healed ulcers at 16 weeks
▪Time to healing
Secondary endpoints:
▪Change in grade of ulcer in University of Texas class
▪Quality of life
▪Pain reduction
▪Healing trajectories measured by surface area on photos of acetate tracings and photos of ulcer.
▪Cost-effectiveness as calculated by global cost of wound treatment of the two arms and projected costs for non-healed ulcers
To develop this project, 12 diabetic foot wound treatment centers in France have been recruited to take part in the project, 2 hospitals have been recruited in Germany, 1 hospital in Sweden and 2 in Italy.
A clinical trial protocol was written for France and a statistical analysis plan done for the study within France with a biostatician from Ceridt. All documents required for the ethical committe/IRB approval for the study in France was submitted and was waiting approval within the reporting period.
Data management and protection plan was made by contracting 2 software companies (1 for France and 1 for Italy/Germany/Sweden) where data reported by electronic case report forms (eCRF) will be kept as well as all other clinical data and other non-identifiable information. CRF’s have been aligned so they are universal for all countries to ensure trial results will be comparable despite different healthcare settings. Kerecis will only ever receive non-identifiable health data and patient information through Smart Trial and ClinInfo linked to this study ID, which will consist of a number generated by the randomization process. Kerecis will have information on the subject´s age at enrolment and which study site the subject is enrolled, but not the subject´s name, birth date or other identifiable information.
Due to COVID-19 there have been delays in clinical trial agreement signatures for Sweden, Germany and Italy where doctors working in hospitals and other research personnell were prohibited to work on site and all study related work was either suspended or considerably decreased. The trial is set to recruit patients in hospitals and there was limited access from beginning of February through out the reporting period (30th of April). This has led to delays in starting recruitment and the training feasibilty study which should have started within the reporting period. In the meantime time was spent in refining the clinical trial protocols and strengthening administration coordination by hiring a full time project manager in Iceland to oversee all activities and projects.
We expect this study to validate Kerecis™ Omage3 Wound dressing as a treatment of complex wounds that is superior to the current SOC in Europe. In parallell economic impact study will be carried out in order to show the reduction in costs such as follow-up costs, hospitalization, fewer amputations and severe complications due to complex chronic DFU’s that don’t respond to other standard (conventional) care.
The KEREFISH project will enable Kerecis to demonstrate the cost-benefit of the Omega3 Wound fish skin graft as a treatment of chronic wounds, specifically in diabetic foot. The results of the clinical trials will enable Kerecis to achieve a total or partial reimbursement status for the product in the health systems of four European countries, This will reduce the price for health care providers and thus provide greater access of European patients to an advanced wound therapy ,thereby increasing their quality of life. The main goal of our commercialization strategy is to be the first company with a skin graft substitute reimbursed by the health systems across Europe.
Overview photo of the trial.
A published brouchure of Kerecis Omega Wound
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