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| Name | Class |
|---|---|
| Kerecis Ltd. | INDUSTRY |
| RCTs | INDUSTRY |
| Clininfo S.A. | INDUSTRY |
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The KereFish study is a randomized controlled study to study the efficacy of Kerecis Omega3 Wound on deep diabetic ulcers. This study is probably the first in his field: in this one, the Kerecis Omega3 Wound dies are used on the types of wounds for which they are ultimately intended. This study aims to document 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. The study, carried out in France, uses the pre-existing home nursing system with the transmission of photographs to the reference centre. The study was largely designed to ensure transparency of the financial calculations involved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | treatment with the device Kerecis Omega3 Wound |
|
| Control Group | No Intervention | treatment with SOC treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kerecis Omega3 Wound | Device | Treatment of the wound with Kerecis Omega3 Wounds matrices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound area | measuring the surface of the wound with planimetry software | Week 0 |
| Wound area | measuring the surface of the wound with planimetry software | Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dured DARDARI, MD | Centre Hospitalier Sud Francilien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Caen | Caen | 14033 | France | |||
| Centre Hospitalier Sud Francilien |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36556977 | Derived | Dardari D, Potier L, Sultan A, Francois M, M'Bemba J, Bouillet B, Chaillous L, Kessler L, Carlier A, Jalek A, Sbaa A, Orlando L, Bobony E, Detournay B, Kjartansson H, Bjorg Arsaelsdottir R, Baldursson BT, Charpentier G. Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study): An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale. Medicina (Kaunas). 2022 Dec 1;58(12):1775. doi: 10.3390/medicina58121775. |
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| Corbeil-Essonnes |
| 91100 |
| France |
| CHU de Dijon - Bocage Sud | Dijon | 21000 | France |
| Hotel Dieu Le Creusot | Le Creusot | 71200 | France |
| CHU de Montpellier | Montpellier | 34295 | France |
| Hôpital Cochin | Paris | 75014 | France |
| Hopital Bichat-Claude Bernard | Paris | 75018 | France |
| CHU de Reims - Hôpital Debré | Reims | 51100 | France |
| Hôpital de Roubaix - CETRADIM | Roubaix | 59100 | France |
| CHU de Nantes Hôpital Nord Laennec | Saint-Herblain | 44093 | France |
| CHRU de Strasbourg - Hopital Civil | Strasbourg | 67091 | France |
| CHU de Toulouse Hôpital Rangueil | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |
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