Management of diabetic foot in France. Dr DARDARI Dured MD.PhD. Centre hospitlaier Sud Francilien. CERTITD.
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1 Management of diabetic foot in France. Dr DARDARI Dured MD.PhD. Centre hospitlaier Sud Francilien. CERTITD.
2 Diabetic foot in France. Diabetic foot associated with nephrological complications are the leading cause of death in diabetic patients. * Between 2010 and 2013, the incidence rate for lower limb amputation (LLA) remained stable. On the other hand, that of wounds foot increased from 558 to 668/ people diabetic, an increase of 20%. ** In 2013, in France, the incidence rate of people treated for diabetes hospitalized for LLA and foot ulcers were 252/100,000 et 668/100,000, respectively. ** * INVS bulletin hebdomadaire 14 novembre 2015 ** Fosse-Edorh S, Mandereau-Bruno L, Hartemann-Heurtier A. Les hospitalisations pour complications podologiques chez les personnes diabétiques traitées pharmacologiquement, en France en Bull Epidémiol Hebd. 2015;(34-35):638-44
3 Diabetic foot in France; ** Fosse-Edorh S, Mandereau-Bruno L, Hartemann-Heurtier A. Les hospitalisations pour complications podologiques chez les personnes diabétiques traitées pharmacologiquement, en France en Bull Epidémiol Hebd. 2015;(34-35):638-44
4 Diabetic foot in France. The highest level of amputation was the toe in 52% of cases, the foot (19%), the leg (17%) and the thigh (12%).* Among the diabetic people who are amputated at of a lower limb amputation, 20% are re-amputated at least once during the year. The rate of rehospitalization in the year for foot score is 30%. * Fosse-Edorh S, Mandereau-Bruno L, Hartemann-Heurtier A. Les hospitalisations pour complications podologiques chez les personnes diabétiques traitées pharmacologiquement, en France en Bull Epidémiol Hebd. 2015;(34-35):638-44
5 Diabetic foot in France; The "diabetic foot" resulted in 35,900 stays hospitals in 2003, of which 20,300 in the surgical sector, is over the five years previous average annual increase of 8.8% for all hospitalizations confused, and 17.5% for surgical stays The direct cost of the management of diabetic foot in France for 2007 was estimated between 1,000 and 20,000 euros/ wound, depending on whether the lesions are infected or not, and that of an amputation of the lower limbs to nearly 32,000 euros. * Unkown indirect cost. *Rapport pied diabétique-has 2007
6 Diabetic foot in France rganisation for Economic Co-operation and Development, (OECD) data Taux d amputation des membres inférieurs liée au diabète, 15 ans et plus, 2007 Total Femmes Hommes Marge Marge Marge Marge Marge d'erreur d'erreur d'erreur d'erreur d'erreur (total) (total) Female (femmes) (femmes) Male (hommes) Marge d'erreur (hommes) Total Etats-Unis1 (2006) 35,7 0,2 0,2 23,1 0,3 0,3 50,8 0,4 0,4 Espagne 26,5 0,5 0,5 13,0 0,5 0,5 43,3 1,0 1,0 Portugal 23,0 0,9 0,9 14,1 1,0 1,0 33,8 1,8 1,8 Belgique (2006) 21,3 0,9 0,9 11,6 0,9 0,9 33,6 1,8 1,8 Danemark 20,9 1,3 1,3 12,0 1,3 1,3 31,0 2,3 2,3 Suisse (2006) 15,7 0,9 0,9 6,9 0,8 0,8 27,2 1,9 1,9 OCDE 14,7 8,2 22,8 France 12,6 0,3 0,3 6,2 0,3 0,3 20,9 0,6 0,6 Suède 12,1 0,7 0,7 7,2 0,7 0,7 18,6 1,3 1,3 Nouvelle-Zélande 11,9 1,2 1,2 8,4 1,4 1,4 16,5 2,1 2,1 Pays-Bas (2005) 11,4 0,6 0,6 6,9 0,6 0,6 17,0 1,0 1,0 Canada 11,3 0,5 0,5 5,9 0,5 0,5 18,0 0,9 0,9 Finlande 11,2 0,9 0,9 5,8 0,9 0,9 17,7 1,8 1,8 Norvège 10,9 1,0 1,0 5,3 0,9 0,9 18,7 2,1 2,1 Pologne2 (2006) 10,7 0,4 0,4 7,0 0,4 0,4 15,0 0,7 0,7 Italie (2006) 10,5 0,3 0,3 6,3 0,3 0,3 15,7 0,5 0,5 Irlande 10,3 1,2 1,2 3,8 1,0 1,0 18,6 2,4 2,4 Royaume-Uni 9,0 0,3 0,3 4,4 0,2 0,2 14,6 0,5 0,5 Corée 7,7 0,3 0,3 3,8 0,3 0,3 12,5 0,7 0,7 Autriche (2006) 6,6 0,6 0,6 3,8 0,6 0,6 10,0 1,1 1,1
7 Diabetic foot cost in Europe (amputations). ost of diabetic foot in France, Spain, Italy, Germany and United Kingdom:A systematic review. Annales d endocrinologie 79 (2017) 67-74
8 Diabetic foot cost in Europe. Direct cost of gangrene in diabetic foot. Indirect cost and total cost were not reported by any study. Study Year Courency Country Setting Gangrene No of Subjects Ray , euro Germany National database Ray , euro France National database 2016 $ NR 4713 NR 3352 Ray , euro Spain National database NR 8301 Von Ferber, 2007 NR not reported 2001, euro Germany Health insurance database NC cannot be calculated Cost of diabetic foot in France, Spain, Italy, Germany and United Kingdom:A systematic review. Annales d endocrinologie 79 (2017) 67-74
9 Diabetic foot in France; Good or bad resultes?
10 Diabetic foot in France; multidisciplinary foot unite.
11 Diabetic foot in France; All types of diabetic foot care are supported by general and basic health assurance: Moving the patient form his home to the hospital in double way. Ambulatory and long-term hospitalization costs. Care and treatment at home and during the recovery period. Almost the majority of dressings and conventional treatment. Off-loading orthesis shoes.
12 Diabetic foot in France.
13 Diabetic foot in France. 4 podiatry sessions/year are reimbursed for grade 2 IWGDF podiatry risk. 6 podiatry sessions/year are reimbursed for grade 3 IWGDF podiatry risk.
14 Diabetic foot in France; In 2007, according to Entred study data, 40% of doctors had not graded the podological risk. Only 34% will do all of their 6 session Average length of hospital stay for the diabetic foot is 19 days** * Etude ENTRED * *Données nationale PMSI 2015
15 Diabetic foot in France. Dressing Cutaneous subtituts in France are not available.
16 Diabetic foot in France. Local traitement. Negative pressure therappy Vactherapie Pico Larvae therapy.
17 J+6 pose K2 J+0 pose K1 amputation 10/04/2018 J+13 pose K3
18 J+27 J+20 pose K4 J+112
19 avant détersion, J0 pose K1 amputation 25/10/2017 APRES DETERSION, KERECIS- J0
20 J+7 pose k2 J+14 POSE K3 J+21 K4
21 J+35 K5 J+40 K6 J+49 5 mois après la 1 ère matrice
22 KEREFISH STUDY 20/09/
23 SeVere Diabetic foot wound 8500 amputations per year 7000 re-admissions for recurrent severe ulcers University of Texas : classification of diabetic foot ulcers Explorer Study (ref. 1): wounds > 1 cm² and grade IC or IIC, which corresponds to 3.9% of severe foot wounds in diabetics according to Ref. 2 KereFish: grade IIA or B and grade III A or B which corresponds to : 44.2% of severe diabetic foot wounds in the USA (Ref. 2) approximately 23% at the Centre Hospitalier Sud Francilien (CERITD personal data) (% = Prevalence of amputations within each wound category (according to ref. 2) (1) Edmonds M, Lancet Diabetes Endocrinol Dec 2017 (2) Armstrong DG Diabetes Care 1998:21 (5):
24 Global Objective & strategy To obtain the reimbursement in France for the Kerecis Omega 3 Wound At the highest possible price! A medico-economic study: 2 groups randomized to provide data-based evidence on: The safety The efficacy The cost of treatment versus other alternative (relevant comparator) 24
25 KEREFISH STUDY: OBJECTIVES Main objective: to demonstrate the superiority of Kerecis Omega3 Wound vs conventional treatment for the treatment of diabetic wounds. Main criterion: percentage of wounds healed with complete epithelialization at 16 weeks. Secondary objectives: to evaluate the safety of Kerecis Omega3 Wound and to evaluate the cost of treatment in both groups. Secondary criteria: Safety and security Other efficiency criteria Costs Patient and medical staff satisfaction 25
26 Centres & investigators CAEN REIMS 24 investigation Centers among which: 12 investigation Centers designated in the initial submission - 5 essential, already accepted - 7 additional & essential (choice to be finalized) TALENCE CHSF TOULOUSE if needed, a list of 11 additional with interesting potential, to be added via a protocol amendment Total of 206 patients to be analyzed, corresponding to 229 patients recruited 26
27 Thank you for your attention.
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