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      Matrix therapy is a cost-effective solution to reduce amputation risk and improve quality of life: pilot and case studies

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      1 , 2 , 2 , 3 , 4 , *

      Regenerative Medicine Research

      EDP Sciences

      Matrix therapy, CACIPLIQ20, OTR4120, ischemic skin ulcers

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          Abstract

          Introduction: Chronic, non-healing ulcers remain one of the most challenging clinical situations for health care practitioners. Often, conventional treatments fail and lead to amputation, further decreasing the patient's quality of life and resulting in enormous medical expenditures for healthcare systems. Here we evaluated the use of and cost-effectiveness of the RGTA (ReGeneraTing Agents) medical device CACIPLIQ20 (OTR4120) for chronic lower-extremity ulcers in patients with Leriche and Fontaine Stage IV peripheral arterial disease who were not eligible for revascularization. Methods: This uncontrolled pilot study included 14 chronic lower extremity ulcers in 12 patients in one hospital. The pilot study included 12 patients with TcPO 2 < 20 mm Hg and ABPI < 0.5 who had either a minimum of one chronic lower extremity ulcer or a chronic ulcer related to amputation. OTR4120 was applied twice a week or until complete healing, for up to 12 weeks. Ulcer surface area reduction (%)after 2, 4, 8 and 12 weeks, appearance after 4 weeks, and healing after 12 weeks were measured and recorded. Results: A 35% reduction in ulcer size was achieved after 4 weeks. 7 (50%) out of 14 ulcers completely healed within 1 to 3 months of treatment. Discussion: OTR4120 is an effective therapeutic option for patients with chronic lower extremity ulcers, can provide major improvement of quality of life and has the added benefit of being a significant cost-effective solution for healthcare systems.

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          Most cited references 14

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          Reamputation, mortality, and health care costs among persons with dysvascular lower-limb amputations.

          To examine 12-month reamputation and mortality rates as well as acute and postacute medical care costs among a large cohort of persons with dysvascular amputations. Retrospective cohort study. General community. Medicare beneficiaries identified from the Centers for Medicare and Medicaid Services data as undergoing a lower-limb amputation secondary to vascular disease in 1996. Not applicable. Twelve-month reamputation and mortality rates, and acute and postacute medical care costs, by initial amputation level and presence or absence of diabetes. A total of 3565 persons, corresponding to 71,300 Medicare beneficiaries nationwide, were identified from the claims data as undergoing lower-limb amputations in 1996. Twenty-six percent of them required subsequent amputation procedures within 12 months, and more than one third died within 1 year of their index amputation. Acute and postacute medical care costs associated with caring for beneficiaries with a dysvascular amputation exceeded $4.3 billion yearly. There were marked differences in patient characteristics, progression of amputation to higher levels, service use, and mortality among dysvascular amputees with and without a comorbidity of diabetes. Diabetic amputees were younger than those without diabetes; they were also more likely to be men, to have more comorbidities, and to have undergone their first amputation at an earlier age than persons with dysvascular amputations who did not have diabetes. Although diabetic amputees were less likely to die within 12 months of the index amputation, they died at a significantly younger age than their nondiabetic counterparts. Progression to a higher level of limb loss occurred most frequently (34.5%) among persons with an initial foot or ankle amputation. Diabetic amputees were more likely than nondiabetic amputees to experience progression to a higher amputation level for all initial amputation levels. This study provides information that can be used by physicians when counseling patients about expected outcomes of dysvascular amputations at different levels.
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            Systematic review of economic evaluations of human cell-derived wound care products for the treatment of venous leg and diabetic foot ulcers

            Background Tissue engineering is an emerging field. Novel bioengineered skin substitutes and genetically derived growth factors offer innovative approaches to reduce the burden of diabetic foot and venous leg ulcers for both patients and health care systems. However, they frequently are very costly. Based on a systematic review of the literature, this study assesses the cost-effectiveness of these growth factors and tissue-engineered artificial skin for treating chronic wounds. Methods On the basis of an extensive explorative search, an appropriate algorithm for a systematic database search was developed. The following databases were searched: BIOSIS Previews, CRD databases, Cochrane Library, EconLit, Embase, Medline, and Web of Science. Only completed and published trial- or model-based studies which contained a full economic evaluation of growth factors and bioengineered skin substitutes for the treatment of chronic wounds were included. Two reviewers independently undertook the assessment of study quality. The relevant studies were assessed by a modified version of the Consensus on Health Economic Criteria (CHEC) list and a published checklist for evaluating model-based economic evaluations. Results Eleven health economic evaluations were included. Three biotechnology products were identified for which topical growth factors or bioengineered skin substitutes for the treatment of chronic leg ulceration were economically assessed: (1) Apligraf®, a bilayered living human skin equivalent indicated for the treatment of diabetic foot and venous leg ulcers (five studies); (2) Dermagraft®, a human fibroblast-derived dermal substitute, which is indicated only for use in the treatment of full-thickness diabetic foot ulcers (one study); (3) REGRANEX® Gel, a human platelet-derived growth factor for the treatment of deep neuropathic diabetic foot ulcers (five studies). The studies considered in this review were of varying and partly low methodological quality. They calculated that due to shorter treatment periods, fewer complications and fewer inpatient episodes the initial cost of the novel biotechnology products may be offset, making the treatment cost-effective or even cost-saving. The results of most studies were sensitive to initial costs of the products and the evidence of effectiveness. Conclusion The study results suggest that some growth factors and tissue-engineered artificial skin products feature favourable cost-effectiveness ratios in selected patient groups with chronic wounds. Despite the limitations of the studies considered, it is evident that health care providers and coverage decision makers should take not only the high cost of the biotechnology product but the total cost of care into account when deciding about the appropriate allocation of their financial resources. However, not only the cost-effectiveness but first of all the effectiveness of these novel biotechnology products deserve further research.
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              Evaluation and Management of Lower-Extremity Ulcers

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                Author and article information

                Journal
                Regen Med Res
                Regen Med Res
                rmr
                Regenerative Medicine Research
                EDP Sciences
                2050-490X
                2019
                10 December 2019
                : 7
                : ( publisher-idID: rmr/2019/01 )
                Affiliations
                [1 ] Department of Vascular Surgery, Hospital Henri Mondor, Université Paris-Est Créteil 94010 France
                [2 ] Department of Endocrinology, Hospital Henri Mondor, Université Paris-Est Créteil 94010 France
                [3 ] OTR3, SAS, 4 rue Française 75001 Paris France
                [4 ] CRRET (EA 4397/ERL CNRS 9215), Université Paris-Est Créteil 94010 France
                Author notes
                [* ]Corresponding author: denis.barritault@ 123456otr3.com
                Article
                rmr190002 10.1051/rmr/190002
                10.1051/rmr/190002
                6902838
                31821145
                © P. Desgranges et al., published by EDP Sciences, 2019

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                Page count
                Figures: 4, Tables: 2, Equations: 0, References: 19, Pages: 9
                Categories
                Original Article

                matrix therapy, cacipliq20, otr4120, ischemic skin ulcers

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