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DFU

Policy No.

2.01.17

States

Grafix Core Q4132

Covered – DFU/DLEU

Grafix PL/Prime Q4133

Not Covered

Educational resources

Placental Tissue Science & Therapeutic Applications

Educational Content, Resources, & Events

Accredited Wound Care Courses

Dhall S, Sathyamoorthy M, Kuang JQ, et al. Properties of viable lyopreserved amnion are equivalent to viable cryopreserved amnion with the convenience of ambient storage. Plos One. 2018; 13 (10): e0204060
Mamede AC, Carvalho, MJ, Abrantes AM, et al. Amniotic membrane: from structure and functions to clinical applications. Cell Tissue Res. 2012; 349 (2): 447-458
Sen CK, Gordillo GM, Roy S, et al. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009; 17(6): 763-771
Fife AC, Carter MJ, Walker D, et al. Wound care outcomes and associated cost among patients treated in the US outpatient wound centers: Data from the US Wound Registry. Wounds. 2012; 24 (1): 10-17
Greer N, Foman NA, MacDonald R, et al. Advanced wound care therapies for nonhealing diabetic, venous, and arterial ulcers: a systematic review. Ann Intern Med. 2013; 159 (8): 532-42
Lavery LA, Fulmer J, Shebetka KA, et al. The efficacy and safety of Grafix® for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial.Int Wound J.2014; 11(5): 554-560
Lavery LA, Fulmer J, Shebetka KA, Regulski M, Vayser D, Fried D, Kashefsky H, Owings TM, Nadarajah J, Hesp Z . Open-label Extension Phase of a Chronic Diabetic Foot Ulcer Multicenter, Controlled, Randomized Clinical Trial Using Cryopreserved Placental Membrane. Wounds 2018; 30 (9): 283-289
Frykberg RG, Gibbons GW, Walters JL, et al. A prospective, multicentre, open-label, single-arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and/or bone: positive clinical outcomes of viable cryopreserved human placental membrane. Int Wound J. 2017; 14 (3): 569-577
Farivar BS, Toursavadkohi S, Monahan TS, et al. Prospective study of cryopreserved placental tissue wound matrix in the management of chronic venous leg ulcers. J Vasc Surg Venous Lymphat Disord 2019; 7(2): 228-233
Ananian CE, Davis DR, Johnson EL, et al. Wound closure outcomes suggest clinical equivalency between lyopreserved and cryopreserved placental membranes containing viable cells. Adv Wound Care (New Rochelle). 2019; 8 (11): 546–554
Johnson E, Marshall J, Michael G. A comparative outcomes analysis evaluating clinical effectiveness in two different human placental membrane products for wound management. Wound Repair Regen. 2017; 25 (1): 145-149
Raspovic KM, Wukich DK, Naiman DQ, et al. Effectiveness of viable cryopreserved placental membranes for management of diabetic foot ulcers in a real-world setting. Wound Repair Regen. 2018; 26 (2): 213-220
Kirsner RS, Sabolinski ML, Parsons NB, Skornicki M, Marston WA. Comparative effectiveness of a bioengineered living cellular construct vs. a dehydrated human amniotic membrane allograft for the treatment of diabetic foot ulcers in a real world setting. Wound Repair Regen. 2015; 23 (5): 737-44
Marston WA, Sabolinski ML, Parsons NB, Kirsner RS. Comparative effectiveness of a bilayered living cellular construct and a porcine collagen wound dressing in the treatment of venous leg ulcers. Wound Repair Regen. 2014; 22 (3): 334-40
Regulski M, Jacobstein DA, Petranto RD, et al. A retrospective analysis of a human cellular repair matrix for the treatment of chronic wounds. Ostomy Wound Manage.2013; 59 (12): 38-43
Data on file at Osiris Therapeutics, Inc
DaVanzo J, Hartzman A, Surfield C, Dobson A. Cryopreserved placental membrane allograft reduces the likelihood of developing a new or recurring foot ulcer and all-cause mortality in diabetic patients, when compared to other cellular-and tissue-based products. Adv Wound Care. 2022 Apr 25.
Padula WV, Ramanathan S, Cohen BG. Comparative effectiveness of placental allografts in the treatment of diabetic lower extremity ulcers and venous leg ulcers in U.S. Medicare beneficiaries: a retrospective observational cohort study using real-world evidence. Advances in Wound Care. 2024 Mar 5.

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