References

References From Results Page
Study:
  1. de Leon JM, Driver VR, Fylling CP, et al. The clinical relevance of treating chronic wounds with an enhanced near-physiological concentration of platelet-rich plasma gel. Adv Skin Wound Care. 2011; 24(8): 357–368.
††Study:
  1. Driver VR, Hanft J, Fylling CP, Beriou JM. AutoloGel Diabetic Foot Ulcer Study Group. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Ost Wound Manage. 2006; 52(6): 68–87.
††† Multiple Studies:
  1. Driver VR, Hanft J, Fylling CP, Beriou JM, AutoloGel Diabetic Foot Ulcer Study Group. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers Ost Wound Manage. 2006; 52(6): 68–87.
  2. Osiris FORM 10-Q for the quarterly period ended September 30, 2013.
  3. Veves A, Falanga V, Armstrong DG, Sabolinski, ML. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers. Diabetes Care. 2001; 24(2): 290–295.
  4. Steed DL. Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity diabetic foot ulcers. J of Vasc Surg. 1995; 21(1): 71-81.
  5. Marston WA, Hanft J, Norwood P, et al. The efficacy and safety of dermagraft in improving the healing of chronic diabetic foot ulcers. Diabetes Care. 2003; 26: 1701–1705.
AURIX/AUTOLOGEL CLINICAL CASE STUDY PUBLICATIONS
Prospective, Randomized, Blinded, Multi-Center, Controlled Trial
  1. Driver VR, Hanft J, Fylling CP, Beriou JM. AutoloGel Diabetic Foot Ulcer Study Group. A prospective, randomized, controlled trial of autologous platelet- rich plasma gel for the treatment of diabetic foot ulcers. Ost Wound Manage. 2006; 52(6): 68–87.
Comparison Studies: Run In Treatment vs AutoloGel Treatment
  1. Carter M, Fylling C, Li W, et al. A statistical analysis of a wound outcomes registry using run-in data: clinical impact of platelet-rich plasma gel on healing trajectory. Int Wound J. 2011; 8: 638–650.
  2. Sakata J, Sasaki S, Handa K, et al. A retrospective, longitudinal study to evaluate healing lower extremity wounds in patients with diabetes mellitus and ischemia using standard protocols of care and platelet-rich plasma gel in a Japanese wound care program. Ost Wound Manage. 2012; 58(4): 36–49.
Observational Studies (de Leon Article Includes Comparative Analysis)
  1. Frykberg RG, Driver VR, Carman D, et al. Chronic wounds treated with a physiologically relevant concentration of platelet-rich plasma gel: a prospective case series. Ost Wound Manage. 2010; 56(6): 36–44.
  2. Rappl LM. Effect of platelet-rich plasma gel in a physiologically relevant platelet concentration on wounds in persons with spinal cord injury. Int Wound J. 2011; 8(2): 187–195.
  3. de Leon J, Driver VR, Fylling CP, et al. The clinical relevance of treating chronic wounds with an enhanced near-physiological concentration of platelet-rich plasma gel. Adv Skin Wound Care. 2011; 24(8): 357–368.
Case Series
  1. Gurvich L. Synergism in using negative pressure wound therapy with alternated applications of autologous platelet-derived growth factors in treating post-acute surgical wounds. Wounds. 2009; 21(5): 134–140.
Cost Effectiveness
  1. Dougherty EJ. An evidence-based model comparing the cost-effectiveness of platelet-rich plasma gel to alternative therapies for patients with nonhealing diabetic foot ulcers. Adv Skin Wound Care. 2008; 21(12): 568–75.
Systematic Review of PRP Literature Which Includes AutoloGel PRP Gel
  1. Carter MJ, Fylling CP, Parnell LKS. Use of platelet-rich plasma gel on wound healing: a systematic review and meta-analysis. Eplasty. 2011; 11: 382-406.

References From Coverage Page

For more details on billing and reimbursement codes related to Aurix and the CED program please see Reimbursement Guide for Hospitals and Reimbursement Guide for Physician Offices.

†† For more information on indications and limitations of coverage, see the Centers for Medicare & Medicaid Services (CMS) analysis of National Coverage Determination (NCD) for Blood-Derived Products for Chronic Non-Healing Wounds.