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October 4, 2018

Topical Oxygen Request for Information Bibliography

Joint DME MAC Article

In the fall of 2017, the DME MACs posted a Request for Information (RFI) regarding topical oxygen therapy for wound care that ran from September 14 through October 30, 2017 (45 days). The DME MACs supplemented the RFI by conducting their own literature search, and received literature regarding continuous diffusion of oxygen (CDO) for the treatment of chronic wounds from one manufacturer outside of the RFI.

The results from these 3 sources yielded one-hundred and fifty-two unique documents. Correspondence, Agency documents (CMS and FDA) etc. were removed from the document set, leaving one-hundred and thirty-one unique items included in the bibliography. These materials dated from 2017 back to 1967. For clinical relevance, an article publication age limit of 10 years was used (i.e., years 2007 – 2017), yielding sixty-four items for consideration. After non-clinical articles were removed, thirty-six articles remained for analysis.

Clinical Studies

  1. Armstrong D. A Prospective, Randomized, Double Blind Multicenter Study Comparing Continuous Diffusion of Oxygen (CDO) to Standard Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers.; 2015.
  2. Azimian J, Dehghan Nayeri N, Pourkhaleghi E, Ansari M. Transdermal Wound Oxygen Therapy on Pressure Ulcer Healing: A Single-Blind Multi-Center Randomized Controlled Trial. Iranian Red Crescent Medical Journal. 2015;17(11). doi:10.5812/ircmj.20211
  3. Blackman E, Moore C, Hyatt J, Railton R, Frye C. Topical wound oxygen therapy in the treatment of severe diabetic foot ulcers: a prospective controlled study. Ostomy Wound Manage. 2010;56(6):24-31.
  4. Blume PA, Walters J, Payne W, Ayala J, Lantis J. Comparison of negative pressure wound therapy using vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: a multicenter randomized controlled trial. Diabetes Care. 2008;31(4):631-636. doi:10.2337/dc07-2196
  5. Copeland K, Purvis AR. A Retrospective Chart Review of Chronic Wound Patients Treated with Topical Oxygen Therapy. Advances in Wound Care. 2017;6(5):143-152. doi:10.1089/wound.2017.0729
  6. Couture, M. Does Continuous Diffusion Of Oxygen Have Potential In Chronic Diabetic Foot Ulcers? Podiatry Today. 2015;28(12).
  7. 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. Advances in skin & wound care. 2008;21(12):568–575.
  8. Driver VR, Reyzelman A, Kawalec J, French M. A Prospective, Randomized, Blinded, Controlled Trial Comparing Transdermal Continuous Oxygen Delivery to Moist Wound Therapy for the Treatment of Diabetic Foot Ulcers. Ostomy/wound management. 2017;63(4):12.
  9. Driver VR, Yao M, Kantarci A, Gu G, Park N, Hasturk H. A prospective, randomized clinical study evaluating the effect of transdermal continuous oxygen therapy on biological processes and foot ulcer healing in persons with diabetes mellitus. Ostomy Wound Manage. 2013;59(11):19–26.
  10. Edmonds M, European and Australian Apligraf Diabetic Foot Ulcer Study Group. Apligraf in the Treatment of Neuropathic Diabetic Foot Ulcers. The International Journal of Lower Extremity Wounds. 2009;8(1):11-18. doi:10.1177/1534734609331597
  11. Gayle M Gordillo, Sashwati Roy, Savita Khanna, et.al. Topical Oxygen Therapy Induces VEGF Expression and Improves Closure of Clinically Presented Chronic Wounds. Clin Exp Pharmacol Physiol. 35(8) 2008
  12. Mujahid MD, Iqbal MS, Riaz O, Hameed F, Hussain R. Role of Adjuvant Topical Oxygen Therapy (Topox) Versus Conventional Methods in The Management of Non-Healing Infected Wounds. 2010. http://applications.emro.who.int/imemrf/Ann_Punjab_Med_Coll/Ann_Punjab_Med_Coll_2010_4_2_95_100.pdf. Accessed May 3, 2017.
  13. Nie K, Li P, Zeng X, et al. Clinical observation of basic fibroblast growth factor combined with topical oxygen therapy in enhancing burn wound healing. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2010;24(6):643-646.
  14. Niederauer MQ, Michalek JE, Armstrong DG. Interim results for a prospective, randomized, double-blind multicenter study comparing continuous diffusion of oxygen therapy to standard moist wound therapy in the treatment of diabetic foot ulcers. Wound Medicine. 2015;8:19-23. doi:10.1016/j.wndm.2015.03.005
  15. Niederauer MQ, Michalek JE, Armstrong DG. A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen Therapy to Sham Therapy in the Treatment of Diabetic Foot Ulcers. Journal of Diabetes Science and Technology. 2017;11(5):883-891. doi:10.1177/1932296817695574
  16. Patel C. Topicol Oxygen Theropy qs qn Adjunct in Complex Wound Cqre. unpublished. 2009.
  17. Quan SY, Lazarus GS, Kohli AR, Kapoor R, Margolis DJ. Digital Imaging of Wounds: Are Measurements Reproducible Among Observers? The International Journal of Lower Extremity Wounds. 2007;6(4):245-248. doi:10.1177/1534734607306880
  18. Tawfick W, Sultan S. Does Topical Wound Oxygen (TWO2) Offer an Improved Outcome Over Conventional Compression Dressings (CCD) in the Management of Refractory Venous Ulcers (RVU)? A Parallel Observational Comparative Study. European Journal of Vascular and Endovascular Surgery. 2009;38(1):125-132. doi:10.1016/j.ejvs.2009.03.027
  19. Tawfick WA, Sultan S. Technical and clinical outcome of topical wound oxygen in comparison to conventional compression dressings in the management of refractory nonhealing venous ulcers. Vasc Endovascular Surg. 2013;47(1):30-37. doi:10.1177/1538574412467684
  20. Winfeld B. Topical Oxygen and Hyperbaric Oxygen Therapy Use and Healing Rates in Diabetic Foot Ulcers. Wounds: a compendium of clinical research and practice. 2014;26:E39-E47.
  21. Woo KY, Coutts PM, Sibbald RG. Continuous topical oxygen for the treatment of chronic wounds: a pilot study. Advances in skin & wound care. 2012;25(12):543–547.
  22. Yu J, Lu S, McLaren A-M, Perry JA, Cross KM. Topical oxygen therapy results in complete wound healing in diabetic foot ulcers: Natrox heals diabetic foot ulcers. Wound Repair and Regeneration. 2016;24(6):1066-1072. doi:10.1111/wrr.12490

Public Health

  1. MacKenzie EJ. Health-Care Costs Associated with Amputation or Reconstruction of a Limb-Threatening Injury. The Journal of Bone and Joint Surgery (American). 2007;89(8):1685. doi:10.2106/JBJS.F.01350
  2. Margolis DJ, Malay DS, Hoffstad OJ, et al. Economic burden of diabetic foot ulcers and amputations. 2011. https://www.ncbi.nlm.nih.gov/books/NBK65152. Accessed August 28, 2017.
  3. Sen CK, Gordillo GM, Roy S, et al. Human skin wounds: A major and snowballing threat to public health and the economy. Wound Repair and Regeneration. 2009;17(6):763-771. doi:10.1111/j.1524-475X.2009.00543.x

Review Articles

  1. Brimson CH, Nigam Y. The role of oxygen-associated therapies for the healing of chronic wounds, particularly in patients with diabetes: Oxygen-associated therapies for the healing of wounds. Journal of the European Academy of Dermatology and Venereology. 2013;27(4):411-418. doi:10.1111/j.1468-3083.2012.04650.x
  2. Dissemond J, Kröger K, Storck M, Risse A, Engels P. Topical oxygen wound therapies for chronic wounds: a review. Journal of Wound Care. 2015;24(2):53-63. doi:10.12968/jowc.2015.24.2.53
  3. Eisenbud DE. Oxygen in Wound Healing. Clinics in Plastic Surgery. 2012;39(3):293-310. doi:10.1016/j.cps.2012.05.001
  4. Gordillo GM, Sen CK. Evidence-Based Recommendations for the Use of Topical Oxygen Therapy in the Treatment of Lower Extremity Wounds. The International Journal of Lower Extremity Wounds. 2009;8(2):105-111. doi:10.1177/1534734609335149
  5. Gotrupp F, Dissemond J, Baines C, Frykberg R, Jensen PO, Kot J, Kroger K,Longobardi P. Use of Oxygen Therapies in Wound Healing - Focus on Topical and Hyperbaric Oxygen Treatment. Journal of Wound Care 2017;26:S2-S42.
  6. Guo S, DiPietro LA. Factors Affecting Wound Healing. Journal of Dental Research. 2010;89(3):219-229. doi:10.1177/0022034509359125
  7. Howard MA, Asmis R, Evans KK, Mustoe TA. Oxygen and wound care: A review of current therapeutic modalities and future direction: Oxygen therapeutic modality review. Wound Repair and Regeneration. 2013;21(4):503-511. doi:10.1111/wrr.12069
  8. Ladizinsky D, Roe D. New insights into oxygen therapy for wound healing. Wounds. 2010;22(12):294-300.
  9. Mutluoglu M, Cakkalkurt A, Uzun G, Aktas S. Topical Oxygen for Chronic Wounds: A PRO/CON Debate. Journal of the American College of Clinical Wound Specialists. 2013;5(3):61-65. doi:10.1016/j.jccw.2014.12.003
  10. Orsted HL, Poulson R, Baum J, et al. Evidence-based practice standards for the use of topical pressurised oxygen therapy. International wound journal. 2012;9(3):271–284.
  11. Singer AJ, Tassiopoulos A, Kirsner RS. Evaluation and Management of Lower-Extremity Ulcers. Campion EW, ed. New England Journal of Medicine. 2017;377(16):1559-1567. doi:10.1056/NEJMra1615243

Publication History

Publication Date: October 4, 2018
Originally Published

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