TWO2
Erstellt am 13 Apr 2023 22:54
Zuletzt geändert: 17 Apr 2023 14:21
Leitlinien
- International Working Group of the Diabetic Foot - Guidelines: Neue Versionen der Leitlinien sollen auf dem "International Symposium on the Diabetic Foot" im Mai 2023 vorgestellt werden.
- Aktuell enthalten die "Wound healing interventions" Guidelines mit Stand 2019 noch folgende Empfehlung:
We suggest not using topical oxygen therapy as a primary or adjunctive intervention in diabetic foot ulcers including those that are difficult to heal. (Weak; Low)
- ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Gibbons CH, Giurini JM, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Sun JK, Gabbay RA, on behalf of the American Diabetes Association. 12. Retinopathy, Neuropathy, and Foot Care: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S203-S215. doi: 10.2337/dc23-S012. PMID: 36507636; PMCID: PMC9810462. (Volltext beim Publisher)
Studien, Literatur
- Carter MJ, Frykberg RG, Oropallo A, Sen CK, Armstrong DG, Nair HKR, Serena TE. Efficacy of Topical Wound Oxygen Therapy in Healing Chronic Diabetic Foot Ulcers: Systematic Review and Meta-Analysis. Adv Wound Care (New Rochelle). 2023 Apr;12(4):177-186. doi: 10.1089/wound.2022.0041. Epub 2022 Jun 21. PMID: 35593010; PMCID: PMC9885545.
- Pasek J, Szajkowski S, Travagli V, Cieślar G. Topical Hyperbaric Oxygen Therapy Versus Local Ozone Therapy in Healing of Venous Leg Ulcers. Int J Environ Res Public Health. 2023 Jan 20;20(3):1967. doi: 10.3390/ijerph20031967. PMID: 36767335; PMCID: PMC9915083.
- Yellin JI, Gaebler JA, Zhou FF, Niecko T, Novins O, Ockert A, Krzynowek D, Garoufalis MG, Lee AM, Frykberg RG. Reduced Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes. Adv Wound Care (New Rochelle). 2022 Dec;11(12):657-665. doi: 10.1089/wound.2021.0118. Epub 2021 Dec 6. PMID: 34714167; PMCID: PMC9527050.
- Sun XK, Li R, Yang XL, Yuan L. Efficacy and safety of topical oxygen therapy for diabetic foot ulcers: An updated systematic review and meta-analysis. Int Wound J. 2022 Dec;19(8):2200-2209. doi: 10.1111/iwj.13830. Epub 2022 May 5. PMID: 35510518; PMCID: PMC9705166.
- Vulakh GM, Hingorani AP, Ascher E, Marks N. Adjunctive topical oxygen therapy for wound healing in patients with peripheral arterial disease. Vascular. 2022 Mar 24:17085381221080270. doi: 10.1177/17085381221080270. Epub ahead of print. PMID: 35321603.
- Prospektive, nicht randomisierte Fallserie.
Conclusion: While these data are from a single-center and are single-armed, they represent the largest reported series of this therapy. This home-based therapy does show promise and warrants further investigation.
- Frykberg RG, Franks PJ, Edmonds M, Brantley JN, Téot L, Wild T, Garoufalis MG, Lee AM, Thompson JA, Reach G, Dove CR, Lachgar K, Grotemeyer D, Renton SC; TWO2 Study Group. A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study. Diabetes Care. 2020 Mar;43(3):616-624. doi: 10.2337/dc19-0476. Epub 2019 Oct 16. PMID: 31619393. (Volltext)
- Studie ist auch aufgeführt im Cochrane Central Register of Controlled Trials
- Löndahl M. Number Eight in the Service of Diabetic Foot Ulcer Healing. Diabetes Care. 2020 Mar;43(3):515-517. doi: 10.2337/dci19-0052. PMID: 32079686. (Begleitendes Editorial zur Publikation der TWO2 Studie; Volltext)
- Frykberg RG; TWO2 Study Group. Comment on Löndahl. Number Eight in the Service of Diabetic Foot Ulcer Healing. Diabetes Care 2020;43:515-517. Diabetes Care. 2020 Sep;43(9):e116-e117. doi: 10.2337/dc20-0729. PMID: 32910783; PMCID: PMC7440901. (Antwort der Autoren auf Methodenkritik in dem Editorial von Löndahl)
- Kaufman H, Gurevich M, Tamir E, Keren E, Alexander L, Hayes P. Topical oxygen therapy stimulates healing in difficult, chronic wounds: a tertiary centre experience. J Wound Care. 2018 Jul 2;27(7):426-433. doi: 10.12968/jowc.2018.27.7.426. PMID: 30016136.
- 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. Iran Red Crescent Med J. 2015 Nov 3;17(11):e20211. doi: 10.5812/ircmj.20211. PMID: 26734476; PMCID: PMC4698133.
Hersteller
- Advanced Oxygen Therapy Inc. (AOTI): AOTI offers single use Topical Wound Oxygen (TWO2) therapy products
- Pressemeldung über die Arbeitsaufnahme der Europäischen Unternehmenszentrale in Irland im Jahr 2007
- AOTI opens expanded manufacturing facility in Galway, Ireland NS Medical Devices, Meldung vom 09.08.2018.
Rezeption in Deutschland
- Spraul, M. Sauerstoff in der Drucktüte bei Fußulzera doch sinnvoll?. Info Diabetol 14, 18–19 (2020). https://doi.org/10.1007/s15034-020-2130-1
Gesundheitsökonomie, Versorgung
- Ansari TA, Barik S, Meena P, Arora S. Comparison of Topical Oxygen with Vacuum Assisted Closure in Wound Healing in a Low Resource Setting. Ethiop J Health Sci. 2022 Sep;32(5):955-962. doi: 10.4314/ejhs.v32i5.11. PMID: 36262707; PMCID: PMC9554766.
Cost-effectiveness is another major factor which has not been considered in this study. In the developing countries of Asia and Africa, this can be a game changer over which treatment method is preferred considering the fact that this study doesn't prove any of the method to be superior. Studies have focussed on the high costs involved in VAC and its inability to be used on a regular basis in countries where the poor socioeconomic status of the patient makes it difficult (12). Though numerous studies have been conducted which use low cost VAC devices, large scale multicentric prospective studies are lacking regarding its efficacy (13). TOT in comparison to VAC, is cost effective considering the components which are required for its use(14,15). A sterile sealant, like a C arm cover, as well as continuous oxygen supply are ubiquitous in any hospital catering to orthopaedic and plastic surgery patients. Cost benefit studies are planned to be conducted in a full-fledged manner on the basis of the results of this pilot study.
- Chan BC, Campbell KE. An economic evaluation examining the cost-effectiveness of continuous diffusion of oxygen therapy for individuals with diabetic foot ulcers. Int Wound J. 2020 Dec;17(6):1791-1808. doi: 10.1111/iwj.13468. Epub 2020 Jul 27. PMID: 33189100; PMCID: PMC7754389.
Sonstige Literatur
- Sumpio BJ, Mezghani I, Wang E, Li Z, Valsami EA, Theocharidis G, Veves A. Experimental treatments in clinical trials for diabetic foot ulcers: wound healers in the pipeline. Expert Opin Investig Drugs. 2023 Feb;32(2):95-99. doi: 10.1080/13543784.2023.2178418. Epub 2023 Feb 21. PMID: 36749693.
- Boulton AJM, Armstrong DG, Löndahl M, Frykberg RG, Game FL, Edmonds ME, Orgill DP, Kramer K, Gurtner GC, Januszyk M, Vileikyte L. New Evidence-Based Therapies for Complex Diabetic Foot Wounds. Arlington (VA): American Diabetes Association; 2022 May. PMID: 35763580. (Volltext)
- Connaghan F, Avsar P, Patton D, O'Connor T, Moore Z. Impact of topical oxygen therapy on diabetic foot ulcer healing rates: a systematic review. J Wound Care. 2021 Oct 2;30(10):823-829. doi: 10.12968/jowc.2021.30.10.823. PMID: 34644137.
- Nataraj M, Maiya AG, Karkada G, Hande M, Rodrigues GS, Shenoy R, Prasad SS. Application of Topical Oxygen Therapy in Healing Dynamics of Diabetic Foot Ulcers - A Systematic Review. Rev Diabet Stud. 2019;15:74-82. doi: 10.1900/RDS.2019.15.74. Epub 2019 Dec 30. PMID: 31904759; PMCID: PMC6946089.
- 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 Jan;47(1):30-7. doi: 10.1177/1538574412467684. Epub 2012 Dec 5. PMID: 23223182.
Abgrenzung hyperbare Sauerstofftherapie
- UHMS Position Statement: Topical Oxygen for Chronic Wounds. Undersea Hyperb Med. 2018 May-Jun;45(3):379-380. PMID: 30028926. DOI Number: 10.22462/05.06.2018.15. (UHMS-Volltext)
- Mutluoglu M, Cakkalkurt A, Uzun G, Aktas S. Topical Oxygen for Chronic Wounds: A PRO/CON Debate. J Am Coll Clin Wound Spec. 2014 Dec 19;5(3):61-5. doi: 10.1016/j.jccw.2014.12.003. PMID: 26199891; PMCID: PMC4495745.
- Mutluoglu M, Uzun G, Bennett M, Germonpré P, Smart D, Mathieu D. Poorly designed research does not help clarify the role of hyperbaric oxygen in the treatment of chronic diabetic foot ulcers. Diving Hyperb Med. 2016 Sep;46(3):133-134. PMID: 27723012.
- Handan O, Samil A. Hyperbaric oxygen and topical oxygen are different treatments. Indian J Plast Surg. 2015 May-Aug;48(2):216-7. doi: 10.4103/0970-0358.163069. PMID: 26424993; PMCID: PMC4564513.
- Feldmeier JJ, Hopf HW, Warriner RA 3rd, Fife CE, Gesell LB, Bennett M. UHMS position statement: topical oxygen for chronic wounds. Undersea Hyperb Med. 2005 May-Jun;32(3):157-68. PMID: 16119307.
- Cronjé FJ. Oxygen therapy and wound healing--topical oxygen is not hyperbaric oxygen therapy. S Afr Med J. 2005 Nov;95(11):840. PMID: 16344878.
- Piantadosi CA. Topical oxygen is not hyperbaric oxygen (HBO2). Undersea Hyperb Med. 2003 Winter;30(4):267-9. PMID: 14756228.
Gemeinsamer Bundesausschuss
- Gemeinsamer Bundesausschuss: Verbandmittel und sonstige Produkte zur Wundbehandlung
- Gemeinsamer Bundesausschuss: Antworten auf häufig gestellte Fragen zur Verordnungsfähigkeit von Medizinprodukten in der Arzneimittelversorgung
- Arzneimittel-Richtlinie: Anlage Va: Verbandmittel und sonstige Produkte zur Wundbehandlung
WebLinks, Sonstiges
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