Clinical Research
Clinical Efficacy
Proven Clinical Results – Unique Study Design
- Fully blinded with sham device (Placebo) as control arm
- Eliminated Placebo Effect – Patients and Clinicians did not know treatment arm
- Highest Level of Clinical Evidence – Level 1A (Double Blind with Placebo)
Statistically Significant Outcomes in 12 Weeks
- CDO leads to significantly higher rates of closure (2x to 4.6x)
- CDO works better in more chronic, larger and weight-bearing wounds
- CDO resulted in significantly faster time to closure (P<0.001)
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- Debridement significantly improves CDO outcomes
How Oxygen Works In Wound Healing
Increases Cell Metabolism & Energy
Continuous Pure Oxygen boosts vitality to support increased demand during healing
2-16
Faster Cell Growth & Wound Closure
- Increased collagen deposition (faster repair) 17-29,59
- Up to 70% faster endothelial gap closure rate
Rapid Pain Relief
- Over half of patients experience >75% reduction within 4 days 28-32
- Significant pain relief in a variety of wounds
Greater Wound Perfusion
Rate of angiogenesis proportional to oxygen concentration
33-40
Enhances Bodies Own Anti-Bacterial Capacity
Create Reactive Oxygen Species (i.e. Hydrogen Peroxide)
19,41-49,51
Better Strength & Appearance
- Higher tensile strength (reduced recurrence) 50-61
- Better collagen organization (reduced scarring)
Read more about How Oxygen Works In Wound Healing
Publications
Recommendations
Wound Healing Society DFU Treatment Guidelines Recommended topical oxygen as a Level 1 treatment recommendation “Topical oxygen has been shown…
Cost-Effectiveness of Continuously Diffused Oxygen Therapy Compared with Negative-Pressure Wound Therapy
Background: Continuous diffusion of oxygen (CDO) to wounds has demonstrated better effectiveness in healing wounds than negative-pressure wound therapy (NPWT).…
CDO Shown to be Highly Efficacious Across All Wound Types
The purpose of this analysis is to report on the clinical efficacy of Continuous Diffusion of Oxygen (CDO) therapy in…
| Level of Evidence | Author (s) | Study | Year Published | Publication Site | Wound Type | Citation |
|---|---|---|---|---|---|---|
| 2A | Mercurio M, Lavery LA, Agarwal A, Oropallo A | Cost-Effectiveness of Continuously Diffused Oxygen Therapy Compared with Negative-Pressure Wound Therapy | 2026 | Journal of Health Economics & Outcomes Research | Various | Mercurio M, Lavery LA, Agarwal A, Oropallo A. Cost-Effectiveness of Continuously Diffused Oxygen Therapy Compared with Negative-Pressure Wound Therapy. JHEOR. 2026;13(1):30-38. doi:10.36469/001c.155760 |
| 2A | Mercurio M, Lavery LA, Agarwal A, Oropallo A | Clinical Efficacy of Continuously Diffused Oxygen (CDO) Therapy and Cohort Comparison to Negative Pressure Wound Therapy (NPWT) | 2025 | Oxygen | Various | Mercurio M, Lavery LA, Agarwal A, Oropallo A. Clinical Efficacy of Continuously Diffused Oxygen (CDO) Therapy and Cohort Comparison to Negative Pressure Wound Therapy (NPWT). Oxygen 2025, 5(4), 26; https://doi.org/10.3390/oxygen5040026. |
| Guidance | Continuous Diffused Oxygen Therapy for Wound Healing | 2024 | Canadian Journal of Health Technologies | Various | Continuous Diffused Oxygen Therapy for Wound Healing. Canadian Journal of Health Technologies. Vol. 4 No. 9 (2024): September. https://doi.org/10.51731/cjht.2024.978 | |
| Meta-Analysis | Putri IL, Alyssa A, Aisyah IF, Permatasari AAIY, Pramanasari R, Wungu CDK | The efficacy of topical oxygen therapy for wound healing: A meta-analysis of randomized controlled trials and observational studies | 2024 | International Wound Journal | Various | Putri IL, Alyssa A, Aisyah IF, Permatasari AAIY, Pramanasari R, Wungu CDK. The efficacy of topical oxygen therapy for wound healing: A meta-analysis of randomized controlled trials and observational studies. Int Wound J. 2024; 21(7):e14960. doi:10.1111/iwj.14960 |
| Guidance | Lavery, L. A., Suludere, M. A., Attinger, C. E., Malone, M., Kang, G. E., Crisologo, P. A., Peters, E. J., & Rogers, L. C. | WHS (Wound Healing Society) guidelines update: Diabetic foot ulcer treatment guidelines | 2023 | Wound Repair and Regeneration | DFU | Lavery, L. A., Suludere, M. A., Attinger, C. E., Malone, M., Kang, G. E., Crisologo, P. A., Peters, E. J., & Rogers, L. C. (2023). WHS (Wound Healing Society) guidelines update: Diabetic foot ulcer treatment guidelines. Wound repair and regeneration. Advance online publication. https://doi.org/10.1111/wrr.13133 |
| Meta-Analysis | Carter MJ, Frykberg RG, Oropallo A, Sen CK, Armstrong DG, Nair HKR, et al. | Efficacy of Topical Wound Oxygen Therapy in Healing Chronic Diabetic Foot Ulcers: Systematic Review and Meta-Analysis. Advances in Wound Care | 2023 | Advances in Wound Care | DFU | Carter MJ, Frykberg RG, Oropallo A, Sen CK, Armstrong DG, Nair HKR, et al. Efficacy of Topical Wound Oxygen Therapy in Healing Chronic Diabetic Foot Ulcers: Systematic Review and Meta-Analysis. Advances in Wound Care. Apr 2023.177-186. http://doi.org/10.1089/wound.2022.0041 |
| Meta-Analysis | Sethi A, Khambhayta Y,Vas P. | Topical oxygen therapy for healing diabetic foot ulcers: a systematic review and meta-analysis of randomised control trials | 2023 | Health Sciences Review | DFU | Sethi A, Khambhayta Y,Vas P. Topical oxygen therapy for healing diabetic foot ulcers: a systematic review and meta-analysis of randomised control trials. Health Sciences Review; 2022;3:100028. https://doi.org/10.1016/j.hsr.2022.100028 |
| Guidance | Frykberg R, Andersen C, Chadwick P et al. | Use of Topical Oxygen Therapy in Wound Healing – International Consensus Document | 2023 | Journal of Wound Care | Various | Frykberg R, Andersen C, Chadwick P et al. Use of Topical Oxygen Therapy in Wound Healing – International Consensus Document. J Wound Care 2023:32 (Suppl. 8b) https://www.magonlinelibrary.com/pb-assets/JOWC/Oxygen-Consensus-23-7-31-1692271196447.pdf |
| Guidance | Chen P, Vilorio NC, Dhatariya K et al. | Guidelines on interventions to enhance healing of foot ulcers in people with diabetes | 2023 | Diabetes Metabolic Research Review | DFU | Chen P, Vilorio NC, Dhatariya K et al. Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update). Diabetes Metab Res Rev. 2023;e3644. https://doi.org/10.1002/dmrr.3644 |
| Guidance | AWCS Open Letter to CMS | 2023 | Open Letter | Various | AWCS Open Letter to CMS, May 2023. https://www.woundcarestakeholders.org/advocacy/submitted-comments/letter-to-cms-regarding-alliance-reconsideration-request-to-topical-oxygen-therapy-lcd | |
| Guidance | Nuha A. ElSayed, Grazia Aleppo, Vanita R. Aroda, Raveendhara R. Bannuru, Florence M. Brown, Dennis Bruemmer, Billy S. Collins, Christopher H. Gibbons, John M. Giurini, Marisa E. Hilliard, Diana Isaacs, Eric L. Johnson, Scott Kahan, Kamlesh Khunti, Jose Leon, Sarah K. Lyons, Mary Lou Perry, Priya Prahalad, Richard E. Pratley, Jane Jeffrie Seley, Robert C. Stanton, Jennifer K. Sun, Robert A. Gabbay | Retinopathy, Neuropathy, and Foot Care: Standards of Care in Diabetes—2023 | 2023 | Diabetes Care | Various | Nuha A. ElSayed, Grazia Aleppo, Vanita R. Aroda, Raveendhara R. Bannuru, Florence M. Brown, Dennis Bruemmer, Billy S. Collins, Christopher H. Gibbons, John M. Giurini, Marisa E. Hilliard, Diana Isaacs, Eric L. Johnson, Scott Kahan, Kamlesh Khunti, Jose Leon, Sarah K. Lyons, Mary Lou Perry, Priya Prahalad, Richard E. Pratley, Jane Jeffrie Seley, Robert C. Stanton, Jennifer K. Sun, Robert A. Gabbay; on behalf of the American Diabetes Association, 12. Retinopathy, Neuropathy, and Foot Care: Standards of Care in Diabetes—2023. Diabetes Care 1 January 2023; 46 (Supplement_1): S203–S215. https://doi.org/10.2337/dc23-S012 |
| 1C | Zulbaran-Rojas A, Bara RO, Lee M, Flores-Camargo A, Mishra R, Winocour S, Thompson A, Najafi B | Optimizing Tissue Oxygenation in Reduction Mammoplasty: The Role of Continuous Diffusion of Oxygen: A Feasibility Pilot Randomized Controlled Trial | 2023 | Journal of Surgical Research | Surgical | Zulbaran-Rojas A, Bara RO, Lee M, Flores-Camargo A, Mishra R, Winocour S, Thompson A, Najafi B. Optimizing Tissue Oxygenation in Reduction Mammoplasty: The Role of Continuous Diffusion of Oxygen: A Feasibility Pilot Randomized Controlled Trial. J Surg Res. 2023 Dec;292:113-122. doi: 10.1016/j.jss.2023.07.035. Epub 2023 Aug 21. PMID: 37611440. |
| Meta-Analysis | 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 | 2022 | International Wound Journal | DFU | 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. http://doi.org/10.1111/iwj.13830 |
| Guidance | Boulton AJM, Armstrong DG, Löndahl M, et al. | New Evidence-Based Therapies for Complex Diabetic Foot Wounds | 2022 | American Diabetes Association | Various | Boulton AJM, Armstrong DG, Löndahl M, et al. New Evidence-Based Therapies for Complex Diabetic Foot Wounds. Arlington (VA): American Diabetes Association; 2022 May. https://www.ncbi.nlm.nih.gov/books/NBK581559/ |
| Guidance | Serena T, Andersen C, Cole W, Garoufalis M, Frykberg R, Simman R. | Guidelines for the use of topical oxygen therapy in the treatment of hard-to-heal wounds based on a Delphi consensus | 2022 | Journal of Wound Care | Various | Serena T, Andersen C, Cole W, Garoufalis M, Frykberg R, Simman R. Guidelines for the use of topical oxygen therapy in the treatment of hard-to-heal wounds based on a Delphi consensus. J Wound Care 2022 31(3)):S20-S24. DOI: 10.12968/jowc.2022.31.Sup3.S20 |
| Meta-Analysis | Thanigaimani S, Singh T, Golledge J. | Topical oxygen therapy for diabetes-related foot ulcers: A systematic review and meta-analysis | 2021 | Diabetic Medicine | DFU | Thanigaimani S, Singh T, Golledge J. Topical oxygen therapy for diabetes-related foot ulcers: A systematic review and meta-analysis. Diabet Med. 2021 Aug;38(8):e14585. https://doi.org/10.1111/dme.14585 |
| 1C | Zulbaran-Rojas A, Mishra R, Pham A, Suliburk J, Najafi B | Continuous Diffusion of Oxygen Adjunct Therapy to Improve Scar Reduction After Cervicotomy - A Proof of Concept Randomized Controlled Trial | 2021 | Journal of Surgical Research | Surgical | Zulbaran-Rojas A, Mishra R, Pham A, Suliburk J, Najafi B. Continuous Diffusion of Oxygen Adjunct Therapy to Improve Scar Reduction After Cervicotomy - A Proof of Concept Randomized Controlled Trial. J Surg Res. 2021 Dec;268:585-594. doi: 10.1016/j.jss.2021.07.028. Epub 2021 Aug 29. PMID: 34469858. |
| 4A | Serena T, Andersen CA, Cole W, Garoufalis M, Frykberg R | Guidelines for the use of topical oxygen therapy in the treatment of hard-to-heal wounds based on a Delphi consensus | 2021 | Journal of Wound Care | Various | Serena, Andersen, Cole et al, Guidelines for the use of topical oxygen therapy in the treatment of hard-to-heal wounds based on a Delphi consensus, JWC Sept 2021 |
| 1C | Oropallo A, Serena T, Armstrong DG, Niederauer MQ | Molecular Biomarkers of Oxygen Therapy in Patients with Diabetic Foot Ulcers | 2021 | Biomolecules | Various | Oropallo AR, Serena TE, Armstrong DG, Niederauer MQ. Molecular Biomarkers of Oxygen therapy in Patients with Diabetic Foot Ulcers. Biomolecules 2021, 11, 925. https://doi.org/ 10.3390/biom11070925 |
| 1C | Oropallo A, Andersen CA | Topical Oxygen | 2021 | StatPearls | Various | Oropallo A, Andersen CA, Topical Oxygen, StatPearls 2021, NCBI Bookshelf ID NBK574579, PMID 34662093 |
| 4A | Andersen C | Topical oxygen therapy—hocus pocus or science? | 2021 | Journal of Wound Care | Various | Andersen C. Topical oxygen therapy—hocus pocus or science? jowc.2021.30.sup5.s6, May 2021. https://doi.org/10.12968/jowc.2021.30.Sup5.S6 |
| 4A | Niederauer MQ | How Can We Deliver Oxygen to Wounds? | 2021 | Journal of Wound Care | Various | Niederauer MQ. How can we deliver oxygen to wounds? jowc.2021.30.sup5.s3 May 2021. https://doi.org/10.12968/jowc.2021.30.Sup5.S3 |
| 1C | Zulbaran-Rojas A, Mishra R, Pham A, Suliburk J, Najafi B | Continuous Diffusion of Oxygen Adjunct Therapy to Improve Scar Reduction after Cervicotomy – A Proof of Concept Randomized Controlled Trial | 2021 | Journal of Surgical Research | Surgical | Zulbaran-Rojas A, Mishra R, Pham A, Suliburk J, Najafi B. Continuous Diffusion of Oxygen Adjunct Therapy to Improve Scar Reduction after Cervicotomy – A Proof of Concept Randomized Controlled Trial. J Surg Res 268:585-594 2021. DOI: https://doi.org/10.1016/j.jss.2021.07.028 |
| 1C | Lavery LA, Killeen AL, Farrar D, Akgul Y, Crisologo PA, Malone M, Davis KE | The effect of continuous diffusion of oxygen treatment on cytokines, perfusion, bacterial load, and healing in patients with diabetic foot ulcers | 2020 | International Wound Journal | Various | Lavery LA, Killeen AL, Farrar D, Akgul Y, Crisologo PA, Malone M, Davis KE. The effect of continuous diffusion of oxygen treatment on cytokines, perfusion, bacterial load, and healing in patients with diabetic foot ulcers. Int Wound J. 2020;1–10. https://doi.org/10.1111/iwj.13490 |
| 1C | Chan BCF, Campbell, KE | An Economic Evaluation Examining the Cost‐effectiveness of Continuous Diffusion of Oxygen Therapy for Individuals with Diabetic Foot Ulcers | 2020 | International Wound Journal | DFU | Chan BCF, 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;1–18. https://doi.org/10.1111/iwj.13468 |
| 1C | Zulbaran A, Rodriquez N, Golafshan S, Lepow B, Ross J, Najafi B | Effectiveness of CDO Therapy to Improve Success Rate of Lower Extremity Surgically Closed Wound | 2020 | 8th Annual Michael E DeBakey Dept Surgery Research Day | Surgical | POSTER- Zulbaran et al, Effectiveness of CDO Therapy to Improve Success Rate of Lower Extremity Surgically Closed Wound, 8th Annual Michael E DeBakey Dept Surgery Research Day, Baylor, 2020-06-03 |
| 1C | Zulbaran A, Rodriquez N, Mishra RK, Elizondo H, Kahn A, Golafshan S, Suliburk J, Najafi B | Effectiveness of CDO Adjunct Therapy to Improve Scar Reduction after Anterior Neck Surgery | 2020 | 8th Annual Michael E DeBakey Dept Surgery Research Day | Surgical | POSTER- Zulbaran et al, Effectiveness of CDO Adjunct Therapy to Improve Scar Reduction after Anterior Neck Surgery, 8th Annual Michael E DeBakey Dept Surgery Research Day, Baylor, 2020-06-03 |
| 3A | Urrea-Botero G, Neri-Hernandez R | Utilizing Variable Flow Rate Continuous Diffusion of Oxygen* (CDO) to Modulate Exudate and Iterate Pain in Chronic Wounds | 2020 | SAWC Fall 2020 | Various | POSTER- Urrea-Botero & Neri-Hernandez, Utilizing Varible Flow Rate Continuous Diffusion of Oxygen to Modulate Exudate and Iterate Pain in Chronic Wounds, Gonzaba 2020 |
| 4A | Kimmel HM | A Comparison of Continuous Oxygen Therapy to Topical Oxygen | 2019 | Foot & Ankle Quarterly | Various | Kimmel HM, A Comparison of Continuous Oxygen Therapy to Topical Oxygen, Foot & Ankle Quarterly, Winter 2019, 30(4) 203-209 |
| 1A | Lavery LA, Niederauer MQ, Papas KK, Armstrong DG | Does Debridement Improve Clinical Outcoes in People with DFU Ulcers Treated with CDO? | 2019 | Wounds | DFU | Lavery LA, Niederauer MQ, Papas KK, Armstrong DG, Does Debridement Improve Clinical Outcomes in People with DFU Ulcers Treated with CDO? Wounds 31(10):246-251 2019. PMID: 31461400 |
| 1A | Niederauer MQ | Conference Report-Skin Integrity and Infection Prevention Las Vegas: continuous delivery of oxygen enhances closure of diabetic foot ulcers | 2018 | Journal of Wound Care | DFU | Niederauer MQ, Conference Report-Skin Integrity and Infection Prevention Las Vegas: continuous delivery of oxygen enhances closure of diabetic foot ulcers, J Wound Care 2018(27)12,856-7 |
| 1A | Niederauer MQ, Michalek JE, Liu Q, Papas, Lavery LA, Armstrong DG | Continuous Diffusion of Oxygen Improves Diabetic Foot Ulcer Healing When Compared with a Placebo Control: a Randomised, double-blind, multicentre study | 2018 | Journal of Wound Care | DFU | Niederauer MQ, Michalek JE, Liu Q, Papas, Lavery LA, Armstrong DG. Continuous diffusion of oxygen improves diabetic foot ulcer healing when compared with a placebo control: a randomised, double-blind, multicentre study. J Wound Care 27(9):s30-s45 2018. https://doi.org/10.12968/jowc.2018.27.Sup9.S30 |
| 2A | Bowen J, Ingersoll MS, Carlson R | Effect of CDO on Pain in Treatment of Chronic Wounds | 2018 | Wound Central | Various | Bowen J, Ingersoll MS, Carlson R. Effect of CDO on Pain in Treatment of Chronic Wounds. Wound Central 2(4);186-195 2018. |
| 1A | 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 | 2017 | Journal of Diabetes Science & Technology | DFU | 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. J Diabetes Science Tech. 2017, Special Issue, 1-9. DOI: 10.1177/1932296817695574 |
| 1A | 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. | 2015 | Wound Medicine | DFU | 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 8:19-23, 2015. |
| 2A | Couture M | Does Continuous Diffusion of Oxygen Have Potential in Chronic Diabetic Foot Ulcers? | 2015 | Podiatry Today | DFU | Couture M. Does Continuous Diffusion Of Oxygen Have Potential In Chronic Diabetic Foot Ulcers? Podiatry Today 28(12) 2015. |
| 2A | Urrea-Botero G | Can Continuous Diffusion of Oxygen Heal Chronic Toe Ulcers? | 2015 | Podiatry Today | Toe Ulcers | Urrea-Botero G. Can Continuous Diffusion of Oxygen Heal Chronic Toe Ulcers? Podiatry Today 28(10) 2015. |
| 3B | Brannick B, Engelthaler M, Jadzak J, Wu S | A Closer Look at Continuous Diffusion of Oxygen Therapy for a Chronic, Painful Venous Leg Ulcer | 2014 | Podiatry Today | Various | Brannick B, Engelthaler M, Jadzak J, Wu S. A Closer Look at Continuous Diffusion of Oxygen Therapy for a Chronic, Painful Venous Leg Ulcer. Podiatry Today 27(11) 2014. |
| 4A | Howard MA, Asmis R, Evans KK, Mustoe TA | Oxygen and wound care- A review of current therapeutic modalities and future direction | 2013 | Wound Repair and Regeneration | Various | Howard MA, Asmis R, Evans KK, Mustoe TA. Oxygen and wound care- A review of current therapeutic modalities and future direction. Wound Rep Reg. 2013; 21(4):503-511. |
| 4B | Asmis R, Qiao M, Zhao Q | Low-Flow Oxygenation of Full-Excisional Skin Wounds on Diabetic Mice Improves Wound Healing by Accelerating Wound Closure and Reepithelialization | 2010 | International Wound Journal | Preclinical | Asmis R, Qiao M, Zhao Q. Low-Flow Oxygenation of Full-Excisional Skin Wounds on Diabetic Mice Improves Wound Healing by Accelerating Wound Closure and Reepithelialization. Int Wound J 2010 ; 7: 349-357. |
| 3B | Various | Case Reports on Variety of Wounds | Various | eo2.com | Various | N/A |
Case Studies
Outcome: Wound Closed
Days on Service: 47
Outcome: Wound Healed
Days on Service: 81
Outcome: Wound healed
Days on Service: 55
Outcome: 99% Closure
Days on Service: 93
EO2 Concepts® is an ISO 13485:2016 certified company that maintains a Canadian Medical Device License for distribution of innovative wound care products throughout the United States and Canada.
