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…
Guidelines for the use of topical oxygen therapy in the treatment of hard-to-heal wounds based on a Delphi consensus – Summary
Download Summary PDF Read Article on JWC
| Level of Evidence | Author (s) | Study | Year Published | Publication Site | Wound Type | Citation | |
|---|---|---|---|---|---|---|---|
| 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. View Site | 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. View Site | https://doi.org/10.1111/iwj.13468 |
| 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. Epub 2019 July 31. | |
| 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. | |
| 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: 1h0t.t1p1s:7//7d/o1i.9o3rg2/1209.6118717/1693525279468 | |
| 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.
