Clinical Evidence
AOTI is committed to providing the strongest scientific evidence as to the Efficacy, Clinical and Quality Of Life benefits of our unique Topical Wound Oxygen (TWO2) therapy. The following table summarizes the already extensive published clinical evidence as to the utility of TWO2. Additionally, the company is in the process of conducting further clinical trials for different wound types, including a multi-centered, multi-national, placebo controlled, Randomized Controlled Trial of 220 patients, to further investigate the clinical outcomes and cost saving benefits of our therapy in non-healing Diabetic ulcer patients.
Author | Journal | Study Type | No. of Patients | Ulcer | Outcome |
Robert G. Frykberg, Peter J. Franks, Michael Edmonds, Jonathan N. Brantley, Luc Téot, Thomas Wild, Matthew G. Garoufalis, Aliza M. Lee, Janette A. Thompson, Gérard Reach, Cyaandi R. Dove, Karim Lachgar, Dirk Grotemeyer, Sophie C. Renton, on behalf of the TWO2 Study Group | Diabetes Care 2019 Oct; dc190476. | A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study | 73 | Diabetic | TWO2 was shown to be 6 times more likely to heal a DFU at 12 weeks compared to optimal SOC after adjusting for ulcer severity. TWO2 demonstrated more durable healing with a 6 times lower recurrence rate compared to optimal SOC with only 6.7% of Active TWO2 vs 40% of Sham TWO2 ulcers recurring at 12 months. Primary Endpoint of Ulcers 100% Healed at 12 Weeks: Active TWO2 = 41.7% vs Sham TWO2 = 13.5% Likely Healing Outcome at 12 Weeks: Odds ratio (OR) of 4.57 (97.8% CI 1.19, 17.57), P=0.010 After adjustment for University of Texas Classification (UTC) ulcer grade Odds ratio (OR) increased to 6.00 (97.8% CI 1.44, 24.93), P=0.004. The wound care–focused QOL index improved for patients whose ulcers healed with Active TWO2 in all functional domains, with the greatest improvement seen in the Well-Being component that improved 90-fold. For the patients with larger open ulcers at the end of the 12-week active phase, the mean reduction in ulcer area from baseline was 4.12 cm for Active TWO2 compared with a 1.34 cm increase for the Sham TWO2. |
Frykberg, R et al | Multi-National, Multi-Center, Prospective, Randomized, Double Blinded, Placebo-Controlled Trial | 73 | Diabetic | 41.7% of TWO2 treated ulcers were completely healed compared to just 13.5% of ulcers treated with gold standard-of-care alone at 12 weeks. | |
Tawfick, W et al | Vascular and Endovascular Surgery | Controlled | 132 | Venous | Mean reduction in ulcer surface area at 12 weeks was 96% with 76% of ulcers |
Blackman E et al | Ostomy Wound Management | Prospective Controlled Study | 28 | Diabetic | 82.4% of ulcers completely healed at 12 weeks |
Ichioka S et al | Wounds International | Case Series | 6 | Pressure & Diabetic | Improved ulcer healing |
Aburto et al | Journal of Wound | Randomized Controlled Trial | 40 | Diabetic & Venous | Diabetic ulcers 90% healing in 12 weeks |
Sultan S et al | European Journal of Vascular and Endovascular Surgery | Parallel study | 83 | Venous | 80% ulcers healed at 12 weeks |
Japour C et al | Desert Foot Conference Proceedings | Case Series | 5 | Diabetic | Average time to 100% closure was 3.4 months |
Derk F et al | Desert Foot Conference Proceedings | Case Series | 9 | Diabetic & Dehiscence | Average time to 100% closure was 12.7 weeks |
Levine B et al | Desert Foot Conference Proceedings | Case Series | 14 | Diabetic & Venous | Average time to 100% closure was 11.5 weeks |
Kallianen LK et al | Pathophysiology | Case series | 32 | Mixed | 75% closure rate. No side effects |
Edsberg LE et al | Ostomy and Wound Management | Randomized Controlled Trial | 8 | Pressure | Healing of all wounds |
Landau Z et al | Yale Journal Biology & Medicine | Prospective open study | 100 | Diabetic | 81% Healing |
Heng MC et al | Ostomy and Wound Management | Prospective Randomized study | 40 | Pressure | 90% closure rate |
Heng MC et al | Ostomy and Wound Management | Prospective Study | 15 | Pressure | Overall improvement in ulcer size over time |
Landau Z et al | Arch Orthopedic Trauma Surgery | Prospective study | 50 | Diabetic | 86% closure rate |
Heng MC et al | American Journal Dermatopatho. | Case series | 6 | Pressure | Some clinical improvement |
Ignacio DR et al | Journal American Podiatry Asso. | Case series | 15 | Mixed | 73% healing rate |
Heng MC et al | Archives Dermatology | Prospective non- randomized study | 6 | Necrotic Pressure | 100% healing in TOT group |
Diamond E et al | Journal American Podiatry Assoc | Case series | 11 | Mixed | 100% healing |
Olejniezak S | Medical Times | Meta-Analysis Self Control | 174 | Mixed | Very Effective/ Favorable Results |
Fischer BH | Journal Dermatological Surgery | Case series | 30 | Mixed | Overall positive results |
Fischer BH | Lancet | Case series | 52 | Mixed | Positive results |