Clinical Evidence - Advanced Oxygen Therapy Inc.

Controlled Studies & Case Studies

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.

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Author	Journal	Study Type	No. of Patients	Ulcer Type	Outcome
Frykberg, R et al	American Diabetes Association’s 78th Scientific SessionsLate Breaking Abstract Diabetes, June 2018 Volume 67, Supp 1	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. TWO2 showed nearly 4 times the likelihood to completely heal ulcers compared to gold standard-of-care alone.
Tawfick, W et al	Vascular and Endovascular Surgery	Controlled Cohort Study	132	Venous	Mean reduction in ulcer surface area at 12 weeks was 96% with 76% of ulcers completely healed Median time to full healing was 57 days 6% ulcer reoccurrence after 36 months follow-up
Blackman E et al	Ostomy Wound Management	Prospective Controlled Study	28	Diabetic	82.4% of ulcers completely healed at 12 weeks Median time to full healing was 56 days No ulcer reoccurrence after 24 months follow-up
Ichioka S et al	Wounds International	Case Series	6	Pressure & Diabetic	Improved ulcer healing Increased the oxygen values of peri-wound area
Aburto et al	Journal of Wound Technology	Randomized Controlled Trial	40	Diabetic & Venous	Diabetic ulcers 90% healing in 12 weeks Venous ulcers 50% healed in 12 weeks
Sultan S et al	European Journal of Vascular and Endovascular Surgery	Parallel study	83	Venous	80% ulcers healed at 12 weeks Median time to full healing was 45 days No ulcer reoccurrence after 12 months follow-up Pain score improved from 8 to 3 by day 13
Japour C et al	Desert Foot Conference Proceedings	Case Series	5	Diabetic	Average time to 100% closure was 3.4 months Average number of treatments to closure was 45
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 Average number of treatments to closure was 33
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