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Clinical Evidence

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

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.

https://doi.org/10.2337/dc19-0476

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%
(Pearson Chi2 = 7.27, P = 0.007).

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

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