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Clinical Studies
Clinical Studies, Case Series & Abstracts
AOTI is committed to providing the strongest scientific evidence as to the therapeutic benefits of our unique two2™ therapy. The following table and links detail the already extensive published evidence as to the utility of Topical Wound Oxygen. Additionally, the company is sponsoring three separate Randomized Controlled Trials encompassing over 250 patients, that are specifically investigating the clinical outcomes and cost saving benefits of our therapy in both Diabetic and Venous ulcer patients.  These studies are either ongoing or awaiting publication in leading journals.
Author
Journal
Study Type
No. of Patients
Ulcer Type
Outcome
W. Tawfick,
S. Sultan
European Journal of Vascular and Endovascular Surgery
Parallel study
83
Venous
90% Healed
Sultan S et al
Irish Journal of Medical Science
Parallel study
60
Venous
90% Healing
Dutton L et al
Canada Wound Care Society Mtg.
Case Study
1
Diabetic
Effective in healing difficult wounds
Kallianen LK et al
Pathophysiology
Case series
32
Mixed
75% closure rate. No side effects
Edsberg LE et al
Ostomy and Wound Management
Parallel Randomized study
8
Pressure
Healing of all wounds
Edsberg LE et al
Ostomy and Wound Management
Case report
1
Diabetic
Healing of 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
Upson AV
Physical Therapy
Case series
2
Arterial
Positive experience
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
Australian NZ Journal of Medicine
Case report
2
Diabetic
Good healing in both cases
Heng MC et al
Archives Dermatology
Prospective non- randomized study
6
Necrotic Pressure
100% healing in TOT group
Heng MC
Australian Journal Dermatology
Case report
1
Diabetic
Granulation of deep ulcer
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
The following clinical studies, case series and abstracts detail the safety, efficacy and effectiveness of Topical Hyperbaric Oxygen (two2™) therapy in treating and resolving a variety of ulcers
Hyperbaric and Topical Wound Oxygen: A Comparatave Study
(click to read)
The use of Topical Wound Oxygen (two2™) on Complex Recalcitrant Wounds in Multi-Morbid Patients
(click to read)
Topical Wound Oxygen (two2™) used with Standard best Practice Wound Care on Recalcitrant Lower Extremity Ulcers
(click to read)
Treatment of a Chronic Wound Patent with Takayasu's Arteritis with Topical Wound Oxygen (two2™) in an Out-Patient Setting in Latvia
(click to read)
First Experience in the Treatment of Chronic Venous Ulcers with Topical Wound Oxygen (two2™) in an Out-Patient Setting in Latvia
(click to read)
Treatment of a Chronic Stage IV Pressure Ulcer using Topical Wound Oxygen (two2™)
(click to read)
Therapy of a Septic Forefoot Phlegmone with Topical Wound Oxygen (two2™) in an Intensive Care Setting
(click to read)
Limb Salvage with Topical Wound Oxygen (two2™) – Two Cases of Complex Wounds in Multimorbid Patients and Imminent Major Amputation
(click to read)
A Randomized Controlled Trial to Evaluate Different Treatment Regimes with Topical Wound Oxygen (two2™) on Chronic Wounds
(click to read)
Topical Wound Oxygen (two2™) in Two Cases With Pressure Ulcers in Finland
(click to read)
Topical Wound Oxygen (two2™) Therapy in the Treatment of Severe Diabetic Foot Ulcers: A Prospective Controlled Study
(click to read)
Treatment of a Chronic Stage IV Pressure Ulcer using Topical Wound Oxygen (two2™) Therapy
(click to read)
Cost-Effectiveness of Localized Topical Oxygen vs. Advanced Wound Care in Chronic Wounds
(click to read)
Topical Wound Oxygen Therapy in the Treatment of Severe Diabetic Foot Ulcers: A Prospective Cohort Study
(click to read)
Does Topical Wound Oxygen (TWO2) Offer an Improved Outcome Over Conventional Compression Dressings (CCD) in the Management of Refractory Venous Ulcers (RVU)? A Parallel Observational Comparative Study
(click to read abstract)

Topical Wound Oxygen (two2™) Versus Conventional Compression Dressings in the Management of Refractory Non-healing Venous Ulcers; A Parallel Observational Pivotal Study, Tawfick & Sultan, IJMS, May 2007
(click to read abstract)

Therapeutic value of hyperbaric oxygen in lower extremity ulcerations, Rossi, IJMS, May 2007
(click to read abstract)

Topical Oxygen alters angiogenesis-related growth factor expression in chronic diabetic foot ulcers, Scott, IJMS, May 2007
(click to read abstract)

Topical Hyperbaric Oxygen Therapy (THOT): Design concept to Market Product, Loori, IJMS, May 2007
(click to read abstract)

Canada TWO Case Series - TOPICAL HYPERBARIC OXYGEN THERAPY: A CASE STUDY, Dutton, 2006
(click to read abstract)

Sacral unit Case Study, Edsberg, Ostomy Wound Management, 2006
(click to read abstract)

TPOT and Electrical Stim: Exploring Potential Synergy. Edsberg, Ostomy Wound Management, April 2003
(click to read abstract)

TPOT Stimulate Growth Factors, Scott, Oct 2005
(click to read abstract)

THOT for Pressure Sores and Ulcers, Fischer, Lancet, Aug 1969
(click to read abstract)

Treatment of leg Ulcers with THOT, Fischer, Jnl Derm Surg, Oct 1975
(click to read abstract)

Effects of Hyperbaric Oxygen on Lower Extremity Ulcers, Diamond, Jnl American Podiatry Assc, Apr 1982
(click to read abstract)

Topical Hyperbaric Oxygen Therapy For Lower-Extremity Wound Care; An Overview, Rossi, Podiatry Management, Nov 1997
(click to read abstract)

THOT for Recalcitant Wounds, Upson.Physical Therapy, Sep 1986
(click to read abstract)

Reducing Epibole Using TPOT, Edsberg, Ostomy Wound Care, Apr 2002
(click to read abstract)

Human Bite Infections and TPOT, Lehman, Infections in Surgery, Jun 1985
(click to read abstract)

Angiogenesis in Necrotiv Ulcers with Topical O2, Heng, Ostomy Wound Management, Sep 2000
(click to read abstract)

Effect of Continuous Topical O2, Kaufman, Journal of Trauma, Sep 1983
(click to read abstract)

Revisiting Role of O2 In Wound Healing, Gordillo, AM J Surgery, Sep 2003.doc
(click to read abstract)

THOT and Laser, Landoz, Am Orth Trauma Surg, Jan 1998
(click to read abstract)

THOT for Leg Ulcers, Ignacio, Jnl Am Podiatric Asc, Apr 1985
(click to read abstract)

Topical O2 as an adjunct to wound healing, Kallianlnen, Pathophysiology, Nov 2002
(click to read abstract)

Topical O2 For Problem Skin Wounds, Heng, Dermatol, Surg, 1993
(click to read abstract)

Topical O2 in Burns, Kaufman
(click to read abstract)

Topical O2 Promotes Ulcer Healing, Olejanack, Medical Times, Dec 1976
(click to read abstract)

Treatment of leg Ulcers with THOT, Fischer, Jnl Derm Surg, Oct 1975
(click to read abstract)

Enh Healing and Cost Eff Heng Ostomy Wound Care Mar 2000
(click to read abstract)