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Late Breaking Poster Session

Multinational, Multicenter, Prospective, 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

  1. ROBERT FRYKBERG,
  2. PETER J. FRANKS,
  3. MICHAEL E. EDMONDS,
  4. JONATHAN N. BRANTLEY,
  5. LUC TÉOT,
  6. THOMAS WILD,
  7. MATTHEW G. GAROUFALIS,
  8. ALIZA M. LEE,
  9. JANETTE THOMPSON,
  10. GERARD REACH,
  11. CYAANDI R. DOVE,
  12. KARIM LACHGAR and
  13. DIRK GROTEMEYER
  1. Phoenix, AZ, London, United Kingdom, Richmond, VA, Montpellier, France, Dessau, Germany, Chicago, IL, Salem, VA, Washington, DC, Bobigny, France, Las Vegas, NV, Eaubonne, France, Luxembourg, Luxembourg
Diabetes 2018 Jul; 67(Supplement 1): -. https://doi.org/10.2337/db18-43-LB
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Abstract

Non-healing DFUs lead to increased mortality, morbidity and health economic burden. Our RCT (NCT02326337) was undertaken to explore the efficacy of Topical Wound Oxygen (TWO2) homecare therapy in healing DFUs that had failed to heal with Standard of Care (SOC) alone. A Group Sequential Design was utilized with 2 interim analyses, requiring a significance of p<0.022 at each. All subjects meeting the incl/excl criteria were enrolled into a run-in of SOC that included gold-standard offloading and sharp debridement. Only DFUs not on a proven healing trajectory with SOC alone (<30% wound area reduction) were randomized into the active phase of the study, where they were assigned (double blind) to either active, or sham (placebo), TWO2 device treatment arms. The primary endpoint of the study was ulcers healed at 12 weeks. At the first interim analysis point of 73 subjects, the active TWO2 arm was shown to be significantly superior to the sham arm (Pearson Chi2 =7.2707, P=0.007). Multivariable analysis using logistic regression and Cox proportional hazards modelling of the secondary outcome measure of time to heal showed no other covariates achieved significance. The active TWO2 arm showed nearly 4 times the likelihood to heal DFUs in 12 weeks compared to the sham arm HR 3.88 (95% CI 1.40 to 10.71), p=0.009.

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Disclosure R. Frykberg: Research Support; Self; AOTI, Podometrics. P.J. Franks: Consultant; Self; AOTI. M.E. Edmonds: Advisory Panel; Self; Urgo Medical, Edixomed. J.N. Brantley: None. L. Téot: Advisory Panel; Self; Acelity, Integra LifeSciences. T. Wild: None. M.G. Garoufalis: None. A.M. Lee: None. J. Thompson: None. G. Reach: Other Relationship; Self; Abbott, AbbVie Inc., Janssen Pharmaceuticals, Inc., LifeScan, Inc., Eli Lilly and Company, Novo Nordisk Inc., Sanofi-Aventis, Servier, Becton, Dickinson and Company, AstraZeneca. C.R. Dove: None. K. Lachgar: None. D. Grotemeyer: Other Relationship; Self; AOTI Ltd.. Research Support; Self; Gore, Endologix.

  • © 2018 by the American Diabetes Association.
http://www.diabetesjournals.org/content/license

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.

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Diabetes: 67 (Supplement 1)

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July 2018, 67(Supplement 1)
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Multinational, Multicenter, Prospective, 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
ROBERT FRYKBERG, PETER J. FRANKS, MICHAEL E. EDMONDS, JONATHAN N. BRANTLEY, LUC TÉOT, THOMAS WILD, MATTHEW G. GAROUFALIS, ALIZA M. LEE, JANETTE THOMPSON, GERARD REACH, CYAANDI R. DOVE, KARIM LACHGAR, DIRK GROTEMEYER
Diabetes Jul 2018, 67 (Supplement 1) 43-LB; DOI: 10.2337/db18-43-LB

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Multinational, Multicenter, Prospective, 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
ROBERT FRYKBERG, PETER J. FRANKS, MICHAEL E. EDMONDS, JONATHAN N. BRANTLEY, LUC TÉOT, THOMAS WILD, MATTHEW G. GAROUFALIS, ALIZA M. LEE, JANETTE THOMPSON, GERARD REACH, CYAANDI R. DOVE, KARIM LACHGAR, DIRK GROTEMEYER
Diabetes Jul 2018, 67 (Supplement 1) 43-LB; DOI: 10.2337/db18-43-LB
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