scholarly journals Commentary on 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

2019 ◽  
Vol 3 (3) ◽  
Author(s):  
Robert Frykberg
Keyword(s):  
Diabetic Foot ◽  
Oxygen Therapy ◽  
Controlled Trial ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Double Blinded

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

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 43-LB ◽  
Author(s):  
ROBERT FRYKBERG ◽  
PETER J. FRANKS ◽  
MICHAEL E. EDMONDS ◽  
JONATHAN N. BRANTLEY ◽  
LUC TÉOT ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Oxygen Therapy ◽  
Controlled Trial ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Double Blinded

Efficacy of intralesional recombinant human epidermal growth factor in diabetic foot ulcers in Mexican patients: A randomized double-blinded controlled trial

2014 ◽  
Vol 22 (4) ◽  
pp. 497-503 ◽  
Author(s):  
Ramiro Gomez-Villa ◽  
Francisco Aguilar-Rebolledo ◽  
Adriana Lozano-Platonoff ◽  
Juan Miguel Teran-Soto ◽  
Maria Rosy Fabian-Victoriano ◽  
...  
Keyword(s):  
Growth Factor ◽  
Epidermal Growth Factor ◽  
Diabetic Foot ◽  
Controlled Trial ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Human Epidermal Growth Factor ◽  
Epidermal Growth ◽  
Double Blinded ◽  
Mexican Patients

Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial

2021 ◽  
Vol 30 (Sup5) ◽  
pp. S7-S14
Author(s):  
Thomas E Serena ◽  
Neal M Bullock ◽  
Windy Cole ◽  
John Lantis ◽  
Lam Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Diabetic Foot ◽  
Oxygen Therapy ◽  
Wound Closure ◽  
Foot Ulcers ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Open Label ◽  
Number Of Patients

Objectives: Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks). Method: This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events. Results: For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events. Conclusion: This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.

scholarly journals Cellular Proliferation, Dermal Repair, and Microbiological Effectiveness of Ultrasound-Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU): An Open-Label Randomized Controlled Trial

2020 ◽  
Vol 9 (12) ◽  
pp. 4032
Author(s):  
José Luis Lázaro-Martínez ◽  
Francisco Javier Álvaro-Afonso ◽  
David Sevillano-Fernández ◽  
Yolanda García-Álvarez ◽  
Irene Sanz-Corbalan ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Cellular Proliferation ◽  
Controlled Trial ◽  
Surgical Debridement ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Wound Debridement ◽  
Randomized Controlled ◽  
Ultrasound Assisted ◽  
Surgical Group

We aimed to evaluate the effects of ultrasound-assisted wound (UAW) debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgical/sharp wound debridement. A randomized controlled trial was performed involving 51 outpatients with complicated diabetic foot ulcers that either received surgical debridement (n = 24) or UAW debridement (n = 27) every week during a six-week treatment period. Compared to patients receiving surgical debridement, patients treated with UAW debridement exhibited significantly improved cellular proliferation, as determined by CD31 staining, Masson’s trichrome staining, and actin staining. Bacterial loads were significantly reduced in the UAW debridement group compared to the surgical group (UAW group 4.27 ± 0.37 day 0 to 2.11 ± 0.8 versus surgical group 4.66 ± 1.21 day 0 to 4.39 ± 1.24 day 42; p = 0.01). Time to healing was also significantly lower (p = 0.04) in the UAW group (9.7 ± 3.8 weeks) compared to the surgical group (14.8 ± 12.3 weeks), but both groups had similar rates of patients that were healed after six months of follow-up (23 patients (85.1%) in the UAW group vs. 20 patients (83.3%) in the surgical group; p = 0.856). We propose that UAW debridement could be an effective alternative when surgical debridement is not available or is contraindicated for use on patients with complicated diabetic foot ulcers.

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