scholarly journals An open‐label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis

2019 ◽  
Vol 27 (6) ◽  
pp. 680-686 ◽  
Author(s):  
William A. Marston ◽  
John C. Lantis ◽  
Stephanie C. Wu ◽  
Aksone Nouvong ◽  
Tommy D. Lee ◽  
...  
Keyword(s):  
Umbilical Cord ◽  
Diabetic Foot ◽  
Foot Ulcers ◽  
Human Umbilical Cord ◽  
Diabetic Foot Ulcers ◽  
Open Label ◽  
Open Label Trial

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 The efficacy of platelet gel derived from umbilical cord blood on diabetic foot ulcers: A double-blind randomized clinical trial

2020 ◽  
Vol 28 ◽  
pp. 100178
Author(s):  
Seyedeh Esmat Hosseini ◽  
Behnam Molavi ◽  
Alireza Goodarzi ◽  
Ahad Alizadeh ◽  
Alireza Yousefzadeh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cord Blood ◽  
Randomized Clinical Trial ◽  
Umbilical Cord ◽  
Umbilical Cord Blood ◽  
Diabetic Foot ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Platelet Gel ◽  
Double Blind

scholarly journals Spray on skin for diabetic foot ulcers: an open label randomised controlled trial

2019 ◽  
Vol 12 (1) ◽  
Author(s):  
Laurens Manning ◽  
Emma J. Hamilton ◽  
Edward Raby ◽  
Paul E. Norman ◽  
Wendy Davis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Wound Healing ◽  
Diabetic Foot ◽  
Controlled Trial ◽  
Economic Benefits ◽  
Complete Healing ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Open Label

Abstract Background One Australian loses a limb every 3 h as a result of infected diabetic foot ulcers (DFU). This common condition accounts for substantial morbidity and mortality for affected individuals and heavy economic costs for the health sector and the community. There is an urgent need to test interventions that improve wound healing time, prevent amputations and recurrent ulceration in patients presenting with DFU whilst improving quality of life and reducing health care costs. Methods One hundred and fifty eligible participants will be randomised to receive an autologous skin cell suspension, also termed ‘spray-on’ skin (ReCell®) or standard care interventions for their DFU. The primary outcome is complete wound healing at 6 months, but participants will be followed up for a total of 12 months to enable secondary outcomes including total overall costs, ulcer free days at 12 months and quality of life to be assessed. Discussion Outpatient costs for dressings, home nursing visits and outpatient appointments are key cost drivers for DFU. If spray-on skin is effective, large cost savings to WA Health will be realised immediately through a shortened time to healing, and through a higher proportion of patients achieving complete healing. Shortened healing times may enable participants to return to work earlier. Any economic benefits are likely to be amplified across Australia and other similar demographic settings where aging populations with increased diabetes rates are considered major future challenges. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12618000511235. Registered on 9 April 2018.

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