Difference between revisions of "Wadee"

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'''<span style="font-size:18.0pt"><span style="font-family:" times="" new="" roman",serif"="">Hyperbaric oxygen may improve transcutaneous oxygen tension in chronic diabetic foot ulcers.</span></span>'''
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'''<span style="font-size:18.0pt"><span style="font-family:">Hyperbaric oxygen may improve transcutaneous oxygen tension in chronic diabetic foot ulcers.</span></span>'''
  
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'''<span style="font-size:14.0pt"><span style="font-family:" times="" new="" roman",serif"="">Clinical bottom line:</span></span>'''
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'''<span style="font-size:14.0pt"><span style="font-family:">Clinical bottom line:</span></span>'''
  
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#<span style="font-size:large;"><span style="font-family:" times="" new="" roman",serif"="">No clinical outcome was assessed</span></span>  
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#<span style="font-size:large;"><span style="font-family:">No clinical outcome was assessed</span></span>  
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#<span style="font-size:large;"><span style="font-family:" times="" new="" roman",serif"="">Hyperbaric resulted in improvement in transcutaneous oxygen tension</span></span>  
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#<span style="font-size:large;"><span style="font-family:">Hyperbaric resulted in improvement in transcutaneous oxygen tension</span></span>  
  
 
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<span style="font-size:medium;">'''<span style="font-family:" times="" new="" roman",serif"="">Citation/s:</span>'''<span style="font-family:" times="" new="" roman",serif"="">1. Wadee AN, Aref MH, Nassar AA, Aboughaleb IH, Fahmy SM. The influence of low-intensity laser irradiation versus hyperbaric oxygen therapy on transcutaneous oxygen tension in chronic diabetic foot ulcers: a controlled randomised trial. Journal of Diabetes & Metabolic Disorders. 2021 Sep 3:1-9.</span></span>
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<span style="font-size:medium;">'''<span style="font-family:">Citation/s:</span>'''<span style="font-family:">1. Wadee AN, Aref MH, Nassar AA, Aboughaleb IH, Fahmy SM. The influence of low-intensity laser irradiation versus hyperbaric oxygen therapy on transcutaneous oxygen tension in chronic diabetic foot ulcers: a controlled randomised trial. Journal of Diabetes & Metabolic Disorders. 2021 Sep 3:1-9.</span></span>
  
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'''<span style="font-family:" times="" new="" roman",serif"="">Lead author’s name and fax:</span>'''<span style="font-size: medium; font-family: " times="" new="" roman",="" serif;"="">Amir N. Wadee : anazih@cu.edu.eg</span>
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'''<span style="font-family:">Lead author’s name and fax:</span>'''<span style="font-size: medium; font-family:">Amir N. Wadee&nbsp;: anazih@cu.edu.eg</span>
  
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'''<span style="font-family:" times="" new="" roman",serif"="">Three-part Clinical Question:</span>'''<span style="font-size: medium; font-family: " times="" new="" roman",="" serif;"="">For patients with chronic diabetic foot ulcers, does treatment with hyperbaric oxygen or low-intensity laser irradiation in comparison with standard wound care lead to improvement in wound healing as assessed by transcutaneous oxygen tension?</span>
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'''<span style="font-family:">Three-part Clinical Question:</span>'''<span style="font-size: medium; font-family:">For patients with chronic diabetic foot ulcers, does treatment with hyperbaric oxygen or low-intensity laser irradiation in comparison with standard wound care lead to improvement in wound healing as assessed by transcutaneous oxygen tension?</span>
  
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<span style="font-size:medium;">'''<span style="font-family:" times="" new="" roman",serif"="">Search Terms:</span>'''<span style="font-family:" times="" new="" roman",serif"="">Transcutaneous oxygen tension, diode laser irradiation, chronic diabetic foot ulcer</span></span>
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<span style="font-size:medium;">'''<span style="font-family:">Search Terms:</span>'''<span style="font-family:">Transcutaneous oxygen tension, diode laser irradiation, chronic diabetic foot ulcer</span></span>
  
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'''<span style="font-family:" times="" new="" roman",serif"="">The Study:</span>'''<span style="font-size: medium; font-family: " times="" new="" roman",="" serif;"="">Non-blinded concealed randomised controlled trial with intention-to-treat.</span>
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'''<span style="font-family:">The Study:</span>'''<span style="font-size: medium; font-family:">Non-blinded concealed randomised controlled trial with intention-to-treat.</span>
  
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<span style="font-size:medium;">'''<span style="font-family:" times="" new="" roman",serif"="">The Study Patients:</span>'''<span style="font-family:" times="" new="" roman",serif"="">Adult patients with type 2 diabetes mellitus and chronic diabetic foot ulcers (Wagner Grade 2) present for less than 6 weeks. Patients with a history of underlying respiratory, cardiac or ENT conditions or disorders predisposing to ulcer formation (other than diabetes) were excluded.</span></span>
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<span style="font-size:medium;">'''<span style="font-family:">The Study Patients:</span>'''<span style="font-family:">Adult patients with type 2 diabetes mellitus and chronic diabetic foot ulcers (Wagner Grade 2) present for less than 6 weeks. Patients with a history of underlying respiratory, cardiac or ENT conditions or disorders predisposing to ulcer formation (other than diabetes) were excluded.</span></span>
  
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<span style="font-size:medium;">'''<span style="font-family:" times="" new="" roman",serif"="">Control group</span>'''<span style="font-family:" times="" new="" roman",serif"="">(N = 25; 25 analysed): Conventional wound care (saline wash and dressing) twice daily for 6 weeks.</span></span>
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<span style="font-size:medium;">'''<span style="font-family:">Control group</span>'''<span style="font-family:">(N = 25; 25 analysed): Conventional wound care (saline wash and dressing) twice daily for 6 weeks.</span></span>
  
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<span style="font-size:medium;">'''<span style="font-family:" times="" new="" roman",serif"="">Experimental group</span>'''<span style="font-family:" times="" new="" roman",serif"="">(N = 25; 25 analysed): Conventional wound care and HBOT 100% O2 at 2.5 ATA for 90 minutes 5 days per week for 6 weeks for a total of 30 sessions.</span></span>
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<span style="font-size:medium;">'''<span style="font-family:">Experimental group</span>'''<span style="font-family:">(N = 25; 25 analysed): Conventional wound care and HBOT 100% O2 at 2.5 ATA for 90 minutes 5 days per week for 6 weeks for a total of 30 sessions.</span></span>
  
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'''<span style="font-family:" times="" new="" roman",serif"="">The Evidence:</span>'''
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'''<span style="font-family:">The Evidence:</span>'''
  
 
{| class="MsoTableGrid" style="border-collapse:collapse; border:solid windowtext 1.0pt"
 
{| class="MsoTableGrid" style="border-collapse:collapse; border:solid windowtext 1.0pt"
 
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| rowspan="2" style="width:92.9pt; border:solid windowtext 1.0pt" width="124" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:" times="" new="" roman",serif"="">Measure</span>'''</span></span></p>  
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| rowspan="2" style="width:92.9pt; border:solid windowtext 1.0pt" width="124" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:">Measure</span>'''</span></span></p>  
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| colspan="2" style="width:97.2pt; border:solid windowtext 1.0pt; border-left:none" width="130" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:" times="" new="" roman",serif"="">Control Group</span>'''</span></span></p>  
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| colspan="2" style="width:97.2pt; border:solid windowtext 1.0pt; border-left:none" width="130" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:">Control Group</span>'''</span></span></p>  
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| colspan="2" style="width:107.35pt; border:solid windowtext 1.0pt; border-left:none" width="143" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:" times="" new="" roman",serif"="">HBOT Group</span>'''</span></span></p>  
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| colspan="2" style="width:107.35pt; border:solid windowtext 1.0pt; border-left:none" width="143" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:">HBOT Group</span>'''</span></span></p>  
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| rowspan="2" style="width:70.85pt; border:solid windowtext 1.0pt; border-left:none" width="94" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:" times="" new="" roman",serif"="">Difference</span>'''</span></span></p>  
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| rowspan="2" style="width:70.85pt; border:solid windowtext 1.0pt; border-left:none" width="94" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:">Difference</span>'''</span></span></p>  
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| rowspan="2" style="width:82.5pt; border:solid windowtext 1.0pt; border-left:none" width="110" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:" times="" new="" roman",serif"="">95% CI</span>'''</span></span></p>  
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| rowspan="2" style="width:82.5pt; border:solid windowtext 1.0pt; border-left:none" width="110" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:">95% CI</span>'''</span></span></p>  
 
|- style="height:13.05pt"
 
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| style="width:48.3pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="64" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:" times="" new="" roman",serif"="">Mean</span>'''</span></span></p>  
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| style="width:48.3pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="64" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:">Mean</span>'''</span></span></p>  
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| style="width:48.9pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="65" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:" times="" new="" roman",serif"="">SD</span>'''</span></span></p>  
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| style="width:48.9pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="65" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:">SD</span>'''</span></span></p>  
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| style="width:50.65pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="68" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:" times="" new="" roman",serif"="">Mean</span>'''</span></span></p>  
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| style="width:50.65pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="68" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:">Mean</span>'''</span></span></p>  
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| style="width:2.0cm; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="76" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:" times="" new="" roman",serif"="">SD</span>'''</span></span></p>  
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| style="width:2.0cm; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="76" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:">SD</span>'''</span></span></p>  
 
|- style="height:13.05pt"
 
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| style="width:92.9pt; border:solid windowtext 1.0pt; border-top:none" width="124" |  
 
| style="width:92.9pt; border:solid windowtext 1.0pt; border-top:none" width="124" |  
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<span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:" times="" new="" roman",serif"="">Transcutaneous oxygen tension</span>'''</span></span>
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<span style="font-size:medium;"><span style="height:13.05pt">'''<span style="font-family:">Transcutaneous oxygen tension</span>'''</span></span>
  
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| style="width:48.3pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="64" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt"><span style="font-family:" times="" new="" roman",serif"="">20.0</span></span></span></p>  
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| style="width:48.3pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="64" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt"><span style="font-family:">20.0</span></span></span></p>  
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| style="width:48.9pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="65" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt"><span style="font-family:" times="" new="" roman",serif"="">10.9</span></span></span></p>  
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| style="width:48.9pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="65" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt"><span style="font-family:">10.9</span></span></span></p>  
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| style="width:50.65pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="68" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt"><span style="font-family:" times="" new="" roman",serif"="">50.2</span></span></span></p>  
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| style="width:50.65pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="68" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt"><span style="font-family:">50.2</span></span></span></p>  
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| style="width:2.0cm; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="76" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt"><span style="font-family:" times="" new="" roman",serif"="">11.1</span></span></span></p>  
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| style="width:2.0cm; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="76" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt"><span style="font-family:">11.1</span></span></span></p>  
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| style="width:70.85pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="94" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt"><span style="font-family:" times="" new="" roman",serif"="">30.2</span></span></span></p>  
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| style="width:70.85pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="94" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt"><span style="font-family:">30.2</span></span></span></p>  
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| style="width:82.5pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="110" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt"><span style="font-family:" times="" new="" roman",serif"="">-38.7 to 99.1</span></span></span></p>  
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| style="width:82.5pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="110" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:medium;"><span style="height:13.05pt"><span style="font-family:">-38.7 to 99.1</span></span></span></p>  
 
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'''<span style="font-family:" times="" new="" roman",serif"="">Comments:</span>'''
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'''<span style="font-family:">Comments:</span>'''
  
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#<span style="font-size:medium;"><span style="font-family:" times="" new="" roman",serif"="">No clinical outcome was assessed.</span></span>  
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#<span style="font-size:medium;"><span style="font-family:">No clinical outcome was assessed.</span></span>  
−
#<span style="font-size:medium;"><span style="font-family:" times="" new="" roman",serif"="">The authors analysed intragroup differences before and after treatment rather than the values between groups after treatment. We have calculated the between group differences for the wound care and wound care plus hyperbaric groups and cannot conclude there is high confidence around the estimate of improved PtcO2 with HBOT.</span></span>  
+
#<span style="font-size:medium;"><span style="font-family:">The authors analysed intragroup differences before and after treatment rather than the values between groups after treatment. We have calculated the between group differences for the wound care and wound care plus hyperbaric groups and cannot conclude there is high confidence around the estimate of improved PtcO2 with HBOT.</span></span>  
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#<span style="font-size:medium;"><span style="font-family:" times="" new="" roman",serif"="">The authors described blinding and allocation concealment but as there was no sham treatment described, it is unlikely the study was actually blinded. No mention if the person measuring the transcutaneous oxygen was blinded.</span></span>  
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#<span style="font-size:medium;"><span style="font-family:">The authors described blinding and allocation concealment but as there was no sham treatment described, it is unlikely the study was actually blinded. No mention if the person measuring the transcutaneous oxygen was blinded.</span></span>  
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#<span style="font-size:medium;"><span style="font-family:" times="" new="" roman",serif"="">Conventional wound care in this study consisted of saline wash and dressing changes which is no longer common practice.</span></span>  
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#<span style="font-size:medium;"><span style="font-family:">Conventional wound care in this study consisted of saline wash and dressing changes which is no longer common practice.</span></span>  
−
#<span style="font-size:medium;"><span style="font-family:" times="" new="" roman",serif"="">The authors describe a sample size calculation, but it is not clear what the minimum difference between groups was set at.</span></span>  
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#<span style="font-size:medium;"><span style="font-family:">The authors describe a sample size calculation, but it is not clear what the minimum difference between groups was set at.</span></span>  
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#<span style="font-size:medium;"><span style="font-family:" times="" new="" roman",serif"="">The authors included a third treatment arm which assessed low intensity laser irradiation. This performed better than the control but was not as effective as hyperbaric.</span></span>  
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#<span style="font-size:medium;"><span style="font-family:">The authors included a third treatment arm which assessed low intensity laser irradiation. This performed better than the control but was not as effective as hyperbaric.</span></span>  
  
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'''<span style="font-family:" times="" new="" roman",serif"="">Appraised by:</span>'''<span style="font-size: medium; font-family: " times="" new="" roman",="" serif;"="">Hannah Rubinstein h.rubinstein@student.unsw.edu.au; Tuesday, 23 November 2021</span>
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'''<span style="font-family:">Appraised by:</span>'''<span style="font-size: medium; font-family:">Hannah Rubinstein h.rubinstein@student.unsw.edu.au; Tuesday, 23 November 2021</span>
  
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'''<span style="font-family:" times="" new="" roman",serif"="">Kill or Update By:</span>'''<span style="font-size: medium; font-family: " times="" new="" roman",="" serif;"="">November 2023</span>
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'''<span style="font-family:">Kill or Update By:</span>'''<span style="font-size: medium; font-family:">November 2023</span>
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<p style="text-align: center;">&nbsp;</p> <p style="text-align: center;">[[File:Sumhorsa.gif|center|Sumhorsa.gif]]</p> <p style="text-align: center;"><span style="font-size:xx-large;">'''[[Non-healing_wounds|BACK]]'''</span></p>

Latest revision as of 03:09, 16 December 2021

Hyperbaric oxygen may improve transcutaneous oxygen tension in chronic diabetic foot ulcers.

Clinical bottom line:

  1. No clinical outcome was assessed
  2. Hyperbaric resulted in improvement in transcutaneous oxygen tension

Citation/s:1. Wadee AN, Aref MH, Nassar AA, Aboughaleb IH, Fahmy SM. The influence of low-intensity laser irradiation versus hyperbaric oxygen therapy on transcutaneous oxygen tension in chronic diabetic foot ulcers: a controlled randomised trial. Journal of Diabetes & Metabolic Disorders. 2021 Sep 3:1-9.

Lead author’s name and fax:Amir N. Wadee : anazih@cu.edu.eg

Three-part Clinical Question:For patients with chronic diabetic foot ulcers, does treatment with hyperbaric oxygen or low-intensity laser irradiation in comparison with standard wound care lead to improvement in wound healing as assessed by transcutaneous oxygen tension?

Search Terms:Transcutaneous oxygen tension, diode laser irradiation, chronic diabetic foot ulcer

The Study:Non-blinded concealed randomised controlled trial with intention-to-treat.

The Study Patients:Adult patients with type 2 diabetes mellitus and chronic diabetic foot ulcers (Wagner Grade 2) present for less than 6 weeks. Patients with a history of underlying respiratory, cardiac or ENT conditions or disorders predisposing to ulcer formation (other than diabetes) were excluded.

Control group(N = 25; 25 analysed): Conventional wound care (saline wash and dressing) twice daily for 6 weeks.

Experimental group(N = 25; 25 analysed): Conventional wound care and HBOT 100% O2 at 2.5 ATA for 90 minutes 5 days per week for 6 weeks for a total of 30 sessions.

The Evidence:

Measure

Control Group

HBOT Group

Difference

95% CI

Mean

SD

Mean

SD

Transcutaneous oxygen tension

20.0

10.9

50.2

11.1

30.2

-38.7 to 99.1

Comments:

  1. No clinical outcome was assessed.
  2. The authors analysed intragroup differences before and after treatment rather than the values between groups after treatment. We have calculated the between group differences for the wound care and wound care plus hyperbaric groups and cannot conclude there is high confidence around the estimate of improved PtcO2 with HBOT.
  3. The authors described blinding and allocation concealment but as there was no sham treatment described, it is unlikely the study was actually blinded. No mention if the person measuring the transcutaneous oxygen was blinded.
  4. Conventional wound care in this study consisted of saline wash and dressing changes which is no longer common practice.
  5. The authors describe a sample size calculation, but it is not clear what the minimum difference between groups was set at.
  6. The authors included a third treatment arm which assessed low intensity laser irradiation. This performed better than the control but was not as effective as hyperbaric.

Appraised by:Hannah Rubinstein h.rubinstein@student.unsw.edu.au; Tuesday, 23 November 2021

Kill or Update By:November 2023

 

Sumhorsa.gif

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