Difference between revisions of "Wang"

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==<span style="font-size: 14pt;">Extracorporeal shock wave therapy (ESWT) more effective than HBOT for treating diabetic foot ulcers</span>==  
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==<span style="font-size: 12pt;">Clinical bottom line:</span>==
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<span style="line-height:normal">'''<span style="font-size:18.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">Extracorporeal shockwave therapy may be better than hyperbaric oxygen for healing diabetic ulcers.</span></span></span>'''</span>
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| '''1. ESWT was more effective at healing ulcers by the end of treatment period (NNT ''' 3).'''=
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<span style="line-height:normal"><span style="height:26.55pt">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">1. Some poor evidence that ESWT may be effective in stimulating healing of diabetic ulcers.</span></span></span>'''</span></span>
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==='''Citation/s:'''===
 
  
<span style="font-size: 110%;">Wang C-J, Wu R-W, Yang, Y-J. Treatment of diabetic foot ulcers: A comparative study of extracorporeal shockwave therapy and hyperbaric oxygen therapy. Diabetes Research and Clinical Practice 2011;92(2):187-193</span>
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<span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">Citation/s:</span></span></span>'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">1.Wang CJ, Kuo YR, Wu RW, Liu RT, Hsu CS, Wang FS, Yang KD. Extracorporeal shockwave treatment for chronic diabetic foot ulcers. J Surg Res. 2009 Mar;152(1):96-103. doi: 10.1016/j.jss.2008.01.026. Epub 2008 Mar7<br/> '''Lead author's name and fax: '''Chin-Jen Wang : w281211@cgmh.org.tw</span></span></span></span>
  
<span style="font-size: 110%;">'''Lead author's name and fax''': Ching-Jen Wang Fax: +886 7 733 5515; Email: w281211@adm.cgmh.org.tw</span>
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<span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">Three-part Clinical Question:</span></span></span>'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">For adult patients with chronic diabetic ulcers, does the use of extracorporeal shockwave therapy (ESWT) compared to hyperbaric oxygen, result in improved healing?<br/> '''Search Terms:''' ESWT; diabetic ulcer; blood flow</span></span></span></span>
<span style="font-size: 110%;">'''Three-part Clinical Question''': Is the use of extracorporeal shockwave therapy (ESWT) more effective than hyperbaric oxygen therapy (HBOT) for the treatment of patients with chronic diabetic foot ulcers (DFUs)?</span>
 
  
<span style="font-size: 110%;">'''Search Terms''': Diabetic foot ulcer; shockwave therapy</span>
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<span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">The Study:</span></span></span>'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">Non-blinded non-randomised trial without intention-to-treat.<br/> '''The Study Patients:''' Recurrent diabetic ulcers of at least 3 months duration. Sepsis and gangrene excluded.<br/> '''Control group''' (N = 36; 34 analysed): ESWT 300 &nbsp;+ 100/cm<sup>2</sup> impulses of shockwave at 0.11 mJ/cm<sup>2</sup> energy flux density evenly applied to the ulcer surface once every 2 wk for a total of three treatments in 6 weeks. Repeat course if not complete healing.<br/> '''Experimental group''' (N = 38; 36 analysed): 100% oxygen breathing at 2.5 ATA for 90 minutes daily, five days each week to a total of 20 sessions.</span></span></span></span>
<span style="font-size: 110%;">'''The Study''': Non-blinded randomised controlled trial without intention-to-treat.</span>
 
  
<span style="font-size: 110%;">'''The Study Patients''': Patients with chronic non-healing diabetic foot ulcers for more than 3 months duration. Largely Wagner grade 3 and 4 diabetic foot ulcers.</span>
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<span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">The Evidence:</span></span></span>'''</span>
  
<span style="font-size: 110%;">'''Control group''' (N = 45; 40 analysed): HBOT daily five times a week at 2.5 ATA for 90 minutes to a total of 20 treatments. Standard wound care protocol with off-loading on the affected foot, SSD cream & antibiotic at discretion of treating physician.</span>
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<span style="font-size: 110%;">'''Experimental group''' (N = 46; 44 analysed): Standard would treatment as for control, plus ESWT at ulcer area dependent dose daily five days each week.</span>
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{| class="Table" style="border:solid windowtext 1.0pt"
 
 
**<span style="font-size: 110%;">The Evidence:</span>'''
 
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| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''Outcome'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''Time to Outcome'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''ESWT Group'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''HBOT Group'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''Relative risk reduction'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''Absolute risk reduction'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''Number needed to treat'''</span></span>
 
 
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| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''Completely healed ulcers'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">4 weeks</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.52</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.22</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">57%</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.30</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">3</span></span>  
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| style="width:54.0pt; border:solid windowtext 1.0pt" width="75" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Outcome</span></span>'''</span></p>  
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| style="width:55.2pt; border:solid windowtext 1.0pt" width="76" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Time to Outcome</span></span>'''</span></p>
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| style="width:37.7pt; border:solid windowtext 1.0pt" width="52" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">ESWT</span></span>'''</span></p>
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| style="width:37.7pt; border:solid windowtext 1.0pt" width="52" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">HBOT</span></span>'''</span></p>
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| style="width:69.0pt; border:solid windowtext 1.0pt" width="94" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Relative risk reduction</span></span>'''</span></p>
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| style="width:76.45pt; border:solid windowtext 1.0pt" width="104" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Absolute risk reduction</span></span>'''</span></p>
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| style="width:108.45pt; border:solid windowtext 1.0pt" width="148" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">NNT</span></span>'''</span></p>  
 
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|^  |||||| <span style'''"display: block; text-align: right;"><span style'''"display: block; text-align: right;">95% CI:</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">21% to 94%</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.11 to 0.49</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">2 to 9</span></span>  
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| rowspan="2" style="width:54.0pt; border:solid windowtext 1.0pt" width="75" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Complete healing</span></span>'''</span></p>
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| style="width:55.2pt; border:solid windowtext 1.0pt" width="76" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">End of treatment</span></span></span></p>
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| style="width:37.7pt; border:solid windowtext 1.0pt" width="52" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.31</span></span></span></p>
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| style="width:37.7pt; border:solid windowtext 1.0pt" width="52" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.21</span></span></span></p>
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| style="width:69.0pt; border:solid windowtext 1.0pt" width="94" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">31%</span></span></span></p>
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| style="width:76.45pt; border:solid windowtext 1.0pt" width="104" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.10</span></span></span></p>
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| style="width:108.45pt; border:solid windowtext 1.0pt" width="148" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">11</span></span></span></p>  
 
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| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''>50% improved ulcers'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">4 weeks</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.30</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.13</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">56%</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.17</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">6</span></span>  
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| colspan="3" style="width:133.6pt; border:solid windowtext 1.0pt" width="180" | <p align="right" style="margin-bottom:.0001pt; text-align:right; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">95% CIs:</span></span></span></p>
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| style="width:69.0pt; border:solid windowtext 1.0pt" width="94" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">-34% to 96%</span></span></span></p>
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| style="width:76.45pt; border:solid windowtext 1.0pt" width="104" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">-0.10 to 0.29</span></span></span></p>
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| style="width:108.45pt; border:solid windowtext 1.0pt" width="148" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">NNT = 3 to INF; NNH = 10 to INF</span></span></span></p>  
 
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|^  |||||| <span style'''"display: block; text-align: right;"><span style'''"display: block; text-align: right;">95% CI:</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">2% to 100%</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.01 to 0.34</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">3 to 195</span></span>  
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| rowspan="2" style="width:54.0pt; border:solid windowtext 1.0pt" width="75" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">>50% healing</span></span>'''</span></p>
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| style="width:55.2pt; border:solid windowtext 1.0pt" width="76" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">End of treatment</span></span></span></p>
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| style="width:37.7pt; border:solid windowtext 1.0pt" width="52" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.58</span></span></span></p>
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| style="width:37.7pt; border:solid windowtext 1.0pt" width="52" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.47</span></span></span></p>
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| style="width:69.0pt; border:solid windowtext 1.0pt" width="94" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">19%</span></span></span></p>
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| style="width:76.45pt; border:solid windowtext 1.0pt" width="104" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.11</span></span></span></p>
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| style="width:108.45pt; border:solid windowtext 1.0pt" width="148" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">9</span></span></span></p>  
 
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| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''Unchanged ulcers'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">4 weeks</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.11</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.53</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">389%</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.42</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">2</span></span>  
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| colspan="3" style="width:133.6pt; border:solid windowtext 1.0pt" width="180" | <p align="right" style="margin-bottom:.0001pt; text-align:right; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">95% CIs:</span></span></span></p>
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| style="width:69.0pt; border:solid windowtext 1.0pt" width="94" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">-20% to 57%</span></span></span></p>
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| style="width:76.45pt; border:solid windowtext 1.0pt" width="104" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">-0.12 to 0.34</span></span></span></p>
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| style="width:108.45pt; border:solid windowtext 1.0pt" width="148" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">NNT = 3 to INF; NNH = 9 to INF</span></span></span></p>
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{| class="Table" style="border:solid windowtext 1.0pt"
 
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|^  |||||| <span style'''"display: block; text-align: right;"><span style'''"display: block; text-align: right;">95% CI:</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">232% to 546%</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.25 to 0.60</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">2 to 4</span></span>  
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| rowspan="2" style="width:124.95pt; border:solid windowtext 1.0pt" width="170" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Measure</span></span>'''</span></p>
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| colspan="2" style="width:76.45pt; border:solid windowtext 1.0pt" width="104" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">ESWT Group</span></span>'''</span></p>
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| colspan="2" style="width:90.65pt; border:solid windowtext 1.0pt" width="123" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">HBOT Group</span></span>'''</span></p>
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| rowspan="2" style="width:69.35pt; border:solid windowtext 1.0pt" width="94" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Difference</span></span>'''</span></p>
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| rowspan="2" style="width:80.1pt; border:solid windowtext 1.0pt" width="110" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">95% CI</span></span>'''</span></p>  
 
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| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''Non-Event Outcomes'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''Time to outcome/s'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''ESWT group''' </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''HBOT group'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''P-value'''</span></span>
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| style="width:33.95pt; border:solid windowtext 1.0pt" width="47" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Mean</span></span>'''</span></p>  
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| style="width:41.0pt; border:solid windowtext 1.0pt" width="57" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">SD</span></span>'''</span></p>  
| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''Blood flow perfusion scan'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">4 weeks</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.61 (0.40 to 0.79)</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.50 (0.11 to 0.53)</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">0.002</span></span>  
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| style="width:48.1pt; border:solid windowtext 1.0pt" width="66" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Mean</span></span>'''</span></p>  
 +
| style="width:41.05pt; border:solid windowtext 1.0pt" width="57" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">SD</span></span>'''</span></p>  
 
|-
 
|-
 +
| style="width:124.95pt; border:solid windowtext 1.0pt" width="170" |
 +
'''<span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Laser doppler blood flow after treatment (no units)</span></span></span>'''
 +
 +
| style="width:33.95pt; border:solid windowtext 1.0pt" width="47" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.75</span></span></span></p>
 +
| style="width:41.0pt; border:solid windowtext 1.0pt" width="57" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.19</span></span></span></p>
 +
| style="width:48.1pt; border:solid windowtext 1.0pt" width="66" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.58</span></span></span></p>
 +
| style="width:41.05pt; border:solid windowtext 1.0pt" width="57" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.11</span></span></span></p>
 +
| style="width:69.35pt; border:solid windowtext 1.0pt" width="94" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.17</span></span></span></p>
 +
| style="width:80.1pt; border:solid windowtext 1.0pt" width="110" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.16 to 0.18</span></span></span></p>
 
|}
 
|}
**<span style="font-size: 110%;">Comments:</span>'''
 
<span style="font-size: 110%;">1. Potential confounders not addressed in the study include ESWT may be a form of debridement and debridement not attempted in HBOT group; ambulation, immunosuppression, smoking & renal disease not taken into account</span>
 
 
<span style="font-size: 110%;">2. No effort to determine if ulcers were hypoxic. No TcPO2 measurements done to check that HBOT was indicated.</span>
 
  
<span style="font-size: 110%;">3. Short term follow-up reduces applicability of the study. Longer term outcome not known.</span>
+
&nbsp;
  
<span style="font-size: 110%;">4. Unblinded trial reduces confidence in the results given.</span>
+
<span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">Comments:</span></span></span>'''</span>
  
<span style="font-size: 110%;">'''Appraised by''': Darran Foo & Michael Bennett, Prince of Wales Hospital, Thursday, 18 September 2014</span>
+
<span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">1. Not a truly randomised study - allocation by day of referral.<br/> 2. Four patients excluded for poor compliance after randomisation<br/> 3. All patients had standard wound care in both arms. No measure of any ulcer hypoxia (e'g. PtcO<sub>2</sub>)<br/> 4. Note ESWT course potentially 12 weeks, HBOT course four weeks, so comparisons are not made at the same time in each group. Longer term outcomes not known.&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; 5.&nbsp;</span></span></span></span><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">Proportions for healing were reported as statistically significantly different in favour of ESWT.</span></span></span></span>
  
<span style="font-size: 110%;">'''Email:''' darran.foo@student.unsw.edu.au or m.bennett@unsw.edu.au</span>
+
<span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">Appraised by:</span></span></span>'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"=""><span style="color:black">&nbsp;Darren Foo & Mike Bennett m.bennett@unsw.edu.au; Monday, 6 July 2020<br/> '''Kill or Update By:''' July 2022 &nbsp;</span></span></span></span>
  
<span style="font-size: 110%;">'''Kill or Update By''': July 2021</span>
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== &nbsp; ==
  
[[File:sumhorsa.gif|center]]
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[[File:Sumhorsa.gif|center|Sumhorsa.gif]]
  
<span style="display: block; text-align: center;"><span style="font-size: 150%;">[[Non-healing wounds  | BACK]]</span>
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<span style="display: block; text-align: center;"><span style="font-size: 150%;">[[Non-healing_wounds|BACK]]</span></span>
</span>
 

Latest revision as of 21:38, 5 July 2020

Extracorporeal shockwave therapy may be better than hyperbaric oxygen for healing diabetic ulcers.

1. Some poor evidence that ESWT may be effective in stimulating healing of diabetic ulcers.

Citation/s:1.Wang CJ, Kuo YR, Wu RW, Liu RT, Hsu CS, Wang FS, Yang KD. Extracorporeal shockwave treatment for chronic diabetic foot ulcers. J Surg Res. 2009 Mar;152(1):96-103. doi: 10.1016/j.jss.2008.01.026. Epub 2008 Mar7
Lead author's name and fax: Chin-Jen Wang : w281211@cgmh.org.tw

Three-part Clinical Question:For adult patients with chronic diabetic ulcers, does the use of extracorporeal shockwave therapy (ESWT) compared to hyperbaric oxygen, result in improved healing?
Search Terms: ESWT; diabetic ulcer; blood flow

The Study:Non-blinded non-randomised trial without intention-to-treat.
The Study Patients: Recurrent diabetic ulcers of at least 3 months duration. Sepsis and gangrene excluded.
Control group (N = 36; 34 analysed): ESWT 300  + 100/cm2 impulses of shockwave at 0.11 mJ/cm2 energy flux density evenly applied to the ulcer surface once every 2 wk for a total of three treatments in 6 weeks. Repeat course if not complete healing.
Experimental group (N = 38; 36 analysed): 100% oxygen breathing at 2.5 ATA for 90 minutes daily, five days each week to a total of 20 sessions.

The Evidence:

 

Outcome

Time to Outcome

ESWT

HBOT

Relative risk reduction

Absolute risk reduction

NNT

Complete healing

End of treatment

0.31

0.21

31%

0.10

11

95% CIs:

-34% to 96%

-0.10 to 0.29

NNT = 3 to INF; NNH = 10 to INF

>50% healing

End of treatment

0.58

0.47

19%

0.11

9

95% CIs:

-20% to 57%

-0.12 to 0.34

NNT = 3 to INF; NNH = 9 to INF

 

Measure

ESWT Group

HBOT Group

Difference

95% CI

Mean

SD

Mean

SD

Laser doppler blood flow after treatment (no units)

0.75

0.19

0.58

0.11

0.17

0.16 to 0.18

 

Comments:

1. Not a truly randomised study - allocation by day of referral.
2. Four patients excluded for poor compliance after randomisation
3. All patients had standard wound care in both arms. No measure of any ulcer hypoxia (e'g. PtcO2)
4. Note ESWT course potentially 12 weeks, HBOT course four weeks, so comparisons are not made at the same time in each group. Longer term outcomes not known.                                                                                                                                                    5. 
Proportions for healing were reported as statistically significantly different in favour of ESWT.

Appraised by: Darren Foo & Mike Bennett m.bennett@unsw.edu.au; Monday, 6 July 2020
Kill or Update By: July 2022  

 

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