Difference between revisions of "Perren"

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==<span style="font-size: 14pt;">The addition of HBOT to standard wound care improved healing rate in diabetic foot ulcers.</span>==
 
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| # '''The addition of HBOT improved wound area and depth at four weeks.'''
 
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**<span style="font-size: 11pt;">Citation/s: </span>'''<span style="font-size: 11pt;">Perren S, Gatt A, Papanas N, Formosa C. Hyperbaric Oxygen Therapy in Ischemic Foot Ulcers in Type 2 Diabetes: A Clinical Trial. The Open Cardiovascular Medicine Journal 2018; 12:80.</span>
 
  
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<span style="font-size: 11pt;"> '''Lead author's name and fax:''' Alfred.Gatt@um.edu.mt</span>
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<span style="line-height:normal">'''<span style="font-size:18.0pt"><span style="color:black">Weak evidence that hyperbaric oxygen decreased depth and area of ischaemic diabetic foot ulcers</span></span>'''</span>
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<span style="line-height:normal">'''<span style="font-size:14.0pt"><span style="color:black">Clinical Bottom Line:</span></span>'''</span>
  
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**<span style="font-size: 11pt;">Three-part Clinical Question:</span>'''<span style="font-size: 11pt;"> For diabetic patients with a newly diagnosed ischemic foot ulcer, does the addition of HBOT to standard wound care result in improved healing?</span>
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{| class="Table" style="width: 784px; border: 1pt solid windowtext;" width="0"
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| style="border: 1pt solid windowtext; width: 770px;" |
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<span style="line-height:normal"><span style="height:24.1pt"><span style="font-size:14.0pt">1. Hyperbaric oxygen therapy decreased wound depth, but not surface area of ischaemic diabetic foot ulcers.</span></span></span>
  
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<span style="font-size: 11pt;"> '''Search Terms:''' diabetes, chronic wound, skin ulcer, ischaemia</span>
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**<span style="font-size: 11pt;">The Study: </span>'''<span style="font-size: 11pt;">Non-blinded randomised controlled trial with intention-to-treat.</span>
 
  
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<span style="font-size: 11pt;"> '''The Study Patients:''' Adults with type 2 diabetes and a newly diagnosed ischemic DFU. </span>
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<span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="color:black">Citation:</span></span>'''<span style="font-size:12.0pt"><span style="color:black">1.'''</span></span><span style="font-size:12.0pt"><span style="color:black">Perren S, Gatt A, Papanas N, Formosa C. Hyperbaric Oxygen Therapy in Ischaemic Foot Ulcers in Type 2 Diabetes: A Clinical Trial. Open Cardiovasc Med J. 2018 Aug 31;12:80-85.<br/> '''Lead author's name and fax: '''Alfred Gatt, Fax 003562342</span></span></span>
  
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<span style="font-size: 11pt;"> '''Control group''' (N = 13; 13 analysed): Standard wound care including </span><span style="color: #000000; font-size: 11pt;">cleansing, optimised glycaemic control, treating infection, improving blood supply and relieving pressure on the wound site</span>.
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<span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="color:black">Three-part Clinical Question:</span></span>'''<span style="font-size:12.0pt"><span style="color:black">In diabetic patients with newly diagnosed ischaemic foot ulcers, does the addition of hyperbaric oxygen to standard wound care decrease wound size.<br/> '''Search Terms:''' Hyperbaric, diabetic foot ulcers; ischaemia</span></span></span>
  
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**<span style="font-size: 110%;">Experimental group</span>''' (N = 13; 13 analysed): SWC and daily 100% oxygen under increased atmospheric pressure (ATA not specified) for two hours from Monday to Friday to 40 sessions.
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<span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="color:black">The Study:</span></span>'''<span style="font-size:12.0pt"><span style="color:black">Non-blinded randomised controlled trial with intention-to-treat.<br/> '''The Study Patients:''' Patients with T2DM, newly diagnosed ischaemic foot ulcer, and evidence of severe arterial disease.<br/> '''Control group''' (N = 13 ; 13 analysed): Standard wound care including cleansing, good glycaemic control and improving blood supply.<br/> '''Experimental group''' (N = 13 ; 13 analysed): As above plus 100% oxygen in chamber five days per week for two hours to a total of 40 treatments – treatment pressure not stated.</span></span></span>
  
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**<span style="font-size: 11pt;">The Evidence:</span>'''
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<span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="color:black">The Evidence:</span></span>'''</span>
  
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{|  
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{| class="Table" style="border:solid windowtext 1.0pt"
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| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 10pt;">Measure</span>'''</span></span> |||| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 10pt;">HBOT Group</span>'''</span></span> |||| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 10pt;">Control Group</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 10pt;">Difference</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style="font-size: 10pt;">95% CI</span>'''</span></span>
 
 
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|^  || '''Mean''' || '''SD''' || '''Mean''' || '''SD''' ||^  ||^ 
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| rowspan="2" style="width:208.95pt; border:solid windowtext 1.0pt" width="282" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''Measure'''</span></p>
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| colspan="2" style="width:62.2pt; border:solid windowtext 1.0pt" width="85" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''Control Group'''</span></p>
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| colspan="2" style="width:54.75pt; 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">'''HBOT Group'''</span></p>
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| rowspan="2" style="width:50.15pt; border:solid windowtext 1.0pt" width="71" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''Difference'''</span></p>
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| rowspan="2" style="width:65.75pt; border:solid windowtext 1.0pt" width="91" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''95% CI'''</span></p>
 
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| '''<span style'''"font-size: 10pt;">Wound depth (cm) at week 4</span>''' || <span style'''"font-size: 10pt;">0.71</span> || <span style'''"font-size: 10pt;">0.25</span> || <span style'''"font-size: 10pt;">1.34</span> || <span style'''"font-size: 10pt;">0.29</span> || <span style'''"font-size: 10pt;">0.63</span> || <span style="font-size: 10pt;">0.41 to 0.85</span>  
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| style="width:33.9pt; 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">Mean</span></p>
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| style="width:26.8pt; border:solid windowtext 1.0pt" width="38" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">SD</span></p>
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| style="width:28.45pt; border:solid windowtext 1.0pt" width="41" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">Mean</span></p>
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| style="width:24.8pt; border:solid windowtext 1.0pt" width="35" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">SD</span></p>  
 
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| '''<span style'''"font-size: 10pt;">Wound surface area (cm2) at week 4</span>''' || <span style'''"font-size: 10pt;">9.55</span> || <span style'''"font-size: 10pt;">0.84</span> || <span style'''"font-size: 10pt;">7.98</span> || <span style'''"font-size: 10pt;">1.95</span> || <span style'''"font-size: 10pt;">1.57</span> || <span style="font-size: 10pt;">0.36 to 2.79</span>  
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| style="width:208.95pt; border:solid windowtext 1.0pt" width="282" |
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<span style="line-height:normal">'''Wound surface area reduction at 4 weeks (cm<sup>2</sup>)'''</span>
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| style="width:33.9pt; 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">9.6</span></p>
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| style="width:26.8pt; border:solid windowtext 1.0pt" width="38" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">0.8</span></p>
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| style="width:28.45pt; border:solid windowtext 1.0pt" width="41" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">7.9</span></p>
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| style="width:24.8pt; border:solid windowtext 1.0pt" width="35" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">2.0</span></p>
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| style="width:50.15pt; border:solid windowtext 1.0pt" width="71" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">-1.7</span></p>
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| style="width:65.75pt; border:solid windowtext 1.0pt" width="91" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">-0.16 to 3.48</span></p>  
 
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| style="width:208.95pt; border:solid windowtext 1.0pt" width="282" |
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<span style="line-height:normal">'''Mean depth of ulcer at 4 weeks (cm)'''</span>
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| style="width:33.9pt; 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">1.3</span></p>
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| style="width:26.8pt; border:solid windowtext 1.0pt" width="38" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">0.3</span></p>
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| style="width:28.45pt; border:solid windowtext 1.0pt" width="41" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">0.7</span></p>
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| style="width:24.8pt; border:solid windowtext 1.0pt" width="35" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">0.25</span></p>
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| style="width:50.15pt; border:solid windowtext 1.0pt" width="71" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">-0.6</span></p>
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| style="width:65.75pt; border:solid windowtext 1.0pt" width="91" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">-0.69 to -0.57</span></p>
 
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**<span style="font-size: 11pt;">Comments:</span>'''
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<span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="color:black">Comments:</span></span>'''<br/> <span style="font-size:12.0pt"><span style="color:black">1. Poorly reported study. Small, unblinded trial, randomisation method not stated but patients matched for wound size and location, no sham. Some doubt about timing of outcome measure – may have been halfway through treatment!</span></span></span>
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<span style="font-size: 11pt;"> 1. No sham treatment. The patient were randomized and matched for age, gender, DM duration, current medication, HbA1c, wound size and location using frequency distribution matching. Tight matching increases power by decreasing variability between groups but may eliminate allocation concealment.</span>
 
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<span style="font-size: 11pt;"> 2. Results given at four weeks, which seems to be after only half the HBOT treatments!</span>
 
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<span style="font-size: 11pt;"> 3. All investigations are made by the same investigator to ensure uniformity.</span>
 
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<span style="font-size: 11pt;"> 4. Standard wound care seems comprehensive</span>
 
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<span style="font-size: 11pt;">'''Appraised by:''' Cecilia Bondjers; Thursday, 1 November 2018</span>
 
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<span style="font-size: 11pt;"> '''Email:''' cecilia.bondjers@vgregion.se</span>
 
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<span style="font-size: 11pt;"> '''Kill or Update By:''' July 2021.</span>
 
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<span style="display: block; text-align: center;">
 
  
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[[File:sumhorsa.gif]]
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<span style="line-height:normal"><span style="font-size:12.0pt"><span style="color:black">2. Oxygen treatment regimens not given or discoverable from references.</span></span></span>
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</span>
 
  
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<span style="color: #7c00ff; display: block; font-size: 26px; text-align: center;">'''[[Non-healing wounds  | BACK]]'''</span>
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<span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="color:black">Appraised by:</span></span>'''<span style="font-size:12.0pt"><span style="color:black">Mary Grealish and Cecilia Bondjers POWH; Tuesday, 7 September 2021<br/> '''Email:''' Mary.Grealish@health.nsw.gov.au<br/> '''Kill or Update By:''' Sept 2022</span></span></span>
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<p style="text-align: center;">&nbsp;</p> <p style="text-align: center;">[[File:Sumhorsa.gif|RTENOTITLE]]</p>
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<span style="color: #7c00ff; display: block; font-size: 26px; text-align: center;">'''[[Non-healing_wounds|BACK]]'''</span>

Revision as of 00:20, 15 September 2021

Weak evidence that hyperbaric oxygen decreased depth and area of ischaemic diabetic foot ulcers

Clinical Bottom Line:

1. Hyperbaric oxygen therapy decreased wound depth, but not surface area of ischaemic diabetic foot ulcers.

Citation:1.Perren S, Gatt A, Papanas N, Formosa C. Hyperbaric Oxygen Therapy in Ischaemic Foot Ulcers in Type 2 Diabetes: A Clinical Trial. Open Cardiovasc Med J. 2018 Aug 31;12:80-85.
Lead author's name and fax: Alfred Gatt, Fax 003562342

Three-part Clinical Question:In diabetic patients with newly diagnosed ischaemic foot ulcers, does the addition of hyperbaric oxygen to standard wound care decrease wound size.
Search Terms: Hyperbaric, diabetic foot ulcers; ischaemia

The Study:Non-blinded randomised controlled trial with intention-to-treat.
The Study Patients: Patients with T2DM, newly diagnosed ischaemic foot ulcer, and evidence of severe arterial disease.
Control group (N = 13 ; 13 analysed): Standard wound care including cleansing, good glycaemic control and improving blood supply.
Experimental group (N = 13 ; 13 analysed): As above plus 100% oxygen in chamber five days per week for two hours to a total of 40 treatments – treatment pressure not stated.

The Evidence:

Measure

Control Group

HBOT Group

Difference

95% CI

Mean

SD

Mean

SD

Wound surface area reduction at 4 weeks (cm2)

9.6

0.8

7.9

2.0

-1.7

-0.16 to 3.48

Mean depth of ulcer at 4 weeks (cm)

1.3

0.3

0.7

0.25

-0.6

-0.69 to -0.57

Comments:
1. Poorly reported study. Small, unblinded trial, randomisation method not stated but patients matched for wound size and location, no sham. Some doubt about timing of outcome measure – may have been halfway through treatment!

2. Oxygen treatment regimens not given or discoverable from references.

Appraised by:Mary Grealish and Cecilia Bondjers POWH; Tuesday, 7 September 2021
Email: Mary.Grealish@health.nsw.gov.au
Kill or Update By: Sept 2022

 

RTENOTITLE

BACK

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