Difference between revisions of "Kessler"
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| − | + | <span style="font-size:large;">'''<span style="color: rgb(0, 51, 102); font-family: arial, helvetica, sans-serif;">Adjunctive hyperbaric oxygen treatment for non-ischemic diabetic foot ulcers results in more rapid healing.</span>'''</span> | |
| − | + | ||
| + | {| | ||
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| + | | <span style="font-size:large;">'''Clinical Bottom Line:'''</span><br/> <span style="font-size:medium;">1. Rate of healing improved with hyperbaric oxygen.<br/> <span style="font-family: Arial, Helvetica, sans-serif;">2. Non-significant short term increase in chance of healing with HBOT</span></span> | ||
|} | |} | ||
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Citation/s:'''Kessler L, Bilbault P, Ortega F, Grasso C, Passemard R, Stephan D, Pinget M, Schneider F. Hyperbaric oxygenation accelerates the healing rate of nonischemic chronic diabetic foot ulcers. Diabetes Care 2003; 26:2378-82.</span> | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Citation/s:'''Kessler L, Bilbault P, Ortega F, Grasso C, Passemard R, Stephan D, Pinget M, Schneider F. Hyperbaric oxygenation accelerates the healing rate of nonischemic chronic diabetic foot ulcers. Diabetes Care 2003; 26:2378-82.</span> | ||
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Lead author's name and fax:''' Laurance Kessler, MD, PHD [[mailto:laurance.kessler@medicine.u-strasbg.fr | laurance.kessler@medicine.u-strasbg.fr]] </span> | + | |
| + | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Lead author's name and fax:''' Laurance Kessler, MD, PHD [[mailto:laurance.kessler@medicine.u-strasbg.fr| laurance.kessler@medicine.u-strasbg.fr]]</span> | ||
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Three-part Clinical Question:''' In diabetic patients with foot ulcers, does the addition of hyperbaric oxygen therapy to conventional treatment result in an improvement in healing?</span> | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Three-part Clinical Question:''' In diabetic patients with foot ulcers, does the addition of hyperbaric oxygen therapy to conventional treatment result in an improvement in healing?</span> | ||
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Search Terms:''' Hyperbaric oxygen therapy, Diabetic foot ulcers </span> | + | |
| + | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Search Terms:''' Hyperbaric oxygen therapy, Diabetic foot ulcers</span> | ||
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Study:'''Single-blinded randomised controlled trial without intention-to-treat.</span> | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Study:'''Single-blinded randomised controlled trial without intention-to-treat.</span> | ||
| + | |||
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Study Patients:''' Foot ulcer with no improvement for three months despite stabilization of glycemia, absence of clinical local infection and satisfactory off-loading measures. Non-ischemic (TcPO2 > 30 mmHg).</span> | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Study Patients:''' Foot ulcer with no improvement for three months despite stabilization of glycemia, absence of clinical local infection and satisfactory off-loading measures. Non-ischemic (TcPO2 > 30 mmHg).</span> | ||
| + | |||
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Control group''' (N = 15; 14 analysed): Hospitalization for 2 weeks with standard wound care, keeping weight of affected foot, orthopedic device, optimization of metabolic control +/- antibiotics.</span> | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Control group''' (N = 15; 14 analysed): Hospitalization for 2 weeks with standard wound care, keeping weight of affected foot, orthopedic device, optimization of metabolic control +/- antibiotics.</span> | ||
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Experimental group''' (N = 15; 13 analysed): As control group plus hyperbaric oxygen treatment for 2 weeks, 5 days a week, twice daily 90 min at 2.5 ATA. </span> | + | |
| + | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Experimental group''' (N = 15; 13 analysed): As control group plus hyperbaric oxygen treatment for 2 weeks, 5 days a week, twice daily 90 min at 2.5 ATA.</span> | ||
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Evidence:'''</span> | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Evidence:'''</span> | ||
| − | {| | + | {| |
| − | |||
|- | |- | ||
| − | | ''' | + | | <span><span>'''Outcome'''</span></span> |
| + | | <span><span>'''Time to Outcome'''</span></span> | ||
| + | | <span><span>'''Control Group'''</span></span> | ||
| + | | <span><span>'''HBO Group'''</span></span> | ||
| + | | <span><span>'''Relative Risk Reduction'''</span></span> | ||
| + | | <span><span>'''Absolute Risk Reduction'''</span></span> | ||
| + | | <span><span>'''NNT'''</span></span> | ||
|- | |- | ||
| − | | | + | | '''<span>Healed</span>''' |
| + | | <span><span>4 weeks</span></span> | ||
| + | | <span><span>0</span></span> | ||
| + | | <span><span>0.133</span></span> | ||
| + | | <span><span>INF</span></span> | ||
| + | | <span><span>-0.133</span></span> | ||
| + | | <span><span style="display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">-8</span></span> | ||
|- | |- | ||
| + | | ^ | ||
| + | | | ||
| + | | | ||
| + | | <span><span>95% Confidence Intervals:</span></span> | ||
| + | | | ||
| + | | <span><span>-0.305 to 0.039</span></span> | ||
| + | | <span><span>NNT '''26 to INF'''</span></span>'''<span><span>NNH</span></span>''' 3 to INF | ||
|} | |} | ||
| − | {| | + | {| |
| − | |||
|- | |- | ||
| − | | | + | | <span><span>'''Measure'''</span></span> |
| + | | | ||
| + | | <span><span>'''Control Group'''</span></span> | ||
| + | | | ||
| + | | <span><span>'''Experimental Group'''</span></span> | ||
| + | | <span><span>'''Difference'''</span></span> | ||
| + | | <span><span>'''95% CI'''</span></span> | ||
|- | |- | ||
| − | | <span | + | | ^ |
| + | | <span>'''Mean'''</span> | ||
| + | | <span>'''SD'''</span> | ||
| + | | <span>'''Mean'''</span> | ||
| + | | <span>'''SD'''</span> | ||
| + | | ^ | ||
| + | | ^ | ||
|- | |- | ||
| − | | <span | + | | <span>'''Reduction in ulcer size''' </span><br/> <span>'''0 - 2 weeks.'''</span> |
| + | | <span>41.8%</span> | ||
| + | | <span>25.5%</span> | ||
| + | | <span>21.7%</span> | ||
| + | | <span>16.9%</span> | ||
| + | | <span>20.1</span> | ||
| + | | <span>2.8 to 37.4</span> | ||
|- | |- | ||
| − | | <span | + | | <span>'''Reduction in ulcer size''' </span><br/> <span>'''2-4 weeks.'''</span> |
| + | | <span>48.1%</span> | ||
| + | | <span>30.3%</span> | ||
| + | | <span>41.7%</span> | ||
| + | | <span>27.3%</span> | ||
| + | | <span>6.4</span> | ||
| + | | <span>-16.5 to 29.3</span> | ||
|- | |- | ||
| + | | <span>'''Reduction in ulcer size''' </span><br/> <span>'''0 - 4 weeks.'''</span> | ||
| + | | <span>61.9%</span> | ||
| + | | <span>23.3%</span> | ||
| + | | <span>55.1%</span> | ||
| + | | <span>21.5%</span> | ||
| + | | <span>6.8</span> | ||
| + | | <span>-11.0 to 24.6</span> | ||
|} | |} | ||
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Comments:'''</span> | + | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Comments:'''</span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">1. Partly blinded study.</span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">2. Small study with low power to detect differences in final healing.</span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">3. Short-term outcomes only</span> |
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">1. Partly blinded study.</span> | ||
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">2. Small study with low power to detect differences in final healing.</span> | ||
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">3. Short-term outcomes only </span> | ||
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Appraised by''': Jasper Kuipers and Mike Bennett, Prince of Wales Hospital, Sydney, Australia; Monday, May 10, 2004Email: [[mailto:j.c.j.kuipers@student.rug.nl | j.c.j.kuipers@student.rug.nl]]</span> | + | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Appraised by''': Jasper Kuipers and Mike Bennett, Prince of Wales Hospital, Sydney, Australia; Monday, May 10, 2004Email: [[mailto:j.c.j.kuipers@student.rug.nl| j.c.j.kuipers@student.rug.nl]]</span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Kill or Update By:''' July 2021</span> |
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Kill or Update By:''' July 2021</span> | ||
| − | + | | |
| − | [[File: | + | [[File:Sumhorsa.gif|center|Sumhorsa.gif]] |
| − | <span style="color: #7c00ff; display: block; font-size: 26px; text-align: center;">'''[[Non- | + | <span style="color: #7c00ff; display: block; font-size: 26px; text-align: center;">'''[[Non-healing_wounds|BACK]]'''</span> |
Latest revision as of 22:01, 4 August 2021
Adjunctive hyperbaric oxygen treatment for non-ischemic diabetic foot ulcers results in more rapid healing.
| Clinical Bottom Line: 1. Rate of healing improved with hyperbaric oxygen. 2. Non-significant short term increase in chance of healing with HBOT |
Citation/s:Kessler L, Bilbault P, Ortega F, Grasso C, Passemard R, Stephan D, Pinget M, Schneider F. Hyperbaric oxygenation accelerates the healing rate of nonischemic chronic diabetic foot ulcers. Diabetes Care 2003; 26:2378-82.
Lead author's name and fax: Laurance Kessler, MD, PHD [laurance.kessler@medicine.u-strasbg.fr]
Three-part Clinical Question: In diabetic patients with foot ulcers, does the addition of hyperbaric oxygen therapy to conventional treatment result in an improvement in healing?
Search Terms: Hyperbaric oxygen therapy, Diabetic foot ulcers
The Study:Single-blinded randomised controlled trial without intention-to-treat.
The Study Patients: Foot ulcer with no improvement for three months despite stabilization of glycemia, absence of clinical local infection and satisfactory off-loading measures. Non-ischemic (TcPO2 > 30 mmHg).
Control group (N = 15; 14 analysed): Hospitalization for 2 weeks with standard wound care, keeping weight of affected foot, orthopedic device, optimization of metabolic control +/- antibiotics.
Experimental group (N = 15; 13 analysed): As control group plus hyperbaric oxygen treatment for 2 weeks, 5 days a week, twice daily 90 min at 2.5 ATA.
The Evidence:
| Outcome | Time to Outcome | Control Group | HBO Group | Relative Risk Reduction | Absolute Risk Reduction | NNT |
| Healed | 4 weeks | 0 | 0.133 | INF | -0.133 | -8 |
| ^ | 95% Confidence Intervals: | -0.305 to 0.039 | NNT 26 to INFNNH 3 to INF |
| Measure | Control Group | Experimental Group | Difference | 95% CI | ||
| ^ | Mean | SD | Mean | SD | ^ | ^ |
| Reduction in ulcer size 0 - 2 weeks. |
41.8% | 25.5% | 21.7% | 16.9% | 20.1 | 2.8 to 37.4 |
| Reduction in ulcer size 2-4 weeks. |
48.1% | 30.3% | 41.7% | 27.3% | 6.4 | -16.5 to 29.3 |
| Reduction in ulcer size 0 - 4 weeks. |
61.9% | 23.3% | 55.1% | 21.5% | 6.8 | -11.0 to 24.6 |
Comments: 1. Partly blinded study. 2. Small study with low power to detect differences in final healing. 3. Short-term outcomes only
Appraised by: Jasper Kuipers and Mike Bennett, Prince of Wales Hospital, Sydney, Australia; Monday, May 10, 2004Email: [j.c.j.kuipers@student.rug.nl] Kill or Update By: July 2021
