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28 Hyperbaric Oxygenation Therapy KCE Reports 74 No direct effect on minor amputations was found (see Figure 12), but it can be anticipated that the avoidance of major amputations results in an increase of minor amputations, indicating treatment success. One small trial (n=16) concerned venous ulcers and only suggested a significant benefit of HBOT at six weeks (reduction in ulcer size). For arterial and pressure ulcers not satisfactory trials were identified in this review. The authors, however, express cautious interpretation of these results in view of the small number of patients included in those trials. Forest plots illustrating these findings are shown in Figure 10 to Figure 13. Figure 10. Diabetic ulcers: Major amputations Source: Kranke et al. 32 Figure 11. Diabetic ulcers: Major amputations subgroups by use of sham Source: Kranke et al. 32
KCE Reports 74 Hyperbaric Oxygenation Therapy 29 Figure 12. Diabetic ulcers: Minor amputations Source: Kranke et al. 32 Figure 13. Venous ulcers: Wound size reduction at end treatment (six weeks). Favourable result is indicated by increased relative risk since the outcome is wound size reduction. Source: Kranke et al. 32 The labeling of the X-axis was adapted by us since a typing error inversed the labels in the original report. A HTA conducted by the Canadian Medical Advisory Secretariat (Toronto) in 2005 evaluated the same studies and came to similar conclusions, mainly that the studies are too small and that new and well-conducted RCTs are likely to change these estimates. 56, 57 The HAS and the IECS assessments, 37, 38 and also the MSAC 2003 report come to similar conclusions as to the availability of evidence. 54 In 2006, Löndahl et al. described the design of a single centre RCT to investigate efficacy of HBOT in Sweden that will include 100 patients with diabetic foot ulcers. 18 A narrative review from Räkel et al. for the Canadian Diabetes Association about diabetic foot also summarized many of the findings. 58 Within the COST B14 program (see before), a European RCT for HBOT in the treatment of foot lesions in diabetic patients (study co-ordinator: D. Mathieu, Lille, France) has started in May 2002. In 2005 it was reported that 10 centres were participating and that 56 patients had been included. 42 However, no results have been found.
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KCE reports 33 Effects and costs of
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