Relationship between hyperbaric oxygen therapy and quality of life in participants with chronic diabetic foot ulcers: data from a randomized controlled trial
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To investigate the effect of hyperbaric oxygen therapy on health-related quality of life (HRQoL) in participants with diabetes and chronic foot ulcers.
Using data from a randomized controlled trial, we included 103 participants (49 in hyperbaric oxygen therapy group and 54 in sham group) for analyses. The primary outcome was HRQoL as measured by the EQ-5D-3L instrument, while secondary outcomes included quality of life evaluated by the Short Form 36 (SF-36) and Diabetic Foot Ulcers Scale-Short Form (DFS-SF). We used the analysis of covariance to assess whether the EQ-5D index values in hyperbaric oxygen therapy group differed from the sham group. Logistic regression was used to assess the relationship between hyperbaric oxygen therapy and the responses of ‘problems’ for the EQ-5D health states.
No significant differences in EQ-5D index values were found between the hyperbaric oxygen therapy and sham groups: 0.01 (95% CI −0.25, 0.28; p = 0.93) at week 12; 0.07 (95% CI −0.21, 0.34; p = 0.64) at week 6. Hyperbaric oxygen therapy was found to be associated with fewer participants reporting ‘problems’ in mobility (OR 0.24, 95% CI 0.07, 0.85 at week 12) and pain or discomfort (OR 0.20, 95% CI 0.07, 0.61 at week 6; OR 0.32, 95% CI 0.11, 0.97 at week 12), compared with the sham group. No significant differences in SF-36 or DFS-SF were observed.
No significant effect of hyperbaric oxygen therapy on HRQoL measured by EQ-5D index value was found in this study. Due to the potential insufficient power to assess statistical difference, more large-scale research is needed to further evaluate the effect of hyperbaric oxygen therapy on HRQoL in participants with chronic diabetic foot ulcers.
KeywordsDiabetes Foot ulcers Hyperbaric oxygen therapy Quality of life EQ-5D
Analysis of covariance
Body mass index
Diabetic Foot Ulcers Scale-Short Form
Health-related quality of life
Randomized controlled trial
The Short Form 36
The RCT was funded by a research grant from the Ontario Ministry of Health and Long-Term Care (06129). GL receives a Michael G. DeGroote Fellowship Award in Clinical Research from McMaster University (RFHSC 2000005835). The sponsors did not get involved in study design, data collection, data analysis, manuscript preparation or publication decisions.
GL, RBH, MAHL and DJO conceived the study design. RBH, JMB, RG, LF and DJO collected the data. GL, RBH and LT analyzed and interpreted the data. GL and DJO drafted the manuscript. RBH, MAHL, XJ, JMB, LT, RG and LF made critical revisions to the manuscript. All authors read and approved the final version.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interests.
The RCT was approved by the Research Ethics Board (REB) at St. Joseph’s Healthcare Hamilton (#08-3017) and the University Health Network in Toronto (#07-0586-AE).
Human and animal rights
All procedures were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008.
Informed consent was obtained from all participants in this study.
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