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Acta Diabetol. 2017 Sep;54(9):823-831. doi: 10.1007/s00592-017-1012-z. Epub 2017 Jun 12.

Relationship between hyperbaric oxygen therapy and quality of life in participants with chronic diabetic foot ulcers: data from a randomized controlled trial.

Author information

1
Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada. lig28@mcmaster.ca.
2
Programs for Assessment of Technology in Health (PATH), Centre for Evaluation of Medicines, 43 Charlton Avenue East, Hamilton, ON, L8N 1Y3, Canada. lig28@mcmaster.ca.
3
St. Joseph's Healthcare Hamilton, McMaster University, 501-25 Charlton Avenue East, Hamilton, ON, L8N 1Y2, Canada. lig28@mcmaster.ca.
4
Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada.
5
Programs for Assessment of Technology in Health (PATH), Centre for Evaluation of Medicines, 43 Charlton Avenue East, Hamilton, ON, L8N 1Y3, Canada.
6
St. Joseph's Healthcare Hamilton, McMaster University, 501-25 Charlton Avenue East, Hamilton, ON, L8N 1Y2, Canada.
7
Department of Medicine, McMaster University, Hamilton, ON, L8S 4L8, Canada.
8
Toronto General Hospital, University Health Network, Toronto, ON, M4G 2C4, Canada.
9
Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada. oreilld@mcmaster.ca.
10
Programs for Assessment of Technology in Health (PATH), Centre for Evaluation of Medicines, 43 Charlton Avenue East, Hamilton, ON, L8N 1Y3, Canada. oreilld@mcmaster.ca.

Abstract

AIMS:

To investigate the effect of hyperbaric oxygen therapy on health-related quality of life (HRQoL) in participants with diabetes and chronic foot ulcers.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

KEYWORDS:

Diabetes; EQ-5D; Foot ulcers; Hyperbaric oxygen therapy; Quality of life

PMID:
28603808
DOI:
10.1007/s00592-017-1012-z
[Indexed for MEDLINE]

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