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Acta Diabetologica

, Volume 54, Issue 9, pp 823–831 | Cite as

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

  • Guowei LiEmail author
  • Robert B. Hopkins
  • Mitchell A. H. Levine
  • Xuejing Jin
  • James M. Bowen
  • Lehana Thabane
  • Ron Goeree
  • Ludwik Fedorko
  • Daria J. O’ReillyEmail author
Original Article

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

Abbreviations

ANCOCA

Analysis of covariance

BMI

Body mass index

CI

Confidence interval

DFS-SF

Diabetic Foot Ulcers Scale-Short Form

HRQoL

Health-related quality of life

OR

Odds ratio

RCT

Randomized controlled trial

SD

Standard deviation

SF-36

The Short Form 36

Notes

Funding

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.

Authors’ contribution

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.

Ethical disclosure

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

Informed consent was obtained from all participants in this study.

References

  1. 1.
    Hopkins RB, Burke N, Harlock J, Jegathisawaran J, Goeree R (2015) Economic burden of illness associated with diabetic foot ulcers in Canada. BMC Health Serv Res 15:13CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Goodridge D, Trepman E, Embil JM (2005) Health-related quality of life in diabetic patients with foot ulcers: literature review. J Wound Ostomy Continence Nurs 32:368–377CrossRefPubMedGoogle Scholar
  3. 3.
    Rubin RR, Peyrot M (1999) Quality of life and diabetes. Diabetes Metab Res Rev 15:205–218CrossRefPubMedGoogle Scholar
  4. 4.
    Simo R, Hernandez C (2002) [Treatment of diabetes mellitus: general goals, and clinical practice management]. Rev Esp Cardiol 55:845–860CrossRefPubMedGoogle Scholar
  5. 5.
    Lipsky BA, Berendt AR, Cornia PB et al (2012) 2012 Infectious diseases society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis 54:e132–e173CrossRefPubMedGoogle Scholar
  6. 6.
    Alavi A, Sibbald RG, Mayer D et al (2014) Diabetic foot ulcers: part II. Management. J Am Acad Dermatol 70:21. e21-24 (quiz 45–26) CrossRefGoogle Scholar
  7. 7.
    Abidia A, Laden G, Kuhan G, Johnson BF, Wilkinson AR, Renwick PM et al (2003) The role of hyperbaric oxygen therapy in ischaemic diabetic lower extremity ulcers: a double-blind randomised-controlled trial. Eur J Vasc Endovasc Surg 25:513–518CrossRefPubMedGoogle Scholar
  8. 8.
    Londahl M, Katzman P, Nilsson A, Hammarlund C (2010) Hyperbaric oxygen therapy facilitates healing of chronic foot ulcers in patients with diabetes. Diabetes Care 33:998–1003CrossRefPubMedPubMedCentralGoogle Scholar
  9. 9.
    Ma L, Li P, Shi Z, Hou T, Chen X, Du J (2013) A prospective, randomized, controlled study of hyperbaric oxygen therapy: effects on healing and oxidative stress of ulcer tissue in patients with a diabetic foot ulcer. Ostomy Wound Manage 59:18–24PubMedGoogle Scholar
  10. 10.
    Kessler L, Bilbault P, Ortega F, Grasso C, Passemard R, Stephan D et al (2003) Hyperbaric oxygenation accelerates the healing rate of nonischemic chronic diabetic foot ulcers: a prospective randomized study. Diabetes Care 26:2378–2382CrossRefPubMedGoogle Scholar
  11. 11.
    Doctor N, Pandya S, Supe A (1992) Hyperbaric oxygen therapy in diabetic foot. J Postgrad Med 38(112–114):111Google Scholar
  12. 12.
    Hunt DL (2011) Diabetes: foot ulcers and amputations. BMJ Clin Evid 08:602Google Scholar
  13. 13.
    Londahl M, Landin-Olsson M, Katzman P (2011) Hyperbaric oxygen therapy improves health-related quality of life in patients with diabetes and chronic foot ulcer. Diabet Med 28:186–190CrossRefPubMedGoogle Scholar
  14. 14.
    Kranke P, Bennett MH, Martyn-St James M, Schnabel A, Debus SE, Weibel S (2015) Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev. doi: 10.1002/14651858.CD004123.pub4 Google Scholar
  15. 15.
    Stoekenbroek RM, Santema TB, Legemate DA, Ubbink DT, van den Brink A, Koelemay MJ (2014) Hyperbaric oxygen for the treatment of diabetic foot ulcers: a systematic review. Eur J Vasc Endovasc Surg 47:647–655CrossRefPubMedGoogle Scholar
  16. 16.
    Fedorko L, Bowen JM, Jones W, Oreopoulos G, Goeree R, Hopkins RB et al (2016) Hyperbaric oxygen therapy does not reduce indications for amputation in patients with diabetes with nonhealing ulcers of the lower limb: a prospective, double-blind, randomized controlled clinical trial. Diabetes Care 39:392–399CrossRefPubMedGoogle Scholar
  17. 17.
    O’Reilly D, Linden R, Fedorko L, Tarride JE, Jones WG, Bowen JM et al (2011) A prospective, double-blind, randomized, controlled clinical trial comparing standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care only for the treatment of chronic, non-healing ulcers of the lower limb in patients with diabetes mellitus: a study protocol. Trials 12:69CrossRefPubMedPubMedCentralGoogle Scholar
  18. 18.
    Wagner FW Jr (1981) The dysvascular foot: a system for diagnosis and treatment. Foot Ankle 2:64–122CrossRefPubMedGoogle Scholar
  19. 19.
    Harris C, Bates-Jensen B, Parslow N, Raizman R, Singh M, Ketchen R (2010) Bates-Jensen wound assessment tool: pictorial guide validation project. J Wound Ostomy Continence Nurs 37:253–259CrossRefPubMedGoogle Scholar
  20. 20.
    EuroQol Group (1990) EuroQol–a new facility for the measurement of health-related quality of life. Health Policy 16:199–208 CrossRefGoogle Scholar
  21. 21.
    Brooks R (1996) EuroQol: the current state of play. Health Policy 37:53–72CrossRefPubMedGoogle Scholar
  22. 22.
    Bansback N, Tsuchiya A, Brazier J, Anis A (2012) Canadian valuation of EQ-5D health states: preliminary value set and considerations for future valuation studies. PLoS ONE 7:e31115CrossRefPubMedPubMedCentralGoogle Scholar
  23. 23.
    Ware JE Jr, Sherbourne CD (1992) The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30:473–483CrossRefPubMedGoogle Scholar
  24. 24.
    Bann CM, Fehnel SE, Gagnon DD (2003) Development and validation of the diabetic foot ulcer scale-short form (DFS-SF). PharmacoEconomics 21:1277–1290CrossRefPubMedGoogle Scholar
  25. 25.
    Londahl M (2013) Hyperbaric oxygen therapy as adjunctive treatment of diabetic foot ulcers. Med Clin North Am 97:957–980CrossRefPubMedGoogle Scholar
  26. 26.
    Armstrong DG, Lavery LA, Wrobel JS, Vileikyte L (2008) Quality of life in healing diabetic wounds: does the end justify the means? J Foot Ankle Surg 47:278–282CrossRefPubMedGoogle Scholar
  27. 27.
    Bender R, Lange S (2001) Adjusting for multiple testing–when and how? J Clin Epidemiol 54:343–349CrossRefPubMedGoogle Scholar
  28. 28.
    Li G, Taljaard M, Van den Heuvel ER, Levine MA, Cook DJ, Wells GA, et al (2016) An introduction to multiplicity issues in clinical trials: the what, why, when and how. Int J Epidemiol. doi: 10.1093/ije/dyw320
  29. 29.
    Larsson D, Lager I, Nilsson PM (1999) Socio-economic characteristics and quality of life in diabetes mellitus-relation to metabolic control. Scand J Soc Med 27:101–105CrossRefGoogle Scholar
  30. 30.
    Wändell PE (2005) Quality of life of patients with diabetes mellitus an overview of research in primary health care in the Nordic countries. Scand J Prim Health Care 23:68–74CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag Italia S.r.l. 2017

Authors and Affiliations

  1. 1.Department of Clinical Epidemiology and BiostatisticsMcMaster UniversityHamiltonCanada
  2. 2.Programs for Assessment of Technology in Health (PATH)Centre for Evaluation of MedicinesHamiltonCanada
  3. 3.St. Joseph’s Healthcare HamiltonMcMaster UniversityHamiltonCanada
  4. 4.Department of MedicineMcMaster UniversityHamiltonCanada
  5. 5.Toronto General HospitalUniversity Health NetworkTorontoCanada

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