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06-12-2017 | Diabetic foot | Article

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

Journal: Acta Diabetologica

Authors: Guowei Li, Robert B. Hopkins, Mitchell A. H. Levine, Xuejing Jin, James M. Bowen, Lehana Thabane, Ron Goeree, Ludwik Fedorko, Daria J. O’Reilly

Publisher: Springer Milan

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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.
Literature
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 15:13 CrossRefPubMedPubMedCentral
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 32:368–377 CrossRefPubMed
3.
Rubin RR, Peyrot M (1999) Quality of life and diabetes. Diabetes Metab Res Rev 15:205–218 CrossRefPubMed
4.
Simo R, Hernandez C (2002) [Treatment of diabetes mellitus: general goals, and clinical practice management]. Rev Esp Cardiol 55:845–860 CrossRefPubMed
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–e173 CrossRefPubMed
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) CrossRef
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 25:513–518 CrossRefPubMed
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 33:998–1003 CrossRefPubMedPubMedCentral
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 59:18–24 PubMed
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 26:2378–2382 CrossRefPubMed
11.
Doctor N, Pandya S, Supe A (1992) Hyperbaric oxygen therapy in diabetic foot. J Postgrad Med 38(112–114):111
12.
Hunt DL (2011) Diabetes: foot ulcers and amputations. BMJ Clin Evid 08:602
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 28:186–190 CrossRefPubMed
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
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 47:647–655 CrossRefPubMed
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 39:392–399 CrossRefPubMed
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 12:69 CrossRefPubMedPubMedCentral
18.
Wagner FW Jr (1981) The dysvascular foot: a system for diagnosis and treatment. Foot Ankle 2:64–122 CrossRefPubMed
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 37:253–259 CrossRefPubMed
20.
EuroQol Group (1990) EuroQol–a new facility for the measurement of health-related quality of life. Health Policy 16:199–208 CrossRef
21.
Brooks R (1996) EuroQol: the current state of play. Health Policy 37:53–72 CrossRefPubMed
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:e31115 CrossRefPubMedPubMedCentral
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 30:473–483 CrossRefPubMed
24.
Bann CM, Fehnel SE, Gagnon DD (2003) Development and validation of the diabetic foot ulcer scale-short form (DFS-SF). PharmacoEconomics 21:1277–1290 CrossRefPubMed
25.
Londahl M (2013) Hyperbaric oxygen therapy as adjunctive treatment of diabetic foot ulcers. Med Clin North Am 97:957–980 CrossRefPubMed
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 47:278–282 CrossRefPubMed
27.
Bender R, Lange S (2001) Adjusting for multiple testing–when and how? J Clin Epidemiol 54:343–349 CrossRefPubMed
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.
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 27:101–105 CrossRef
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 23:68–74 CrossRefPubMed

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