Meta-analyses of randomized controlled trials reporting the effect of home foot temperature monitoring, patient education or offloading footwear on the incidence of diabetes-related foot ulcers
C. Alahakoon
Ulcer and Wound Healing Consortium (UHEAL), Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Townsville, Australia
Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka
Search for more papers by this authorM. Fernando
Ulcer and Wound Healing Consortium (UHEAL), Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Townsville, Australia
Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Australia
Search for more papers by this authorC. Galappaththy
Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka
Department of Vascular and Endovascular Surgery, Townsville Hospital, Townsville, Australia
Search for more papers by this authorE. O. Matthews
Ulcer and Wound Healing Consortium (UHEAL), Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Townsville, Australia
Search for more papers by this authorP. Lazzarini
School of Public Health and Social Work, Queensland University of Technology, Brisbane, Australia
Allied Health Research Collaborative, Metro North Hospital and Health Service, Brisbane, Queensland, Australia
Search for more papers by this authorJ. V. Moxon
Ulcer and Wound Healing Consortium (UHEAL), Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Townsville, Australia
Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Australia
Search for more papers by this authorCorresponding Author
J. Golledge
Ulcer and Wound Healing Consortium (UHEAL), Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Townsville, Australia
Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Australia
Department of Vascular and Endovascular Surgery, Townsville Hospital, Townsville, Australia
Correspondence to: Jonathan Golledge. E-mail: [email protected]
Search for more papers by this authorC. Alahakoon
Ulcer and Wound Healing Consortium (UHEAL), Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Townsville, Australia
Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka
Search for more papers by this authorM. Fernando
Ulcer and Wound Healing Consortium (UHEAL), Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Townsville, Australia
Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Australia
Search for more papers by this authorC. Galappaththy
Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka
Department of Vascular and Endovascular Surgery, Townsville Hospital, Townsville, Australia
Search for more papers by this authorE. O. Matthews
Ulcer and Wound Healing Consortium (UHEAL), Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Townsville, Australia
Search for more papers by this authorP. Lazzarini
School of Public Health and Social Work, Queensland University of Technology, Brisbane, Australia
Allied Health Research Collaborative, Metro North Hospital and Health Service, Brisbane, Queensland, Australia
Search for more papers by this authorJ. V. Moxon
Ulcer and Wound Healing Consortium (UHEAL), Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Townsville, Australia
Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Australia
Search for more papers by this authorCorresponding Author
J. Golledge
Ulcer and Wound Healing Consortium (UHEAL), Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Townsville, Australia
Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Australia
Department of Vascular and Endovascular Surgery, Townsville Hospital, Townsville, Australia
Correspondence to: Jonathan Golledge. E-mail: [email protected]
Search for more papers by this authorAbstract
Aim
The aim of this study was to perform an up-to-date systematic review and meta-analysis of randomized controlled trials (RCTs) examining the efficacy of home foot temperature monitoring, patient education and offloading footwear in reducing the incidence of diabetes-related foot ulcers.
Methods
A literature search was performed using MEDLINE, PubMed, CINAHL, Scopus and Cochrane databases to identify relevant original studies. Meta-analyses were performed using intention-to-treat principals for worst (main analysis) and best (sub-analysis) case scenarios. Leave-one-out sensitivity analyses were used to assess the consistency of findings.
Results
Of 7575 unique records, 17 RCTs involving 2729 participants were included. Four tested home foot temperature monitoring (n = 468), six examined patient education (n = 823) and seven assessed offloading footwear (n = 1438). Participants’ who performed home foot temperature monitoring [odds ratio (OR) 0.51, 95% confidence interval (CI) 0.31 to 0.84; n = 468] and those provided offloading footwear (OR 0.48, 95% CI 0.29 to 0.80; n = 1438) were less likely to develop a diabetes-related foot ulcer. Patient education programmes did not significantly reduce diabetes-related foot ulcer incidence (OR 0.59, 95% CI 0.29 to 1.20; n = 823). Sensitivity analyses suggested that offloading footwear findings were consistent, but home foot temperature findings were dependent on the individual inclusion of one trial. All RCTs had either high or unclear risk of bias.
Conclusion
This meta-analysis suggests that offloading footwear is effective in reducing the incidence of diabetes-related foot ulcers. Home foot temperature monitoring also appears beneficial but larger trials are needed (PROSPERO registration no.: CRD42019135226).
Supporting Information
| Filename | Description |
|---|---|
| dme14323-sup-0001-Supinfo.docxWord document, 1.4 MB |
Doc S1. Search terms. Figure S1. Forest plot of studies looking at home foot temperature monitoring in prevention of diabetic foot ulcers (best case scenario). Figure S2. Forest plot of studies looking at patient education in prevention of diabetic foot ulcers (best case scenario). Figure S3. Forest plot of studies looking at patient education in prevention of total amputations (minor + major amputations) (worst case scenario). Figure S4. Forest plot of studies looking at patient education in prevention of major amputations (worst case scenario). Figure S5. Forest plot of studies looking at patient education in prevention of minor amputations (worst case scenario). Figure S6. Forest plot of studies looking at offloading footwear in prevention of diabetic foot ulcers (best case scenario). Figure S7. Forest plot of subgroup analysis of studies looking at custom made offloading orthoses/footwear in prevention of diabetic foot ulcers (worst case scenario). Figure S8. Funnel plot of studies looking at home foot temperature monitoring in prevention of diabetic foot ulcers (worst case scenario). Figure S9. Funnel plot of studies looking at patient education in prevention of diabetic foot ulcers (worst case scenario). Figure S10. Funnel plot of studies looking at offloading footwear in prevention of diabetic foot ulcers (worst case scenario). Table S1. Relative risks of the meta-analyses. Table S2. Study characteristics. Table S3. Quality assessment using the Cochrane tool. Table S4. Best-case and worst-case data extraction of diabetic foot ulcers. Table S5. Best-case and worst-case data extraction of amputation data (minor/major/total amputations) from patient education trials. Table S6. Home monitoring of foot temperature. Table S7. Patient education. Table S8. Offloading footwear. |
Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
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