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Cochrane Database of Systematic Reviews

Phototherapy for treating foot ulcers in people with diabetes

Information

DOI:
https://doi.org/10.1002/14651858.CD011979.pub2Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 28 June 2017see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Wounds Group

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Hong‐Tao Wang

    Burns Centre of PLA, Department of Burns and Cutaneous Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China

  • Jin‐Qiu Yuan

    Division of Epidemiology, The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China

  • Bin Zhang

    Department of Dermatology and Venereology, Xinqiao Hospital, Third Military Medical University, Chongqing, China

  • Mao‐Long Dong

    Burns Centre of PLA, Department of Burns and Cutaneous Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China

  • Chen Mao

    Division of Epidemiology, The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China

  • Dahai Hu

    Correspondence to: Burns Centre of PLA, Department of Burns and Cutaneous Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China

    [email protected]

Contributions of authors

Hong‐Tao Wang: conceived and designed the review; extracted data; checked the quality of data extraction; undertook and checked quality assessment; produced the first draft of the review; secured funding and approved the final review prior to submission.

Jin‐Qiu Yuan: extracted data; checked the quality of data extraction; analysed or interpreted data; undertook and checked quality assessment; performed statistical analysis; contributed to writing and editing the review; made an intellectual contribution to the review; advised on the review and approved the final review prior to submission.

Bin Zhang: contributed to writing and editing the review; made an intellectual contribution to the review; advised on the review and approved the final review prior to submission.

Mao‐Long Dong: contributed to writing and editing the review; made an intellectual contribution to the review; advised on the review and approved the final review prior to submission.

Chen Mao: checked the quality of the statistical analysis; contributed to writing and editing the review; made an intellectual contribution to the review; advised on the review and approved the final review prior to submission.

Da‐Hai Hu: conceived, designed and coordinated the review; undertook and checked quality assessment; checked the quality of the statistical analysis; contributed to writing and editing the review; wrote to study author / experts / companies; approved the final review prior to submission and is a guarantor of the review.

Contributions of the editorial base

Jo Dumville and Nicky Cullum (Editors): edited the protocol; advised on methodology, interpretation, and protocol content; approved the final protocol prior to submission.

Kurinchi Gurusamy (Editor): edited the review; advised on methodology, interpretation, and review content; approved the final review prior to submission.

Gill Rizzello (Managing Editor): co‐ordinated the editorial process; advised on content; edited the protocol and the review.

Reetu Child and Naomi Shaw (Information Specialists): designed the search strategy, ran the searches, and edited the search methods section.

Ursula Gonthier (Editorial Assistant): edited the plain language summary and reference sections.

Sources of support

Internal sources

  • Natural Science Funds of Shaanxi Province China (2014JM4180), China.

External sources

  • This project was supported by the National Institute for Health Research (NIHR), via Cochrane Infrastructure funding to Cochrane Wounds. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, National Health Service (NHS), or the Department of Health, UK.

Declarations of interest

Hong‐Tao Wang: none known.

Jin‐Qiu Yuan: none known.

Bin Zhang: none known.

Mao‐Long Dong: none known.

Chen Mao: none known.

Da‐Hai Hu: none known.

Acknowledgements

The review authors would like to thank peer referees Susan O'Meara, Zipporah Iheozor‐Ejiofor, Gill Worthy, Nicolette Houreld and Brian Stafford for their comments on the review. Thanks are also due to peer referees Andrea Nelson, Caroline Main, Lukas Schmuelling, Odie Geiger and Jane Nadel who provided feedback on the protocol. The authors are grateful to copy editor Lisa Winer for her comments and assistance with this review.

Version history

Published

Title

Stage

Authors

Version

2017 Jun 28

Phototherapy for treating foot ulcers in people with diabetes

Review

Hong‐Tao Wang, Jin‐Qiu Yuan, Bin Zhang, Mao‐Long Dong, Chen Mao, Dahai Hu

https://doi.org/10.1002/14651858.CD011979.pub2

2015 Nov 29

Phototherapy for treating foot ulcers in people with diabetes

Protocol

Hong‐Tao Wang, Jin‐Qiu Yuan, Bin Zhang, Mao‐Long Dong, Chen Mao, Da‐Hai Hu

https://doi.org/10.1002/14651858.CD011979

Differences between protocol and review

Ulcer aetiology is a source of clinical heterogeneity we considered in the final review but did not state in the protocol.

In the protocol we planned to compare different forms of phototherapy and phototherapy of different output power, wavelength, power density, or dose range; however, as we did not identify any eligible studies reporting these comparisons, we did not carry out analyses for them.

Regarding unit of analysis issues, in the protocol we intended to combine effect estimates and their standard errors using the generic inverse‐variance method. If unit of analysis issues had existed and we were unable to adjust for them, we planned to report them as part of the 'Risk of bias' assessment. However, we did not identify any included studies with the aforementioned unit of analysis issues in the final review.

We planned to evaluated publication bias in protocol, but did not do so because the number of included studies was less than 10.

Keywords

MeSH

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Flow chart of study selection.
Figures and Tables -
Figure 1

Flow chart of study selection.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Phototherapy versus no phototherapy/placebo, Outcome 1 Proportion of wounds completely healed during follow‐up (4 to 20 weeks).
Figures and Tables -
Analysis 1.1

Comparison 1 Phototherapy versus no phototherapy/placebo, Outcome 1 Proportion of wounds completely healed during follow‐up (4 to 20 weeks).

Comparison 1 Phototherapy versus no phototherapy/placebo, Outcome 2 Change in ulcer size in relative terms (percentage change in wound area).
Figures and Tables -
Analysis 1.2

Comparison 1 Phototherapy versus no phototherapy/placebo, Outcome 2 Change in ulcer size in relative terms (percentage change in wound area).

Comparison 1 Phototherapy versus no phototherapy/placebo, Outcome 3 Change in ulcer size in absolute terms (mean change in wound area).
Figures and Tables -
Analysis 1.3

Comparison 1 Phototherapy versus no phototherapy/placebo, Outcome 3 Change in ulcer size in absolute terms (mean change in wound area).

Comparison 1 Phototherapy versus no phototherapy/placebo, Outcome 4 Number of amputations at study end (20 weeks).
Figures and Tables -
Analysis 1.4

Comparison 1 Phototherapy versus no phototherapy/placebo, Outcome 4 Number of amputations at study end (20 weeks).

Comparison 2 Phototherapy versus high‐voltage pulsed current, Outcome 1 Proportion of wounds completely healed during follow‐up.
Figures and Tables -
Analysis 2.1

Comparison 2 Phototherapy versus high‐voltage pulsed current, Outcome 1 Proportion of wounds completely healed during follow‐up.

Summary of findings for the main comparison. Phototherapy compared with placebo/no phototherapy for foot ulcers in people with diabetes

Phototherapy compared with placebo/no phototherapy for foot ulcers in people with diabetes

Patient or population: Diabetes with foot ulcers

Settings: Clinics and hospitals

Intervention: Phototherapy

Comparison: Placebo/no phototherapy

Outcomes

Anticipated absolute effects*(95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed absolute effect

Corresponding absolute effect

Placebo/no phototherapy

Phototherapy

Wound healing ‐ time to complete wound healing (weeks)

No study provided reliable data for this outcome.

Wound healing ‐ proportion of wounds completely healed during follow‐up

330 per 1000

568 per 1000
(383 to 845)

RR 1.57

(1.08 to 2.28)

116 (4 studies)

⊕⊕⊝⊝
low¹

Adverse events

See comment

See comment

See comment

See comment

See comment

In Landau 2011, there were no device‐related adverse events. In Londahl 2013, the authors suggested that there was no difference in adverse events between intervention and control groups, but the number of adverse events was not reported.

*The basis for the assumed absolute effect (e.g. the median control group risk across studies) is provided in footnotes. The corresponding absolute effect (and its 95% confidence interval) is based on the assumed absolute effect in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Downgraded one level for study limitations (high risk of bias for incomplete outcome data in two studies and potential influence of imbalance in baseline characteristics in one study) and one level for imprecision (small sample size).

Figures and Tables -
Summary of findings for the main comparison. Phototherapy compared with placebo/no phototherapy for foot ulcers in people with diabetes
Comparison 1. Phototherapy versus no phototherapy/placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of wounds completely healed during follow‐up (4 to 20 weeks) Show forest plot

4

116

Risk Ratio (IV, Fixed, 95% CI)

1.57 [1.08, 2.28]

2 Change in ulcer size in relative terms (percentage change in wound area) Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 Treatment duration (1 week)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Treatment duration (2 weeks)

2

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Treatment duration (3 weeks)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.4 Treatment duration (4 weeks)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Change in ulcer size in absolute terms (mean change in wound area) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

3.1 Treatment duration (2 weeks)

1

68

Mean Difference (IV, Fixed, 95% CI)

720.76 [626.61, 814.91]

4 Number of amputations at study end (20 weeks) Show forest plot

1

23

Risk Ratio (IV, Fixed, 95% CI)

0.16 [0.01, 2.95]

Figures and Tables -
Comparison 1. Phototherapy versus no phototherapy/placebo
Comparison 2. Phototherapy versus high‐voltage pulsed current

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of wounds completely healed during follow‐up Show forest plot

1

Risk Ratio (IV, Fixed, 95% CI)

Totals not selected

Figures and Tables -
Comparison 2. Phototherapy versus high‐voltage pulsed current