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Flow chart of study selection.
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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.
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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.
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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).
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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).
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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).
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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).
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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.
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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).

Figuras y tablas -
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]

Figuras y tablas -
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

Figuras y tablas -
Comparison 2. Phototherapy versus high‐voltage pulsed current