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PRISMA flow diagram of literature screening
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Figure 1

PRISMA flow diagram of literature screening

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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.

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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.

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Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 1 Proportion of ulcers completely healed (overall).
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Analysis 1.1

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 1 Proportion of ulcers completely healed (overall).

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Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 2 Proportion of ulcers completely healed (sensitivity analysis).
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Analysis 1.2

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 2 Proportion of ulcers completely healed (sensitivity analysis).

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Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 3 Proportion of ulcers completely healed at 30 days.
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Analysis 1.3

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 3 Proportion of ulcers completely healed at 30 days.

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Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 4 Proportion of ulcers completely healed at 60 days.
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Analysis 1.4

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 4 Proportion of ulcers completely healed at 60 days.

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Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 5 Proportion of ulcers completely healed at 90 days.
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Analysis 1.5

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 5 Proportion of ulcers completely healed at 90 days.

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Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 6 Adverse effects.
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Analysis 1.6

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 6 Adverse effects.

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Summary of findings for the main comparison. Sulodexide + local treatment compared to local treatment for treating venous leg ulcers

Sulodexide + local treatment compared to local treatment for treating venous leg ulcers

Patient or population: patients with venous leg ulcers
Settings: Italy and China
Intervention: Sulodexide + local treatment
Comparison: local treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

local treatment

Sulodexide + local treatment

Proportion of ulcers completely healed (overall)
Follow‐up: 30 to 90 days

298 per 1000

494 per 1000
(387 to 631)

RR 1.66
(1.3 to 2.12)

438
(3 studies)

⊕⊕⊝⊝
low1

Proportion of ulcers completely healed at 30 days
Follow‐up: mean 30 days

189 per 1000

360 per 1000
(189 to 691)

RR 1.91
(1 to 3.66)

114
(1 study)

⊕⊝⊝⊝
very low2

Proportion of ulcers completely healed at 60 days
Follow‐up: mean 60 days

250 per 1000

412 per 1000
(300 to 570)

RR 1.65
(1.2 to 2.28)

324
(2 studies)

⊕⊕⊝⊝
low1

Proportion of ulcers completely healed at 90 days
Follow‐up: mean 90 days

327 per 1000

524 per 1000
(383 to 720)

RR 1.6
(1.17 to 2.2)

230
(1 study)

⊕⊕⊝⊝
low3

Time to complete ulcer healing

Available data were limited and not analysed

Change in absolute ulcer size

Available data were limited and not analysed

Ulcer recurrence

Not reported

Adverse effects
Follow‐up: 30 to 90 days

31 per 1000

44 per 1000
(15 to 133)

RR 1.44
(0.48 to 4.34)

344
(2 studies)

⊕⊝⊝⊝
very low4

Health‐related quality of life

Not reported

Direct costs

Not reported

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

1 Downgraded two levels for risk of bias (risk of selection bias due to lack of allocation concealment; risk of performance bias due to lack of blinding of participants, personnel and outcome assessors).

2 Downgraded two levels for risk of bias (risk of selection bias due to lack of allocation concealment; risk of performance bias due to lack of blinding of participants, personnel and outcome assessors) and one level for imprecision (single study with very wide confidence intervals).

3 Downgraded one level for risk of bias (lack of allocation concealment) and one level for imprecision (single study with very wide confidence intervals).

4 Downgraded two levels for risk of bias (risk of selection bias due to lack of allocation concealment; risk of performance bias due to lack of blinding of participants, personnel and outcome assessors) and one level for imprecision (wide confidence intervals).

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Summary of findings for the main comparison. Sulodexide + local treatment compared to local treatment for treating venous leg ulcers
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Comparison 1. Sulodexide + local treatment vs. local treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of ulcers completely healed (overall) Show forest plot

3

438

Risk Ratio (M‐H, Fixed, 95% CI)

1.66 [1.30, 2.12]

2 Proportion of ulcers completely healed (sensitivity analysis) Show forest plot

3

438

Risk Ratio (M‐H, Fixed, 95% CI)

1.53 [1.27, 1.83]

3 Proportion of ulcers completely healed at 30 days Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4 Proportion of ulcers completely healed at 60 days Show forest plot

2

324

Risk Ratio (M‐H, Fixed, 95% CI)

1.65 [1.20, 2.28]

5 Proportion of ulcers completely healed at 90 days Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

6 Adverse effects Show forest plot

2

344

Risk Ratio (M‐H, Fixed, 95% CI)

1.44 [0.48, 4.34]
Figuras y tablas -
Comparison 1. Sulodexide + local treatment vs. local treatment
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