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Meta-Analysis
. 2017 May 15;5(5):CD001180.
doi: 10.1002/14651858.CD001180.pub4.

Therapeutic ultrasound for venous leg ulcers

Nicky Cullum  1   2 , Zhenmi Liu  1
Affiliations
Meta-Analysis

Therapeutic ultrasound for venous leg ulcers

Nicky Cullum et al. Cochrane Database Syst Rev. .

Abstract

Background: Venous leg ulcers are a type of chronic, recurring, complex wound that is more common in people aged over 65 years. Venous ulcers pose a significant burden to patients and healthcare systems. While compression therapy (such as bandages or stockings) is an effective first-line treatment, ultrasound may have a role to play in healing venous ulcers.

Objectives: To determine whether venous leg ulcers treated with ultrasound heal more quickly than those not treated with ultrasound.

Search methods: We searched the Cochrane Wounds Specialised Register (searched 19 September 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library 2016, Issue 8); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations, MEDLINE Daily and Epub Ahead of Print) (1946 to 19 September 2016); Ovid Embase (1974 to 19 September 2016); and EBSCO CINAHL Plus (1937 to 19 September 2016). We also searched three clinical trials registries and the references of included studies and relevant systematic reviews. There were no restrictions based on language, date of publication or study setting.

Selection criteria: Randomised controlled trials (RCTs) that compared ultrasound with no ultrasound. Eligible non-ultrasound comparator treatments included usual care, sham ultrasound and alternative leg ulcer treatments.

Data collection and analysis: Two authors independently assessed the search results and selected eligible studies. Details from included studies were summarised using a data extraction sheet, and double-checked. We attempted to contact trial authors for missing data.

Main results: Eleven trials are included in this update; 10 of these we judged to be at an unclear or high risk of bias. The trials were clinically heterogeneous with differences in duration of follow-up, and ultrasound regimens. Nine trials evaluated high frequency ultrasound; seven studies provided data for ulcers healed and two provided data on change in ulcer size only. Two trials evaluated low frequency ultrasound and both reported ulcers healed data.It is uncertain whether high frequency ultrasound affects the proportion of ulcers healed compared with no ultrasound at any of the time points evaluated: at seven to eight weeks (RR 1.21, 95% CI 0.86 to 1.71; 6 trials, 678 participants; low quality evidence - downgraded once for risk of bias and once for imprecision); at 12 weeks (RR 1.26, 95% CI 0.92 to 1.73; 3 trials, 489 participants; moderate quality evidence - downgraded once for imprecision); and at 12 months (RR 0.93, 95% CI 0.73 to 1.18; 1 trial, 337 participants; low quality evidence - downgraded once for unclear risk of bias and once for imprecision).One trial (92 participants) reported that a greater percentage reduction in ulcer area was achieved at four weeks with high-frequency ultrasound, while another (73 participants) reported no clear difference in change in ulcer size at seven weeks. We downgraded the level of this evidence to very low, mainly for risk of bias (typically lack of blinded outcome assessment and attrition) and imprecision.Data from one trial (337 participants) suggest that high frequency ultrasound may increase the risk of non-serious adverse events (RR 1.29, 95% CI 1.02 to 1.64; moderate quality evidence - downgraded once for imprecision) and serious adverse events (RR 1.21, 95% CI 0.78 to 1.89; moderate quality evidence downgraded once for imprecision).It is uncertain whether low frequency ultrasound affects venous ulcer healing at eight and 12 weeks (RR 3.91, 95% CI 0.47 to 32.85; 2 trials, 61 participants; very low quality evidence (downgraded for risk of bias and imprecision)).High-frequency ultrasound probably makes little or no difference to quality of life (moderate quality evidence, downgraded for imprecision). The outcomes of adverse effects, quality of life and cost were not reported for low-frequency ultrasound treatment.

Authors' conclusions: It is uncertain whether therapeutic ultrasound (either high or low frequency) improves the healing of venous leg ulcers. We rated most of the evidence as low or very low quality due to risk of bias and imprecision.

PubMed Disclaimer

Conflict of interest statement

Nicky Cullum was a co investigator of one of the studies that is included in this review (Watson 2011). The data extraction and risk of bias assessment for this study was conducted by another reviewer and checked by an independent member of the editorial staff. Nicky Cullum was not involved in signing this review off for publication. Nicky Cullum receives research funding for wounds‐related research and systematic reviews from the NIHR.

Zhenmi Liu's employment at the University of Manchester is funded by NIHR (NIHR Research Methods Programme Systematic Review Fellowship NIHR‐RMFI‐2015‐06‐52).

Figures

1
1
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
2
2
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
3
3
Study flow diagram
1.1
1.1. Analysis
Comparison 1 High frequency US vs no US, Outcome 1 Proportion of ulcers completely healed at 3 weeks.
1.2
1.2. Analysis
Comparison 1 High frequency US vs no US, Outcome 2 Proportion of ulcers completely healed at 7 or 8 weeks.
1.3
1.3. Analysis
Comparison 1 High frequency US vs no US, Outcome 3 Proportion of ulcers completely healed at 12 weeks.
1.4
1.4. Analysis
Comparison 1 High frequency US vs no US, Outcome 4 Proportion of ulcers completely healed at 12 months (nurse‐reported data).
1.5
1.5. Analysis
Comparison 1 High frequency US vs no US, Outcome 5 HRQoL: 12‐week SF‐12 Physical Component Score.
1.6
1.6. Analysis
Comparison 1 High frequency US vs no US, Outcome 6 HRQoL: 12‐week SF‐12 Mental Component Score.
1.7
1.7. Analysis
Comparison 1 High frequency US vs no US, Outcome 7 HRQoL: 12‐month SF‐12 Physical Component Score.
1.8
1.8. Analysis
Comparison 1 High frequency US vs no US, Outcome 8 HRQoL: 12‐month SF‐12 Mental Component Score.
1.9
1.9. Analysis
Comparison 1 High frequency US vs no US, Outcome 9 Non‐serious and serious adverse events.
2.1
2.1. Analysis
Comparison 2 Low frequency US vs no US, Outcome 1 Proportion of ulcers completely healed at 8‐12 weeks.
See this image and copyright information in PMC

Update of

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