Endovenous ablation of superficial venous incompetence and compression compared with compression alone for venous leg ulcers

Patient or population: adults with venous leg ulcers.

Settings: outpatient hospital care and/or in community care

Intervention: endovenous ablation of superficial venous incompetence with standard wound care that includes compression

Comparison: standard wound care that includes compression

Ulcer healing time

(measured as days from randomisation and followed‐up to 1 year)

HR 1.41 (1.36 to 1.47)

466

(2 RCTs)

⊕⊕⊕⊕
High

Risk of performance bias in both included studies was high as the nature of the interventions in the treatment groups meant that neither participants nor treating clinicians were blinded at the time treatments were performed. Blinding was not possible in these studies. The outcome was measured by blinded assessors. The outcomes in the control arms were equal to or better than those reported in the independent literature. This increases our confidence that the true effect lies close to that of the estimate of the effect, so we did not downgrade the certainty of evidence.

Proportion of ulcers healed at 90 days

(90 days follow‐up)

RR 1.14 (1.00 to 1.30)

466

(2 RCTs)

⊕⊕⊕⊝
Moderate^a

Proportion of ulcers healed at one year (52 week follow up)

RR 1.08 (1.02 to 1.14 )

505 (2 RCTs)

⊕⊕⊕⊝
Moderate^a

Ulcer recurrence

(1 year follow‐up)

RR 0.29

(0.03 to 2.48)

460

(2 RCTs)

⊕⊕⊕⊝
Low^b

Ulcer‐free time

(measured as days from healing of index ulcer to recurrence)

450

(1 RCT)

⊕⊕⊕⊝
Low^c

Ulcer‐free time was only reported by the EVRA study; it was not possible to calculate an effect estimate. We downgraded the certainty of evidence by two levels due to serious indirectness as the intervention was given to both groups.

*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; HR: hazard ratio; 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.