Key messages
Compared with compression treatment alone, or compression with endovenous treatment (but delayed until after an ulcer has healed):
- endovenous ablation and compression together reduce time to complete ulcer healing;
- endovenous treatment and compression together probably increase the proportion of ulcers healed at 90 days;
- combined endovenous treatment and compression may not change ulcer recurrence or the number of ulcer-free days at one year.
Further research is needed into:
- the effects of endovenous ablation for chronic (long-term) ulcers;
- how effective different endovenous ablation techniques are.
What are venous leg ulcers?
Venous leg ulcers (VLUs) are open sores below the knee that are caused by chronic venous disease.
Veins in the calf normally pump blood back towards the heart. Valves in these veins prevent the blood from flowing back down the leg. If these valves fail, pressure can increase in the leg, which can lead to inflammation, skin breakdown and ulcer formation.
Venous leg ulcers take a long time to heal and often reoccur. This significantly impairs quality of life, and treating VLUs places a heavy financial burden upon healthcare systems.
How are venous leg ulcers treated?
Venous leg ulcers are usually treated with compression therapy. This involves wearing socks or stockings that help to increase blood flow in the legs.
Problematic veins can also be surgically removed. However, this is not a popular option amongst patients, and many people are not able to have this kind of surgery due to other medical problems.
Endovenous ablation is a newer, minimally-invasive technique that treats venous disease by blocking certain veins. Medication is injected into the vein, or a device is inserted into the vein and then heated up to permanently close it.
Endovenous ablation combined with compression therapy aims to further reduce pressure in the veins of the leg, which may impact ulcer healing.
What did we want to find out?
We wanted to find out if endovenous ablation combined with compression therapy:
- helps to heal VLUs;
- prevents VLUs from reoccurring;
- improves quality of life;
- is cost-effective;
- was associated with any unwanted effects.
What did we do?
We searched for studies that looked at endovenous ablation with compression therapy versus compression therapy alone for treating VLUs. There were no restrictions on the publication language.
We compared and summarised the studies’ results and rated our confidence in the evidence, based on factors such as study methods and sizes.
What did we find?
In our original review we did not find any eligible studies. In this update we found two new relevant studies. We found one UK study with 450 participants and one Brazilian study with 56 participants.
Compared with compression therapy alone, or compression with deferred endovenous treatment:
- combined endovenous ablation and compression improves time to complete ulcer healing;
- combined endovenous treatment and compression probably improves the proportion of ulcers healed at 90 days;
- combined endovenous treatment and compression may not have an effect on ulcer recurrence at one year or the number of ulcer-free days at one year;
- combined endovenous treatment and compression is probably cost-effective at one year;
- combined endovenous treatment and compression may not have an effect on blood clots (venous thromboembolism).
What are the limitations of the evidence?
The majority of the participants had an ulcer for less than six months. Although the results were similar in those with longer-term ulcers, further research is required to confirm this.
This review did not find any studies which assessed whether some techniques of endovenous ablation are more effective than others for people with venous leg ulcers.
How up to date is this evidence?
This review updates our previous review. The evidence is up to date to April 2022.
Endovenous ablation of superficial venous incompetence in combination with compression improves leg ulcer healing when compared with compression alone. This conclusion is based on high-certainty evidence. There is moderate-certainty evidence to suggest that it is probably cost-effective at one year and low certainty evidence of unclear effects on recurrence and complications. Further research is needed to explore the additional benefit of endovenous ablation in ulcers of greater than six months duration and the optimal modality of endovenous ablation.
Venous leg ulcers (VLUs) are a serious manifestation of chronic venous disease affecting up to 3% of the adult population. This typically recalcitrant and recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The longstanding mainstay treatment for VLUs is compression therapy. Surgical removal of incompetent veins reduces the risk of ulcer recurrence. However, open surgery is an unpopular option amongst people with VLU, and many people are unsuitable for it. The efficacy of the newer, minimally-invasive endovenous techniques has been established in uncomplicated superficial venous disease, and these techniques can also be used in the management of VLU. When used with compression, endovenous ablation aims to further reduce pressure in the veins of the leg, which may impact ulcer healing.
To determine the effects of superficial endovenous ablation on the healing and recurrence of venous leg ulcers and the quality of life of people with venous ulcer disease.
In April 2022 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scrutinised reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions on the language of publication, but there was a restriction on publication year from 1998 to April 2022 as superficial endovenous ablation is a comparatively new technology.
Randomised controlled trials (RCTs) comparing endovenous ablative techniques with compression versus compression therapy alone for the treatment of VLU were eligible for inclusion. Studies needed to have assessed at least one of the following primary review outcomes related to objective measures of ulcer healing such as: proportion of ulcers healed at a given time point; time to complete healing; change in ulcer size; proportion of ulcers recurring over a given time period or at a specific point; or ulcer-free days. Secondary outcomes of interest were patient-reported quality of life, economic data and adverse events.
Two reviewers independently assessed studies for eligibility, extracted data, carried out risk of bias assessment using the Cochrane RoB 1 tool, and assessed GRADE certainty of evidence.
The previous version of this review found no RCTs meeting the inclusion criteria. In this update, we identified two eligible RCTs and included them in a meta-analysis. There was a total of 506 participants with an active VLU, with mean durations of 3.1 months ± 1.1 months in the EVRA trial and 60.5 months ± 96.4 months in the VUERT trial. Both trials randomised participants to endovenous treatment and compression or compression alone, however the compression alone group in the EVRA trial received deferred endovenous treatment (after ulcer healing or from six months).
There is high-certainty evidence that combined endovenous ablation and compression compared with compression therapy alone, or compression with deferred endovenous treatment, improves time to complete ulcer healing (pooled hazard ratio (HR) 1.41, 95% CI 1.36 to 1.47; I2 = 0%; 2 studies, 466 participants). There is moderate-certainty evidence that the proportion of ulcers healed at 90 days is probably higher with combined endovenous ablation and compression compared with compression therapy alone or compression with deferred endovenous treatment (risk ratio (RR) 1.14, 95% CI 1.00 to 1.30; I2 = 0%; 2 studies, 466 participants). There is low-certainty evidence showing an unclear effect on ulcer recurrence at one year in people with healed ulcers with combined endovenous treatment and compression when compared with compression alone or compression with deferred endovenous treatment (RR 0.29, 95% CI 0.03 to 2.48; I2 = 78%; 2 studies, 460 participants). There is also low-certainty evidence that the median number of ulcer-free days at one year may not differ (306 (interquartile range (IQR) 240 to 328) days versus 278 (IQR 175 to 324) days) following combined endovenous treatment and compression when compared with compression and deferred endovenous treatment; (1 study, 450 participants).
There is low-certainty evidence of an unclear effect in rates of thromboembolism between groups (RR 2.02, 95% CI 0.51 to 7.97; I2 = 78%, 2 studies, 506 participants). The addition of endovenous ablation to compression is probably cost-effective at one year (99% probability at GBP 20,000/QALY; 1 study; moderate-certainty evidence).