Compared with not using compression, compression therapy that uses bandages or stockings to treat venous leg ulcers:
- probably heals venous leg ulcers more quickly;
- probably increases the number of people whose ulcer has completely healed after 12 months;
- probably reduces pain; and
- may improve some aspects of people’s quality of life.
However, there is still uncertainty about whether or not compression therapy causes unwanted side effects, and if the health benefits of using compression outweigh its cost.
What are leg ulcers?
Leg ulcers are open skin wounds on the lower leg that can last weeks, months or even years. Most leg ulcers are caused by venous diseases that affect the circulation of blood in leg veins. Venous leg ulcers can cause distress and pain to patients, and can be very costly to the health service.
What did we want to find out?
Standard treatment options for venous leg ulcers often include compression therapy. This involves applying external pressure around the lower leg to help the return of blood from the legs to the heart. Compression therapy uses bandages, stockings or other devices.
We wanted to find out if compression therapy delivered by bandages and stockings compared with no compression:
- heals venous leg ulcers;
- has any unwanted effects;
- improves people’s quality of life;
- has health benefits that outweigh the costs (cost-effectiveness); and
- reduces pain.
What did we do?
We searched for randomised controlled trials (clinical studies where the treatment or care people receive is chosen at random). This type of study design provides the most reliable health evidence about the effects of a treatment. We searched for studies that evaluated the effects of any types of compression bandages or stockings compared with no compression in people affected with venous leg ulcers in any care setting. We compared and summarised their results, and rated our confidence in the evidence, based on factors such as study methods and sizes.
What did we find?
We found 14 studies (1391 people, average age: 70.1 years) that lasted on average for 12 weeks. People in eight of the 14 studies were treated in outpatient and community settings. People had venous leg ulcers that had lasted for 22 months on average, and most ulcers had an area between 5 and 20 cm2.
The studies used three types of compression therapy: short-stretch bandage, four-layer compression bandage, and Unna's boot (a type of compression bandage containing zinc oxide). These therapies were compared with no compression in forms of 'usual care', pharmacological treatment, a variety of dressings, and a variety of treatments where only some participants received compression (but it was not the norm).
(1) Venous leg-ulcer healing and unwanted effects
Compared with no compression, the evidence suggests that:
- people wearing compression bandages or stockings probably experience complete ulcer healing more quickly; and
- more people treated using the compression bandages or stockings are likely to experience complete ulcer healing within 12 months.
However, we did not find clear evidence to tell if using compression bandages or stockings causes any unwanted effects.
(2) Other effects
The evidence suggests that, compared with not using compression, the use of compression bandages or stockings:
- probably reduces pain more than not using compression; and
- may improve some aspects of people’s quality of life in 12 weeks to 12 months.
However, we are uncertain if the use of compression bandages or stockings results in health benefits that outweigh their costs.
What limited our confidence in the evidence?
Most studies were small (51 people on average) and 10 of the 14 included studies used methods that could introduce errors in their results.
How up-to-date is this review?
The evidence in this Cochrane Review is current to June 2020.
If using compression bandages or stockings, people with venous leg ulcers probably experience complete wound healing more quickly, and more people have wounds completely healed. The use of compression bandages or stockings probably reduces pain and may improve disease-specific quality of life. There is uncertainty about adverse effects, and cost effectiveness.
Future research should focus on comparing alternative bandages and stockings with the primary endpoint of time to complete wound healing alongside adverse events including pain score, and health-related quality of life, and should incorporate cost-effectiveness analysis where possible. Future studies should adhere to international standards of trial conduct and reporting.
Leg ulcers are open skin wounds on the lower leg that can last weeks, months or even years. Most leg ulcers are the result of venous diseases. First-line treatment options often include the use of compression bandages or stockings.
To assess the effects of using compression bandages or stockings, compared with no compression, on the healing of venous leg ulcers in any setting and population.
In June 2020 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 scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions by language, date of publication or study setting.
We included randomised controlled trials that compared any types of compression bandages or stockings with no compression in participants with venous leg ulcers in any setting.
At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, and risk-of-bias assessment using the Cochrane risk-of-bias tool. We assessed the certainty of the evidence according to GRADE methodology.
We included 14 studies (1391 participants) in the review. Most studies were small (median study sample size: 51 participants). Participants were recruited from acute-care settings, outpatient settings and community settings, and a large proportion (65.9%; 917/1391) of participants had a confirmed history or clinical evidence of chronic venous disease, a confirmed cause of chronic venous insufficiency, or an ankle pressure/brachial pressure ratio of greater than 0.8 or 0.9. The average age of participants ranged from 58.0 to 76.5 years (median: 70.1 years). The average duration of their leg ulcers ranged from 9.0 weeks to 31.6 months (median: 22.0 months), and a large proportion of participants (64.8%; 901/1391) had ulcers with an area between 5 and 20 cm2. Studies had a median follow-up of 12 weeks. Compression bandages or stockings applied included short-stretch bandage, four-layer compression bandage, and Unna's boot (a type of inelastic gauze bandage impregnated with zinc oxide), and comparator groups used included 'usual care', pharmacological treatment, a variety of dressings, and a variety of treatments where some participants received compression (but it was not the norm). Of the 14 included studies, 10 (71.4%) presented findings which we consider to be at high overall risk of bias.
There is moderate-certainty evidence (downgraded once for risk of bias) (1) that there is probably a shorter time to complete healing of venous leg ulcers in people wearing compression bandages or stockings compared with those not wearing compression (pooled hazard ratio for time-to-complete healing 2.17, 95% confidence interval (CI) 1.52 to 3.10; I2 = 59%; 5 studies, 733 participants); and (2) that people treated using compression bandages or stockings are more likely to experience complete ulcer healing within 12 months compared with people with no compression (10 studies, 1215 participants): risk ratio for complete healing 1.77, 95% CI 1.41 to 2.21; I2 = 65% (8 studies with analysable data, 1120 participants); synthesis without meta-analysis suggests more completely-healed ulcers in compression bandages or stockings than in no compression (2 studies without analysable data, 95 participants).
It is uncertain whether there is any difference in rates of adverse events between using compression bandages or stockings and no compression (very low-certainty evidence; 3 studies, 585 participants).
Moderate-certainty evidence suggests that people using compression bandages or stockings probably have a lower mean pain score than those not using compression (four studies with 859 participants and another study with 69 ulcers): pooled mean difference −1.39, 95% CI −1.79 to −0.98; I2 = 65% (two studies with 426 participants and another study with 69 ulcers having analysable data); synthesis without meta-analysis suggests a reduction in leg ulcer pain in compression bandages or stockings, compared with no compression (two studies without analysable data, 433 participants). Compression bandages or stockings versus no compression may improve disease-specific quality of life, but not all aspects of general health status during the follow-up of 12 weeks to 12 months (four studies with 859 participants; low-certainty evidence).
It is uncertain if the use of compression bandages or stockings is more cost-effective than not using them (three studies with 486 participants; very low-certainty evidence).