What was the aim of this review?
We reviewed the evidence about whether or not negative pressure wound therapy (NPWT) is effective in treating foot wounds in people with diabetes. Researchers from Cochrane collected and analysed all relevant studies (randomised controlled trials; clinical studies where people are randomly put into one of two or more treatment groups) to answer this question and found 11 relevant studies.
We cannot be certain whether NPWT is effective for treating foot wounds in people with diabetes. There is some low-certainty evidence that NPWT increases the number of wounds healed compared with dressings, and may reduce the time it takes wounds to heal. We are uncertain about the effectiveness of different pressures of NPWT on wound healing. Overall, the reliability of the evidence provided by the trials is too low for us to be certain of the benefits and harms of NPWT for treating foot wounds in people with diabetes.
What did the review study?
Diabetes mellitus is a common condition that leads to high blood glucose (blood sugar) concentrations, with around 2.8 million people affected in the UK (approximately 4.3% of the population). Some people with diabetes can develop ulcers on their feet. These wounds can take a long time to heal, they can be painful and become infected. Ulceration of the foot in people with diabetes can also lead to a higher risk of amputation of parts of the foot or leg. Generally, people with diabetes are at a higher risk of lower-limb amputation than people without diabetes.
NPWT is a treatment currently being used for wounds including leg ulcers. NPWT involves the application of a wound dressing attached to a vacuum suction machine which sucks any wound and tissue fluid away from the treated area into a canister. Worldwide, the use of NPWT is increasing. However, it is expensive compared with wound treatments such as dressings.
We wanted to find out if NPWT could help foot wounds in people with diabetes to heal more quickly and effectively. We wanted to know if people treated with NPWT experienced any side effects. We were also interested in the impact of NPWT on people's quality of life.
What were the main results of the review?
In January 2018, we searched for randomised controlled trials that compared NPWT with other treatments for foot ulcers or other open wounds of the foot in people with diabetes. We found 11 trials involving 972 adults. Participant numbers in each trial ranged from 15 to 341 and trial follow-up (observation) times ranged from four weeks to 16 weeks where specified. Not all the studies stated how they were funded. Two were funded by an NPWT manufacturer.
There is low-certainty evidence to suggest that NPWT may be effective in healing postoperative foot wounds and ulcers of the foot in people with diabetes compared with wound dressings, in terms of the proportion of wounds healed and time to healing. For the comparison of different pressures of NPWT for foot ulcers in people with diabetes, we are uncertain whether there is a difference in the number of wounds closed or covered with surgery, and side effects. There was no evidence available on time to closure or coverage surgery, health-related quality of life and cost-effectiveness.
How up to date was this review?
We searched for studies that had been published up to January 2018.
There is low-certainty evidence to suggest that NPWT, when compared with wound dressings, may increase the proportion of wounds healed and reduce the time to healing for postoperative foot wounds and ulcers of the foot in people with DM. For the comparisons of different pressures of NPWT for treating foot ulcers in people with DM, it is uncertain whether there is a difference in the number of wounds closed or covered with surgery, and adverse events. None of the included studies provided evidence on time to closure or coverage surgery, health-related quality of life or cost-effectiveness. The limitations in current RCT evidence suggest that further trials are required to reduce uncertainty around decision-making regarding the use of NPWT to treat foot wounds in people with DM.
Foot wounds in people with diabetes mellitus (DM) are a common and serious global health issue. People with DM are prone to developing foot ulcers and, if these do not heal, they may also undergo foot amputation surgery resulting in postoperative wounds. Negative pressure wound therapy (NPWT) is a technology that is currently used widely in wound care. NPWT involves the application of a wound dressing attached to a vacuum suction machine. A carefully controlled negative pressure (or vacuum) sucks wound and tissue fluid away from the treated area into a canister. A clear and current overview of current evidence is required to facilitate decision-making regarding its use.
To assess the effects of negative pressure wound therapy compared with standard care or other therapies in the treatment of foot wounds in people with DM in any care setting.
In January 2018, for this first update of this review, 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, reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. We identified six additional studies for inclusion in the review.
Published or unpublished randomised controlled trials (RCTs) that evaluated the effects of any brand of NPWT in the treatment of foot wounds in people with DM, irrespective of date or language of publication. Particular effort was made to identify unpublished studies.
Two review authors independently performed study selection, risk of bias assessment and data extraction. Initial disagreements were resolved by discussion, or by including a third review author when necessary. We presented and analysed data separately for foot ulcers and postoperative wounds.
Eleven RCTs (972 participants) met the inclusion criteria. Study sample sizes ranged from 15 to 341 participants. One study had three arms, which were all included in the review. The remaining 10 studies had two arms. Two studies focused on postamputation wounds and all other studies included foot ulcers in people with DM. Ten studies compared NPWT with dressings; and one study compared NPWT delivered at 75 mmHg with NPWT delivered at 125 mmHg. Our primary outcome measures were the number of wounds healed and time to wound healing.
NPWT compared with dressings for postoperative wounds
Two studies (292 participants) compared NPWT with moist wound dressings in postoperative wounds (postamputation wounds). Only one study specified a follow-up time, which was 16 weeks. This study (162 participants) reported an increased number of healed wounds in the NPWT group compared with the dressings group (risk ratio (RR) 1.44, 95% confidence interval (CI) 1.03 to 2.01; low-certainty evidence, downgraded for risk of bias and imprecision). This study also reported that median time to healing was 21 days shorter with NPWT compared with moist dressings (hazard ratio (HR) calculated by review authors 1.91, 95% CI 1.21 to 2.99; low-certainty evidence, downgraded for risk of bias and imprecision). Data from the two studies suggest that it is uncertain whether there is a difference between groups in amputation risk (RR 0.38, 95% CI 0.14 to 1.02; 292 participants; very low-certainty evidence, downgraded once for risk of bias and twice for imprecision).
NPWT compared with dressings for foot ulcers
There were eight studies (640 participants) in this analysis and follow-up times varied between studies. Six studies (513 participants) reported the proportion of wounds healed and data could be pooled for five studies. Pooled data (486 participants) suggest that NPWT may increase the number of healed wounds compared with dressings (RR 1.40, 95% CI 1.14 to 1.72; I² = 0%; low-certainty evidence, downgraded once for risk of bias and once for imprecision). Three studies assessed time to healing, but only one study reported usable data. This study reported that NPWT reduced the time to healing compared with dressings (hazard ratio (HR) calculated by review authors 1.82, 95% CI 1.27 to 2.60; 341 participants; low-certainty evidence, downgraded once for risk of bias and once for imprecision).
Data from three studies (441 participants) suggest that people allocated to NPWT may be at reduced risk of amputation compared with people allocated to dressings (RR 0.33, 95% CI 0.15 to 0.70; I² = 0%; low-certainty evidence; downgraded once for risk of bias and once for imprecision).
Low-pressure compared with high-pressure NPWT for foot ulcers
One study (40 participants) compared NPWT 75 mmHg and NPWT 125 mmHg. Follow-up time was four weeks. There were no data on primary outcomes. There was no clear difference in the number of wounds closed or covered with surgery between groups (RR 0.83, 95% CI 0.47 to 1.47; very low-certainty evidence, downgraded once for risk of bias and twice for serious imprecision) and adverse events (RR 1.50, 95% CI 0.28 to 8.04; very low-certainty evidence, downgraded once for risk of bias and twice for serious imprecision).