1 INTRODUCTION

Over the last few years, with the rise in the incidence of diabetes, the complications associated with diabetes.¹ Diabetic foot ulcers are an increasingly common complication of diabetes, with a high incidence and death rate worldwide.² Diabetes resulting in peripheral neuropathy and vasculopathy, which causes dry and irritated toes and eventually results in sores that will not heal in time.³

Sadly, there has been little effect on the number of amputations related to diabetes in the last few decades.⁴ On the other hand, a few countries, including Belgium, have successfully achieved a reduction in the incidence of diabetes-related adverse events following systematic organizational reforms.⁵

There are several common treatment methods for DM, based on the kind of DM. These include surgical debridement of the wound and systematic use of broad spectrum antibiotics when infection occurs.⁶ In certain cases, however, such conventional approaches do not work and can lead to long recovery, ulcerations and amputations. In the last few years, a variety of therapies have been promoted including advanced wound dressings and other wound treatments.

Along with the development of new therapies, a number of novel therapy methods based on cell histologic and biochemical methods have been developed.⁷ Of all kinds of auxiliary and support methods, such as bioengineered skin transplantation and NPWT, seem especially promising for treating diabetic foot ulcers.⁸ NPWT is a novel and non-invasive adjunct therapy. NPWT is a machine that creates a vacuum in the area of the injury with the external environment, which contributes to the recovery of the wound by removal of liquid from the open wound, preparation of the wound bed for closing, reduction of swelling and promotion of granulating and perfusing.^{9, 10} Although NPWT is generally acknowledged to be efficacious, there are large differences in the reports from the clinical literature and insufficient quantification of the findings.

A number of clinical studies have shown that NPWT is a very efficient and secure way to improve the healing of the leg.^{11, 12} It is also worth noting that NPWT seems to be more costly for treating diabetes foot ulcers compared with conventional approaches. While some prior studies have concentrated on one or more NWPT factors in treating DM, e.g. in terms of effectiveness, safety and cost-effectiveness, it is not always possible to evaluate all these elements at the same time. Thus, there is a pressing need for a standardized meta-analysis that uses the evidence from current studies to evaluate the effectiveness and security of NPWT in treating DM and may offer a comprehensive assessment of the possible benefits of NPWT. The purpose of this meta-analysis is to evaluate the effectiveness and security of NPWT as an adjunct to DFU.

2 METHODS

2.6 Data analysis

All data were evaluated with Revman 5.3 software. First, we conducted a chi-square analysis to see whether there were differences in the results. Values of p > 0.1 and I² < 50% showed that there were no statistically significant differences among trials. Here, we analyse the data with a fixed-effect model. But when p < 0.1, I² > 50%, and no clinically heterogeneous data were found, we selected a random effect model. The mean difference (MD) and 95% CI were computed for the continuum and the ratio ratio (OR), respectively, and 95% CI for the binary variables. A two-sided p-value below 0.05 was taken as an indication of the statistical significance (Figure 1).

3 RESULTS

3.1 Study characteristics

In this paper, 406 related researches were collected from three English databases, and 17 related research were collected under the current exclusion criteria. Of these, 831 cases were treated by NPWT, 834 were treated with standard therapy. The features of the inclusion of DM foot ulcers are presented in Table 2. Quality assessments for contained RCT references are presented in Figures 2 and 3. Quality assessment results for the contained nRCT references are presented in Figures 4 and 5.

TABLE 2. Distribution characteristics of the selected studies.

Study	Year	Style	Country	NPWT	Age	Standard	Age
Anjum13	2022	RCT	Pakistan	20	42.95 ± 9.29	20	46.30 ± 9.33
Armstrong14	2005	RCT	USA	77	57.2 ± 13.4	85	60.1 ± 12.2
Blume15	2008	RCT	USA	169	58 ± 12	169	59 ± 12
Borys16	2018	nRCT	Poland	53	65.4 ± 8.6	22	64.2 ± 6.8
Chiang17	2017	RCT	Australia	12	61.0 ± 12.9	10	62.0 ± 13.9
Ikura18	2014	nRCT	Japan	32	60.0 ± 15.4	48	63.5 ± 13.8
James19	2019	RCT	India	27	55.85 (35–95)	27	52.89 (28–70)
Lone20	2014	RCT	India	28	53.79 ± 5.45	28	54.57 ± 4.78
Malekpour21	2021	RCT	Iran	30	70.31 ± 5.92	30	71.80 ± 6.32
Maranna22	2021	RCT	India	22	50.23 ± 10.52	23	49.00 ± 10.14
Nain23 C	2011	RCT	India	15	61.33 ± 7.63	15	55.40 ± 11.54
Prasad24	2024	RCT	UK	50	62.5 ± 8.3	50	63.8 ± 7.9
Ravari25	2013	RCT	Iran	10	—	13	—
Seidel26	2020	RCT	Germany	171	67.6 ± 12.3	174	68.1 ± 11.5
Shams27	2023	RCT	Pakistan	40	58.13 ± 8.44	40	56.89 ± 7.23
Ulusal28	2011	nRCT	Turkey	15	—	20	—
Vaidhya29	2015	nRCT	India	60	—	60	—

3.2 Wound healing

A total of 14 studies have been conducted to investigate the influence of NPWT and non-NPWT in patients with diabetes mellitus. In these trials, NPWT was shown to speed up wound healing (OR, 2.57; 95% CI, 1.72, 3.85 p < 0.0001), Figure 6. Since there were no notable differences in the two trials (I² = 50%), we conducted a subset of the results by reference type. In 10 RCT trials, NPWT has been shown to speed up wound healing in DM foot ulcers (OR, 2.48; 95% CI, 1.58, 3.89 p < 0.001), Figure 7. NPWT has also been shown to speed up the healing of the wound in patients with DM in the 4 nRCT trials (OR, 2.95; 95% CI, 1.03, 8.42 p = 0.04), Figure 7.

3.3 Amputation

The impact of NPWT and non-NPWT on amputations in diabetic foot ulcers was investigated in 11 studies. The results showed that NPWT was associated with a reduction in amputations (OR, 0.53; 95% CI, 0.37, 0.74 p = 0.0002), Figure 8. The published errors of the 11 trials are presented in Figure 9. Since RCT and nRCT trials were also involved, we analysed the outcomes by group by literature category. In nine RCT trials, NPWT showed a reduction in amputations (OR, 0.61; 95% CI, 0.43, 0.87 p = 0.007), Figure 10. In both nRCT trials, NPWT also showed a reduction in amputations (OR, 0.03; 95% CI, 0.00, 0.24 p = 0.001), Figure 10.

4 DISCUSSION

The abnormal cellular proliferation, vascular dysfunction, micro-environment, inflammation and so on are the major causes of DF incorrection.³⁰ Vacuum Injury Treatment is a technique that utilizes various types of internal and external forces to remove dead tissue and excretions from the wound, thereby decreasing the rate of infection and maintaining moisture in the wound.³¹ Nevertheless, the results of the study were inconsistent, the data were mixed and the combined effect was not strong. The meta-analyses of prior researchers contained 11 randomized controlled studies, however most of these studies were pre-2010, and the majority did not describe randomization techniques or treatments.³² There are 17 related trials in this trial, with 13 RCTs and four nRCTs. The number of trials before 2010 was 2 for all the trials. This is a good way to make up for the absence of prior research.

Conventional wound management employs a variety of different types of bandages to facilitate the healing of the wound, but the bandages often stick to the scar.³³ The NPWT technique has been shown to be effective in improving the micro-environmental condition of the injury, altering the haemodynamics of micro-vasculature and controlling the infection of the wound.³⁴ The most frequent side effects during therapy are swelling of the wound, bleeding, pain and infection. Adequate adjustment of negative pressure has been demonstrated in order to prevent a propensity for bleeding and complete closure of the cut.³⁵ To prevent amputations in the past, appropriate assessment of a prior history of DM, optimization of serum sugar levels to facilitate wound healing, and the provision of multidisciplinary treatment can be helpful in order to prevent amputations.³⁶

In the current analysis of the findings, there are more than 10 test participants. We also conducted a subset of the findings. Finally, the final subgroup analysis was in agreement with the general findings. There are, however, certain limitations of this research.

Significant data from the data from the included trials are not entirely available. Currently, there is no stratification or randomization of the severity of DFU; thus, there is an imbalance between the two groups. Clinical diversity was also observed as a result of a small sample size, inadequate presentation of methodology details and inadequate follow-up time. Our reports might have been skewed by nonrandomized factors that influenced the assignment of a particular therapy. From the information we have gathered, it is clear that those with more serious injuries, especially those with bigger sores, are more likely to be classified as NPWT. Poor regression in DM with both conventional NPWT treatment and other trial methods might be associated with a preference for those with especially clinical problems. Furthermore, there were only a few trials in the comparator group, with the majority being performed on NPWT-treated patients. It is also important to point out that the lack of comparison data in meta-analyses does not allow for a robust evaluation of published bias. Lastly, it is possible that the documentation is not complete as we have only looked at the published papers. Thus, we need to be cautious in our meta-analyses.

5 CONCLUSION

Applying NPWT to patients with DFU will improve the healing of the wound and lower the risk of amputations. Similar results were observed in the RCT and non-RCT trials in the subgroup analysis. NPWT can be used to treat diabetes foot ulcers caused by diabetes.

CONFLICT OF INTEREST STATEMENT

The authors declare no conflict of interest.