European Journal of Cardiovascular Medicine

Hyperglycemia without medication is a hallmark of a group of metabolic illnesses that are collectively referred to as diabetes mellitus, or just diabetes. Its diverse etiological background includes potential abnormalities in insulin action, secretion, or both.¹

An estimated 422 million people worldwide suffer from diabetes, most of whom reside in low- and middle-income nations. The disease is directly responsible for 1.5 million fatalities annually..²

According to research done by the Indian Council of Medical Research (ICMR), 11.4% of Indian adults are projected to have diabetes. This means that a startlingly large number of people—possibly as many as 101 million people nationwide—live with this metabolic condition.³

The long-term complications of diabetes include nephropathy, retinopathy, and neuropathy. Furthermore, diabetes is a significant risk factor for stroke, heart attacks, kidney failure, blindness, and amputation of a lower limb.^1,4

Diabetic foot ulceration (DFU) represents a devastating complication associated with diabetes mellitus (DM).  Characterized by the breakdown of skin and underlying tissues in the foot, DFU presents a significant threat to patients' well-being.  This complication not only increases the risk of infection but also poses a serious threat of limb amputation, potentially leading to even mortality.  Furthermore, the prevalence of DFU appears to be on the rise among individuals with diabetes, necessitating a heightened focus on preventive and management strategies.⁵Diabetic foot ulcer (DFU) development is a complex interplay of factors, stemming from the underlying diabetic pathophysiology and its associated complications. These factors can progressively lead to varying degrees of neurological and vascular damage in the lower extremities. The concerning prevalence of DFU, coupled with its inherent treatment challenges, translates to a significant financial burden on healthcare systems. This burden arises from production losses due to patient morbidity and the high costs associated with managing chronic wounds.⁶

Effective management of Diabetic Foot Ulcers (DFUs) necessitates a multifaceted approach encompassing pressure relief, debridement or de-sloughing of necrotic tissue, meticulous infection control measures, and appropriate wound dressing selection. Wound dressings play a pivotal role in DFU care, serving the dual purpose of protecting the exposed tissues and promoting optimal healing.⁷

Sucralfate serves as a cytoprotective medication that is predominantly used to treat ulcers of the gastrointestinal tract, such as duodenal, gastric, and gastritis ulcers. Recent studies suggest sucralfate can be implemented topically to open wounds and has positive effects for treating persistent ulcers.⁸

This investigation aims to evaluate the comparative efficacy of topical sucralfate versus normal saline dressing in promoting wound healing among patients with diabetic foot ulcers.

Materials and method

A prospective hospital-based study was carried out among in-patients of both genders who were admitted to the Department of General Surgery of a tertiary care hospital in Puducherry due to diabetic foot ulcers over six months, from July 2023 to December 2023, sixty participants participated in the trial. Informed consent was taken from the participants prior to inclusion in the study

Inclusion criteria

Diabetic patients under regular treatment, between the age group of 18 -75 years with diabetic foot ulcer (Grade-2, according to Wagner Classification)⁹ for more than 2 weeks, and giving consent for topical sucralfate application.

Exclusion criteria

Patients with a history of Coronary artery disease, Cerebrovascular accidents, peripheral artery disease, associated septicemia, and osteomyelitis skin malignancies, exposed bones, and Charcot's joint were excluded from the study. 

Group Allotment and Procedure

Patients fulfilling the selection criteria were randomly allocated into two equal groups. Dressing in group-1 wasdone with topical application of sucralfate along with the conventional method, whereas in group-2, only conventional dressing with normal saline was done. Both groups were subjected to dressings on alternate days. Debridement was done when needed and appropriate wound care was given in both groups.

An assessment of wound condition was undertaken upon admission, followed by evaluations at the fourth- and eighth-weeks post-admission for both groups. This evaluation included measurements of wound size, the presence of slough (dead tissue), and the development of granulation tissue (vascular tissue promoting wound healing).

Statistical analysis

The data was entered in Microsoft Excel and analyzed using Jamovi v 2.3.28. For categorical variables, the data were shown as frequencies and proportions, and for continuous variables, as mean (SD). The two groups' treatment modalities were compared for efficacy using the Mann-Whitney U Test and Chi-square test. It was established that a probability value (p-value) of less than 0.05 was statistically significant.

Among the study population, 45% (n=27) and 55% (n=33) were male and female respectively. The overall mean age of the study population was found to be 58 (7.34) years and the distribution among the two groups was years 59.3 (7.76) and56.7 (6.74) years respectively.

More than half of the patients in the study (n=32, 53%) were under insulin administration for diabetic management, else were using oral hypoglycaemic drugs. The mean (SD) HbA1C of the study population was found to be 8 (1.09). Table 1 depicts the distribution of HbA1C levels among the study population. The mean (SD) of HbA1C among Group A and Group Bwas7. 96 (0.96) and 8.03 (1.2) respectively. There is no significant difference between HbA1C levels among the two groups (p-value =0.805).

Table 1: HbA1C levels among the study population

Table 2 shows the prevalence of wound stage among the sucralfate and normal saline groups. There is no significant difference between the two groups whenaboutthe distribution of wound stage (p-value = 0.965).

Table 2 Prevalence of wound stage among the Sucralfate and normal saline

From Table 3,it is evident that there is no significant difference in wound size between the two groups on admission, but wound size was reduced in group A inthe 4^th and 8^th week of admission which is statistically significant with a p-value of 0.001. Figure 1 depicts the rate of reduction in wound size between the two groups across the course of treatment.

Table 3 Wound size among the study population

Figure 1 Wound size between the two groups across the course of treatment

Through Table 4, it is evident that there is a significant difference in the formation of granulation tissue between the two groups at 4^th and 8^th week of admission.There is no significant difference in the presence of granulation tissue at the time of admission, but healthy granulation tissue was noted in seventy percent of the patients in group A, whereas only fifty-five percent in group B.

Table 4Growth of granulation tissue among the two groups

Through Table 5 it is observed that the occurrence of the slough was reduced in group A at the 4^th and 8^th week of admission, with p-values of 0.038 and 0.037 respectively, which were statistically significant.

Table 5Occurrence of slough among the two groups

Diabetes ulcers are among the surgical aftereffects that occur most frequently. These ulcers have been treated in the past using a wide variety of techniques. The idea that ulcers should be kept dry is rapidly fading. Several novel dressings have been created in the previous 25 years. Sucralfate therapy is the most efficient way to hasten the healing of diabetic ulcers. Preclinical studies have demonstrated that sucralfate increases granulation tissue synthesis, which helps cutaneous ulcers heal.¹⁰

From the study, it has been evident that dressing with topical application of sucralfate had led to a significant reduction in wound size in comparison with the conventional method of dressing with normal saline, which can be supported by the similar findings of Shivram S (2017),¹¹where it was discovered that, in comparison to conventional betadine dressings, the use of topical sucralfate in the treatment of diabetic foot ulcers produced a greater percentage reduction in wound size and early wound healing with improved efficacy.

The disaccharide sucrose octa sulfate is soluble in aluminum hydroxide, which is known as sucralfate. It has demonstrated potential usefulness in the healing of skin wounds and is taken orally to treat gastrointestinal ulcers. Sucralfate aids in the production of growth factors, particularly fibroblast growth factor (FGF), which is crucial for angiogenesis and the proliferation of keratinocytes and dermal fibroblasts. Additionally, it stimulates the production of granulation tissue, raises the release of interleukin-1 (IL-1) and interleukin-6 (IL-6), and eventually aids in the healing of ulcers.¹²

Also, the proliferation of granulation tissue was more among the patients managed with the topical application of sucralfate when compared to normal saline dressing, which is similar to the findings reported byYuniati R et al (2021)¹⁰, where they demonstrated the combination of sucralfate and therapy is the most effective modality to accelerate wound healing in diabetic ulcers after 14 days of treatment compared to the other treatment groups.

Sucralfate exerts its anti-ulcerogenic effects through a multifaceted mechanism.  One key aspect involves its ability to inhibit pepsin A activity, thereby protecting the mucosal barrier from enzymatic degradation.  Furthermore, sucralfate demonstrates binding affinity for epidermal growth factor (EGF) and tissue growth factors, facilitating their interaction with ulcerated tissues. This promotes cellular proliferation and repair processes, ultimately contributing to ulcer healing.¹³

In addition to this, there has been a significant reduction in slough production from the ulcer in patients managed with sucralfate, which is similar to the findings of Ganankkumar T (2021)¹⁴, where they demonstrated that participants receiving sucralfate dressing had a better area of reduction of 43.78% compared to the control group receiving only conventional dressing (normal saline dressing), where the mean area of reduction was 28.72% (P < 0.0001). According to these outcomes, sucralfate dressing can be a beneficial tool for helping diabetic foot ulcer patients reduce the area of their wounds. It can also be added to conventional treatment to promote quicker and more effective healing.

This study has demonstrated the effectiveness of sucralfate in minimizing wound dimensions as well as encouraging complete wound healing of ulcers. Whether it comes to diabetic foot ulcers, it proven to be more effective, safe, and facilitates wound healing than conventional dressings. In consequence, it can be suggested as a different approach to treating diabetic ulcers.

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