Diabetes mellitus has emerged as a major multisystemic disease of the modern era, with India rapidly becoming the global capital of the condition. According to the ICMR-INDIAB-17[1] national cross-sectional study estimates, the prevalence of diabetes and prediabetes in India is 101 million and 136 million, respectively, numbers that are much higher than earlier estimates in 2019 (77 million). Approximately 57% of these individuals remain undiagnosed. The situation becomes even more alarming considering a more recent report from the NCD Risk Factor Collaboration (NCD-RisC) survey[2], which reported the number of people with diabetes in India to be 212 million. Uncontrolled diabetes leads to an increased risk of vascular disease; indeed, much of the burden of type 2 diabetes is caused by macrovascular complications (cardiovascular, cerebrovascular, and peripheral artery diseases) and microvascular complications (retinopathy, nephropathy, and neuropathy). These diabetic complications are a significant cause of increased premature morbidity and mortality among individuals with diabetes, leading to reduced life expectancy and profound economic strains on the Indian healthcare system. The burden of diabetic complications in India remains exceptionally high, driven primarily by the country's vast diabetic population. Existing literature from India reports a broad prevalence range of 5% to 37% for macrovascular and microvascular complications among patients with diabetes. Furthermore, a large-scale multicentric screening study conducted across India revealed that 8.7% of the evaluated diabetic population suffered from active foot ulcers and blisters.[3] Among these microvascular complications, diabetic foot ulcers (DFUs) present a significant clinical challenge due to their prolonged and complex healing trajectories. The chronicity of these ulcers contributes significantly to pain, patient suffering, and physical disability. Furthermore, it frequently leads to diabetic foot osteomyelitis and remains one of the leading causes of non-traumatic lower-limb amputation.[4]  Wound healing in diabetic foot ulcers depends on numerous systemic and local factors; healing is typically prolonged, and primary closure is often clinically unachievable. Chronic DFUs impose immense psychological and financial burdens on patients, frequently requiring extended hospitalization. Many cases necessitate advanced surgical interventions, including repeated wound debridements, split-skin grafting (SSG), or local skin flaps. In severe instances, lower-extremity amputations are required, drastically restricting mobility and increasing patient morbidity and mortality. Importantly, diabetic foot syndrome remains the most common yet preventable complication of diabetes. In India, this high burden is deeply intertwined with sociocultural and economic factors, such as a widespread lack of awareness, inadequate diabetic care facilities, poverty, and challenging socioeconomic conditions. Despite the prevalence of DFUs, the optimal topical therapy remains ill-defined. While saline-moistened gauze has traditionally served as the standard care method, it fails to maintain a continuously moist wound environment essential for healing. Furthermore, DFUs are frequently complicated by low- to high-grade polybacterial infections, which are exceptionally difficult to treat with targeted antibiotic regimens due to the compromised immunity inherent in diabetic patients.

Currently, povidone-iodine (Betadine) remains the dominant topical intervention for diabetic foot ulcers across the Indian subcontinent. This persistent clinical reliance is driven by a unique intersection of epidemiological challenges and socioeconomic realities. Clinically, DFUs in Indian patients are frequently complicated by high-grade, polybacterial infections. Povidone-iodine addresses this by providing immediate, broad-spectrum bactericidal activity against both Gram-positive and Gram-negative pathogens without inducing bacterial resistance. The mechanism of action involves the slow release of free iodine from the povidone-iodine complex, which exerts its antimicrobial effect through the oxidation of essential proteins and nucleic acids in microbial cells.[5] From a public health perspective, the unmatched cost-effectiveness and ubiquitous supply chain availability of povidone-iodine make it a highly practical option. It remains readily accessible at all levels of healthcare, from rural primary health centres to crowded tertiary facilities. While povidone-iodine has proven efficacy in reducing bacterial load and preventing infection, concerns have been raised regarding its potential cytotoxic effects on host cells, particularly fibroblasts and keratinocytes, which are essential for wound healing.[5] While contemporary guidelines often caution against the routine use of traditional antiseptics due to this potential cellular cytotoxicity on regenerating tissue, the logistical simplicity and financial accessibility of povidone-iodine ensure its continued role as the baseline standard of care in resource-limited settings. Consequently, various therapeutic agents are continuously investigated to accelerate wound healing and promote the formation of healthy granulation tissue. One such promising agent is phenytoin. Topical phenytoin sodium possesses robust wound-healing properties driven by several distinct physiological mechanisms. These include increased fibroblast proliferation, inhibition of collagenase activity, promotion of collagen deposition, enhanced granulation tissue formation, decreased bacterial contamination, reduced wound exudation, and the upregulation of growth factor receptors.[4] Additionally, the antibacterial activity of phenytoin contributes to the removal of pathogens such as Staphylococcus aureus, Escherichia coli, Klebsiella species, and Pseudomonas. Validating these mechanisms, DaCosta et al. [6] concluded that phenytoin alters the natural trajectory of wound healing. Their findings suggest a clear clinical benefit in scenarios where defective collagen deposition typically compromises wound integrity, leading to elevated morbidity and mortality. Notably, wounds treated with phenytoin exhibited marked fibroblast proliferation and neovascularization compared to controls within 3 days. By day 6, although the local inflammatory infiltrate had almost completely subsided, fibroblast infiltration and angiogenesis remained persistently pronounced. Similarly, Tauro et al. [7] evaluated the clinical efficacy of this treatment in a study involving 200 patients with diabetic ulcers and concluded that topical phenytoin significantly accelerates the healing of diabetic wounds and improves subsequent skin graft take-up.

Despite advancements in wound care, establishing an optimal topical therapeutic regimen for diabetic foot ulcers (DFUs) remains a significant clinical challenge. While povidone-iodine (Betadine) remains a cornerstone of current wound care practices primarily due to its broad-spectrum antimicrobial properties, it does not actively stimulate tissue repair. In contrast, emerging biomedical evidence indicates that topical phenytoin sodium offers a multi-targeted therapeutic approach. Beyond exhibiting antimicrobial activity, phenytoin directly addresses the underlying pathophysiological deficits of diabetic wounds by actively stimulating fibroblast proliferation, accelerating neovascularization, and regulating local inflammation. Investigating a cost-effective, multi-mechanism agent like phenytoin is highly clinically relevant, particularly given the severe morbidity, high amputation rates, and immense socioeconomic burdens associated with chronic diabetic complications. Because there is a critical shortage of robust, comparative clinical data directly evaluating the efficacy of tissue-regenerating agents against standard antiseptic dressings, this comparative study was designed to bridge this gap by evaluating the clinical outcomes of topical phenytoin against 10% povidone-iodine dressings. This trial aims to establish a more effective, accessible, and economically viable evidence-based protocol to improve patient outcomes and alleviate healthcare resource strains in managing diabetic foot syndrome.

2.1 SOURCE OF DATA The study was conducted on 50 patients with clinically confirmed cases of Diabetic foot ulcer in General Hospital, Gundlupete, Chamarajanagar. 2.2 INCLUSION CRITERIA 1. Age: Above 18 years of either sex with clinically diagnosed cases of diabetic foot ulcer 2. Grade 1 and 2 foot ulcers according to Meggit-Wagner clinical classification 3. Presence of diabetic foot ulcers with controlled glycemic status by oral hypoglycaemic agents or insulin (FBS <120 mg/dl, HbA1c <8%) 4. Ulcer size measuring up to 10 cm in largest diameter 5. Patients who give consent to participate in study. 2.3 EXCLUSION CRITERIA 1. Diabetic foot ulcers of Wagner classification grades 3, 4, and 5 2. Chronic ulcer of other etiology including arterial insufficiency, venous disease, pressure sores, or malignancy 3. Other co-morbid conditions like renal failure, generalized debility, immunosuppression, or malnutrition, which adversely affect wound healing 4. Known hypersensitivity or allergy to phenytoin or betadine solution or iodine based preparations 5. Active severe skin or soft tissue infection requiring systemic IV antibiotics. 6. Patients with any bleeding disorder or on anti-coagulant drugs 7. Previous local surgery 2.4 AIM AND OBJECTIVES The primary objective of this clinical investigation was to evaluate and compare the therapeutic efficacy of a 50 mg/mL topical phenytoin formulation against a 10% povidone-iodine (Betadine) solution as dressing agents for diabetic foot ulcers (DFUs). Specifically, this study sought to determine which topical modality accelerates wound healing more effectively, measured by the onset and duration of granulation tissue formation alongside the rate of re-epithelialization. Secondary endpoints focused on assessing the comparative inhibition of bacterial growth within the ulcer bed, monitoring patient compliance, and evaluating overall tolerance to each treatment regimen. Furthermore, the trial documented any treatment-associated adverse profiles or clinical complications. A secondary analysis aimed to identify patient-specific variables influencing therapeutic response, with the ultimate goal of establishing evidence-based protocols for optimal topical agent selection in the clinical management of diabetic foot syndrome. 2.5 STUDY DESIGN AND STUDY POPULATION This clinical trial was designed as a prospective, randomized, single-blind, controlled study conducted at the General Taluk Hospital in Gundlupete. Following the acquisition of written informed consent, a total of 50 patients with clinically and radiologically confirmed diabetic foot ulcers (DFUs) were enrolled. The study cohort was randomized and allocated equally into two distinct parallel treatment groups, with 25 participants assigned to each arm. At baseline, a comprehensive medical history was elicited from each participant. This was followed by a rigorous clinical evaluation to assess overall systemic health, localized wound characteristics, peripheral vascular status, and the extent of peripheral neuropathic changes across the lower extremities. 2.6 PROCEDURE AND STUDY GROUPS Upon enrollment, each patient underwent standardized wound bed preparation consisting of thorough surgical debridement to remove necrotic tissue and slough, followed by wound cleansing using sterile normal saline. Following complete slough removal, the total surface area of the ulcer was quantified using a dual-step tracing method. The wound outline was first meticulously traced onto sterile butter paper and subsequently transferred onto a metric graph paper grid. To ensure precision and minimize inter-observer variability, ulcer surface area measurements were performed twice on each occasion. When the two measurements were identical, that specific value was documented. In instances of discrepancy, the mean of the two values was calculated and recorded. The definitive wound surface area was computed in square centimeters (cm2) using the Flanagan method, which involves multiplying the maximum perpendicular length by the maximum width of the wound bed as verified by a calibrated ruler over the graph paper tracing. STUDY GROUP I (Dressing with phenytoin) Participants allocated to the group underwent topical wound dressing using a prepared phenytoin sodium suspension. To achieve a standardized concentration of 50 mg/mL, a 200 mg phenytoin sodium capsule was aseptically opened, and its contents were thoroughly suspended in 4 mL of sterile normal saline. Sterile gauze was then completely saturated with this freshly prepared suspension. The medicated gauze was meticulously applied over the wound bed to deliver an approximate target dose of 25 mg of phenytoin sodium per square centimeter (cm2) of the calculated ulcer surface area. STUDY GROUP II (Convention dressing with povidine iodine 10% w/v solution) Participants allocated to the control group received conventional wound care utilizing a standard 10% w/v povidone-iodine solution. Under strict aseptic conditions, sterile gauze was completely saturated with the povidone-iodine solution. The medicated gauze dressing was then meticulously applied over the prepared wound bed, ensuring uniform coverage across the entire surface area of the ulcer. 2.7 POST PROCEDURE PERIOD AND FOLLOW UP Wound dressings were performed on a daily basis for participants in both the topical phenytoin and conventional povidone-iodine treatment arms. The primary outcome measures evaluated in this study included the overall time to complete wound healing, the percentage of granulation tissue formation recorded at weekly intervals, the rate of re-epithelialization, and the total reduction in ulcer surface area. Participants were monitored on a daily basis during the first week of intervention, followed by evaluations thrice weekly for a maximum study duration of 8 weeks. At each clinical visit, a comprehensive wound assessment was executed, comprising precise measurement of wound dimensions, standardized photographic documentation, visual estimation of granulation tissue percentage, and the tracking of local clinical symptoms. Additionally, patient-reported pain scores were monitored using a validated Visual Analogue Scale (VAS). Furthermore, the wound bed was evaluated for the presence of slough, necrotic tissue, and overt signs of secondary infection. To evaluate dynamic shifts in microflora and bacterial load, qualitative and quantitative wound cultures were collected at baseline and on day 10. Throughout the study period, patients were closely monitored for treatment compliance rates, any spontaneously reported local or systemic adverse effects, which were systematically documented. 2.8 STATISTICAL METHODS: The data in this study underwent both descriptive and inferential statistical analyses. Continuous variables are expressed as mean ± standard deviation (minimum–maximum), whereas categorical variables are reported as frequencies and percentages [Number (%)]. Statistical significance was evaluated using a threshold of 5% (alpha = 0.05). Continuous variables were compared using Student's t-test after assessing normality with Shapiro-Wilk test. Categorical variables were comparisons made using chi-square test or Fisher's exact test as appropriate. Time-to-event analysis was performed using Kaplan-Meier survival curves with log-rank test for comparison Statistical software: The Statistical software namely SAS 9.2, SPSS 16.0, socscistatistics calculators, and MedCalc 9.0.1 were used for the analysis of the data and Microsoft word and Excel have been used to generate tables

Table1: Age distribution of patients studied

Samples are age matched with Student t test. The result is not significant at p <.05. Mean age of this study is 52.36 ± 6.52 (24–66 years)

Table 2: Demographic and Baseline Characteristics of the Study Cohort

Table 3: Occupation distribution in two groups of the study cohort

Table 4: Primary Outcome: Comparison of Ulcer Surface Area Reduction over Time.

Table 5: Primary Healing Outcome: Comparison of healing over Time.

Table 6: Summary of Secondary Endpoints: A Comparative Analysis of Phenytoin and Povidine iodine Dressing Cohorts

A cohort of 50 patients presenting with diabetic foot ulcers (DFUs) met the predefined inclusion criteria and was successfully enrolled in this clinical investigation. The study population exhibited a male predominance, comprising 37 males (74.0%) and 13 females (26.0%). Across the entire cohort, the collective mean age was 52.36 ± 6.52 years, spanning a range of 24 to 66 years, while the mean duration of diagnosed diabetes mellitus was 8.1 ± 5.47 years. Regarding occupational demographics, agricultural workers constituted the largest subgroup, accounting for 48.0% of the sample population (n = 24/50). Following formal randomization, baseline demographic variables and clinical characteristics remained well-balanced and highly comparable between Group I and Group II. Statistical analysis confirmed that there were no significant confounding differences between the two therapeutic arms (p > 0.1). In the present study, the mean age of the participants was 53.56 ± 7.52 years in the topical phenytoin cohort and 51.43 ± 6.29 years in the conventional povidone-iodine group, yielding a collective cohort mean age of 52.36 ± 6.52 years. These demographic findings align closely with data reported in similar clinical trials conducted by Rituraj et al.[8] and Jayalal et al.[9] Specifically, Rituraj et al. documented a mean age of 55.71 ± 11.5 years in their phenytoin-treated group and 54.31 ± 12.24 years in their conventional dressing group. Similarly, Jayalal et al. noted a mean age of 52.63 ± 7.1 years and 53.1 ± 6.8 years in the phenytoin and conventional dressing arms, respectively. This demographic consistency across studies highlights the representative nature of the current study cohort regarding age distribution in chronic diabetic ulcer populations. The highest concentration of diabetic foot ulcer cases in this study occurred within the 41–50 and 51–60 years age intervals, which accounted for 34% and 32% of the cohort, respectively, and together constituted a combined 66% of the total study population. These findings correspond well with existing literature evaluating age distributions in diabetic populations. Specifically, Vardhan et al.[10] documented that the 51–60 years age group was the most heavily affected, comprising 50% of their study participants. Similarly, Yadwadkar et al.[11] reported that the highest incidence of cases fell within the same 51–60 years age bracket, representing 44% of their total cohort. While the peak age demographic in the current study spans a slightly younger range than those reported in these previous trials, the overall trend confirms that chronic ulcerations predominantly impact individuals in their fifth and sixth decades of life. Regarding gender distribution, the study population demonstrated a distinct male predominance, with males accounting for 74% of the participants and females representing 26%. This male-biased demographic trend is consistent with previous literature. For instance, Tauro et al.[7] reported a similar distribution, with males constituting 66% of their cases and females accounting for 34%. Furthermore, Kumar et al.[12] observed that 63% of their cohort were male, while 37% were female. Collectively, these data confirm that diabetic foot ulcerations occur with a significantly higher frequency in male patients than in female patients within the studied regions. The therapeutic efficacy of the interventions and the subsequent quality of the wound bed were evaluated based on the mean percentage of ulcer surface area covered by granulation tissue on the 14th post-treatment day (week 2). In this study, the mean percentage of granulation tissue at this 14-day milestone was 76.24 ± 6.33% in the topical phenytoin cohort, compared to 44.93 ± 10.48% in the conventional povidone-iodine group. This pronounced trend toward accelerated tissue maturation is corroborated by existing clinical trials. Rituraj et al.[8] evaluated this identical parameter on day 14 and reported granulation coverage of 88.21 ± 6.98% in their phenytoin arm and 71.32 ± 7.9% in their conventional dressing arm. Similarly, Tauro et al.[7] noted a mean granulation coverage of 87.94 ± 7.33% in the phenytoin group versus 74.64 ± 8.04% in the conventional cohort. While the absolute percentages achieved in the current trial were slightly lower than those documented in the reference literature, the overall findings consistently demonstrate that topical phenytoin induces significantly superior and more rapid granulation tissue formation than conventional antiseptic care. The reduction in ulcer surface area was statistically significant in the topical phenytoin cohort compared to the povidone-iodine (Betadine) control arm. Although the absolute velocity of wound contraction observed in our phenytoin group was less rapid than the rates reported in alternative literature, the contraction rate remained significantly superior to that of the conventional group. This accelerated reduction in ulcer dimensions, combined with earlier granulation tissue formation, strongly suggests a multi-targeted therapeutic benefit that encompasses enhanced fibroblast activity, accelerated collagen synthesis, and a reduced local infectious burden. Microbiological analysis revealed that Staphylococcus aureus was the most prevalent pathogen isolated from the ulcer beds, accounting for 56% of the total microbial isolates across both treatment cohorts. This high prevalence of S. aureus is well-supported by existing epidemiological data on diabetic foot infections. Kodela et al.[13] similarly identified Staphylococcus aureus as the most common microorganism, isolating it from 45% of their total sample. In addition, Jayalal et al.[9] documented that Staphylococcus aureus was the predominant organism present, accounting for 48.33% of their overall cases. These parallel findings reinforce the understanding of S. aureus as a primary pathogen driving chronic wound contamination and underscore the clinical relevance of selecting topical agents with robust anti-staphylococcal activity. Furthermore, the significantly higher rate of culture conversion achieved by day 10 reinforces the antimicrobial potential of topical phenytoin. This microbiological clearance is likely driven by a combination of direct antibacterial action and upgraded local immune function within the wound microenvironment. These findings align closely with previous clinical trials conducted by Muthukumaraswamy et al.[14] and Tauro et al.[7], further validating the definitive role of phenytoin in accelerating chronic wound repair. Regarding patient-reported outcomes, pain scores on the Visual Analogue Scale (VAS) were markedly better in the phenytoin cohort, a benefit potentially mediated by enhanced tissue regeneration and a lowered rate of secondary infection. Finally, patient compliance remained excellent across both treatment arms, demonstrating highly comparable tolerability profiles between the two topical modalities. Complications: Regarding the safety profile, the localized adverse effects documented during the follow-up period across both cohorts included residual infections (n = 2 in the phenytoin group; n = 1 in the povidone-iodine group), localized hyperpigmentation (n = 1 in each group), contracture formation (n = 1 in the phenytoin group), and localized pain. In the present study, the incidence of these parameters in the topical phenytoin cohort was highly comparable to that observed in the conventional dressing group. This outcome contrasts with the findings reported by Selvaraj et al.[15] and Azeez et al.[16], both of whom observed that complication rates were markedly lower in their phenytoin-treated study groups than in their respective conventional antiseptic control arms, noting an average reduction of approximately 10% in the phenytoin cohorts. Unlike those trials, our results demonstrated a small, statistically non-significant increase in specific complications within the phenytoin branch, though the overall safety profiles remained closely matched between the two groups. Strength and Limitation: The principal strengths of this study include its prospective, randomized design and the rigorous standardization of both interventions, which established a reliable, reproducible framework for comparative analysis. However, several limitations must be acknowledged. First, the total sample size of 50 patients represents a relatively small cohort for evaluating therapeutic modalities in diabetic foot ulcers (DFUs), which are among the most prevalent and pathologically complex complications of uncontrolled diabetes mellitus. This small sample size also limits the ability to control for the wide array of concurrent systemic treatments these patients often receive. Nevertheless, these findings provide critical baseline data that can inform and strengthen future large-scale, multi-center clinical trials. Second, while the results demonstrate clear clinical and functional efficacy, a more comprehensive health economics evaluation is required. The absolute cost-effectiveness and systemic benefits of topical phenytoin need to be systematically weighed against individual monotherapies using multi-level cost-benefit analyses in larger populations.

This comparative study demonstrates that topical phenytoin sodium powder represents a clinically superior, safe, and effective intervention for the management of chronic diabetic foot ulcers. By directly addressing the underlying pathophysiological deficits of diabetic wounds, topical phenytoin significantly accelerates tissue regeneration. This therapeutic efficacy is explicitly confirmed by the accelerated formation of healthy granulation tissue, expedited re-epithelialization, and faster overall wound closure, which ultimately facilitates superior skin graft take-up compared to conventional povidone-iodine protocols. Furthermore, the dual benefit of robust microbial clearance and lowered local infection rates underpins the therapeutic value of this modality, helping to mitigate prolonged inflammatory barriers to healing. From a healthcare delivery perspective, the clinical benefits of topical phenytoin translate directly into reduced durations of hospitalization, thereby mitigating the immense psychological distress routinely experienced by patients suffering from chronic ulcerations. As a universally accessible and logistically simple alternative to both traditional antiseptics and newer, complex topical therapies, phenytoin offers a highly practical solution tailored for resource-limited clinical settings. Integrating topical phenytoin sodium into standard diabetic wound care protocols holds substantial promise for optimizing recovery rates, decreasing long-term complications, and serving as a vital supportive strategy in alignment with the global "Save the Limb, Save the Life" mission to reduce lower-extremity amputations.

DECLARATIONS

Funding: None

Conflict of interest: None declared

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