European Journal of Cardiovascular Medicine

Diabetes has become increasingly widespread globally in recent decades. Around 422 million individuals worldwide have diabetes, and the majority are residing in poor and developing countries. Each year, around 1.5 million population are directly linked to diabetes. The number of diabetes cases and its prevalence have both been on the rise over the years. In India, an estimated 77 million people over 18 years of age suffer from type 2 diabetes, while nearly 25 million are at high risk of developing diabetes in the future.1 Diabetes is linked to various complications affecting microvascular, macrovascular, and metabolic aspects. These complications include cerebrovascular, cardiovascular, and peripheral arterial disease2; retinopathy3; neuropathy; and nephropathy.4 the foot ulcers are a common complication among uncontrolled diabetics.5 this can lead to osteomyelitis6 and eventually result in the amputation of the limb.

Between 1958 and 1993, the number of diagnosed diabetes cases increased fivefold. In 1980, the diabetic population was 108 million. It increased to 422 million in 2014. The prevalence is growing faster in poor and developing countries compared to high-income countries. Currently, 8.5% of adults aged 18 years and above have diabetes. In 2019 alone, diabetes caused approximately 1.5 million deaths, with almost half occurring before the age of 70 years. Diabetes significantly contributes to blindness, kidney failure, heart attacks, strokes, and lower limb amputations.7

From 2000 to 2019, there was a notable increase in age-adjusted mortality rates due to diabetes worldwide, particularly in poor and developing countries, which saw a 13% rise in mortality rates related to diabetes. The overall risk of developing a foot ulcer is between 19% and 34%, with a risk of frequent recurrence following initial healing. About 40% within one year after healing, nearly six out of ten within three years, and around two-thirds within five years reported recurrence. Notably, when it comes to lower extremity amputations among diabetics, a significant majority (85%) are preceded by a diabetic foot ulcer.7

Thus, diabetic foot ulcer management, along with control of blood sugar levels, plays an important part in minimizing amputation rates. For effective management of these ulcers, we need scoring systems that are simple yet effective in predicting the serious outcomes. Many wound-based classifications of diabetic foot ulcers are proposed, and one such simple wound-based scoring system is the Diabetic Ulcer Severity Score (DUSS) by Beckert et al8, which has to be validated clinically.

Aim: To assess the clinical validation of diabetic ulcer severity score (DUSS) in predicting the outcome of diabetic foot ulcers. Objectives: To calculate the Diabetic Ulcer Severity Score (DUSS) and to validate the score to predict the outcomes ranging from healing of the ulcers to amputations.

TABLE 1: AGE WISE DISTRIBUTION IN THE STUDY

TABLE 2: PATIENTS CHARACTERISTICS IN THE STUDY

TABLE 3: DUSS SCORE DISTRIBUTION AMONG THE STUDY PARTICIPANTS

TABLE 4: DURATION TO ATTAIN THE OUTCOME

TABLE 5: DISTRIBUTION OF STUDY PARTICIPANTS BASED ON PATIENT OUTCOME

TABLE 6: PATTERN OF ULCER HEALING WITH DUSS SCORE 0 IN FOLLOW-UP VISITS

TABLE 7: PATTERN OF ULCER HEALING WITH DUSS SCORE 1 IN FOLLOW-UP VISITS

TABLE 8: PATTERN OF ULCER HEALING WITH DUSS SCORE 2 IN FOLLOW-UP VISITS

TABLE 9: PATTERN OF ULCER HEALING WITH DUSS SCORE 3 IN FOLLOW-UP VISITS

TABLE 10: PATTERN OF ULCER HEALING IN DUSS SCORE 4 IN FOLLOW-UP VISITS

TABLE 11: COMPARISON OF DUSS SCORE WITH OUTCOMES

TABLE 12: DISTRIBUTION OF MAJOR AND MINOR AMPUTATIONS

TABLE 13: DISTRIBUTION OF OUTCOMES FOR EACH DUSS SCORE

TABLE 14: COX REGRESSION ANALYSIS

Age: The most common age group affected in this study was 51 to 60 years (34%). It was followed by 41 to 50 years (24%). The least number of participants belonged to the age group 81 to 90 years (2%). The mean age was 56.93 years. The standard deviation was 11.09 years. The minimum age among the participants in the study was 33 years and the maximum age was 89 years. Comparison with previous studies: In the study done by Beckert et al,8 the study was done on 1000 diabetic foot ulcer patients. The mean age was 69 years. The minimum age among the participants was 26 years and the maximum was 95 years.

Sex: In the present study the male participants were 66% and female participants were 34%. The males were more when compared to females in this study which shows more incidence of diabetic foot ulcers in the males compared to females. Comparison with previous studies: In the study by Beckert et al,8 males were more than females. Males-675 (67.5%), Females-325 (32.5%). It is comparable to the results of present study that males are affected more than females with diabetic foot ulcers. It could be due to the nature of work and resulted increase chances of trauma to the tissues.

Alcohol and habit of smoking: In the present study, out of 100 participants there were 34% alcoholics and 54% had a habit of smoking. These were not compared in the previous studies but could play a role in the disease process.

History of Diabetes: In the present study, history of diabetes was noted in 65% of the participants. The rest were newly diagnosed at the time of first visit. This study was aimed at diabetic patients. The results showed 35% of them were not aware of the disease. It could be a reason for late presentation of diabetic foot patients as a significant number of patients were unaware of the disease process already going on inside. Comparison with previous studies: In the study done by Beckert et al,8 all the 1000 patients. The study was done on already diagnosed with diabetes. Thus, this could not be compared with the present study results regarding undiagnosed diabetic patients.

In the present study, all 100 participants were assessed for diabetic foot ulcers and the following parameters are noted i.e., number of ulcers, location of ulcer, probing to bone and pedal pulses. The DUSS score was calculated, the score can be ranging from 0 to a maximum of 4.

DUSS score: In the present study the maximum number of participants had the DUSS score 2 (41%). It was followed by DUSS score 3 (21%). The DUSS score 0 was seen in least number of participants (8%).

Period of follow-up: The 100 participants are followed up weekly and the DUSS score was assessed on every visit. The maximum number of days of follow-up visits were noted in the group with DUSS score 0 (23.6±6.4 days). It was followed by group with DUSS score 2 (23±10.6 days). The least number of days to outcome was noted in the group with DUSS score 4 (8.9±4.5 days).

Outcomes: In the present study, the outcomes were noted as follows. Out of 100 participants, 38% of the diabetic foot ulcers had complete healing, and 9% had healing by SSG (split skin grafting). Thus, accounting for 47% of participants who had complete healing as the final outcome in the present study.

In the present study the amputations both major and minor amputations account for 53% of the participants in the study which were further divided as follows Toe disarticulation – 23% Forefoot amputation – 3% BKA – 23% AKA – 4% Thus, in the present study, major amputations were noted in 27% of the participants which includes Below Knee Amputation (BKA) in 23% of the participants and Above Knee Amputation (AKA) in 4% of the participants and minor amputations were noted in 26% of the participants which includes toe disarticulation and fore foot amputations.

When compared with the DUSS score of patients having amputation as the final outcome including both major and minor amputations, it is noted that patients with DUSS score 4 in the present study had 100% amputations. Followed by patients with DUSS score 3 which had 90.5% amputation and DUSS score 2 with 47.4% amputations. In the present study the patients with DUSS score 3 had the greatest number of major amputations i.e. 17 with accounted for 63% of all major amputations in the present study. This was followed by the group with DUSS score 4 with 10 major amputations, which accounted for 37% of all major amputations in the present study. The patients with DUSS score 2 had the greatest number of minor amputations i.e. 12 which accounts for 46.2% of all minor amputations in the present study.

Comparison with previous studies: In the study by Beckert,8 the total amputations were 125. Out of these major amputations were 2.6% and minor amputations were 9.9%. The patients with DUSS score 3 had 11.2% major amputations followed by DUSS score 4 with 3.8% major amputations. This study had more minor amputations than major amputations. This trend was not seen in the present study as both major and minor amputations were almost equal in number.

In Beckert study: Major amputations – 26; Minor amputations – 99. In present study: Major amputations – 27; Minor amputations – 26. Statistical analysis: In the present study the relation between the DUSS score and the final outcomes was compared by using Cox Regression analysis. The cox regression analysis showed the influence of variables on the outcome. In the present study we compared the influence of DUSS score on the outcome of major amputation and the p-value is noted to measure the statistical significance. The patients with DUSS score 0 showed p-value of 0.0432 which was statistically significant. The patients with DUSS score 3 showed p-value of 0.0473 which was statistically significant.

The patients with DUSS score 4 showed p-value of 0.0010 which was statistically significant. The patients with DUSS score 1 and DUSS score 2 showed p-value >0.05 which were not statistically significant. Thus, patients with DUSS score 0,3 and 4 showed strong correlation to the outcome of major amputation in this study with statistically significant p-values. In the present study the Kaplan-Meier analysis was used to show relation between DUSS score and probability of healing. In the present study, patients with DUSS score 0 had maximum probability of healing of 75%.

It was followed by patients with DUSS score 2 with 70% probability of healing. In the present study the patients with DUSS score 4 showed 0% probability of healing. Comparison with previous studies: In the study by Beckert et al8, the patients with a DUSS score of 0 had no risk of major amputation. The patients with a DUSS score 1 had a 2.4%, DUSS score of 2 had a 7.7%, DUSS score of 3 had an 11.2%, and DUSS score of 4 had a 3.8% probability of amputation. In the study by Beckert et al 8 the probability of healing was showed by Kaplan-Meier analysis. The patients with DUSS score 0 had 93% probability of healing. The patients with DUSS score 4 had 57% probability of healing. Thus, with increasing DUSS score there was a decrease in the probability of healing which was also observed in the present study.

Diabetic ulcer severity score (DUSS) scoring system developed by Beckert et al, provides an easy wound based diagnostic tool which can be used for predicting probability of healing or amputation of diabetic foot ulcer patients by combining four simple bed-side clinically wound based parameters namely number of ulcers, site of ulcer, probing to bone, pedal pulses. By this score patients can be stratified accordingly depending on severity of ulcer. This is a simple and easy scoring system which needs no special investigations or equipment with advanced function and can be easily followed even in busy OPDs in the peripheral medical facilities.

Based on the score, patients can be counselled and treated based on the risk in an even better way. If the score is high as the patient needs advanced wound care he/she can be referred to a higher center with needed facilities. The present study showed the DUSS score can predict the outcome of the diabetic foot ulcers. The cox regression showed that score 0, 3 and 4 had statistically significant results showing the prediction of major amputation. The Kaplan-Meier analysis showed that in the present study score o had maximum chance of healing 75% followed by score 2 with 70% and score 4 had 0% chance of healing.

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