Testing And Validating Amit Jain’s Classification And Scoring System For Diabetic Foot Complications

t Jain’s Classification And Scoring System For Diabetic Foot Complications Amit Kumar C Jain1, Rajagopalan2, Gopal S3 1Associate Professor, Department Of Surgery, Rajarajeswari Medical College, Bangalore, India 2 Professor and HOD, Department Of Surgery, Rajarajeswari Medical College, Bangalore, India 3Assistant Professor, Department Of Surgery, Rajarajeswari Medical College, Bangalore, India Correspondence Author: Dr. Gopal S, Assistant Professor, Department Of Surgery, Rajarajeswari Medical College, Bangalore, India Type of publication: Original Research Paper Conflicts of Interest: Nil Abstract AIM - The study aims at testing and validating Amit Jain’s classification and Amit Jain’s scoring system for diabetic foot complication. Methods And Materials - A prospective descriptive analysis was done in Department of Surgery of Rajarajeswari medical college, Bangalore, India.The study period was for one year from January 2017 to December
Keywords: Diabetic foot, Amit Jain’s, Classification, Scoring, Amputation

Introduction

The incidence of diabetes around the world has quadrupled in last 30 years with 422 million of people now diagnosed with disease, increasing the global prevalence from 4.7% to 8.5% [1]. However, the burden of diabetes is likely to be greater than current forecasts [2]. Diabetic foot is considered to be one of the most significant complications of diabetes, representing a major worldwide medical, social and economic problem that greatly affects the quality of life of the patient [3]. The morbidity and mortality associated with diabetic foot problem remains extremely high [4]. It is estimated that around 15% of people with diabetes will develop foot ulcers during their lifetime [2, 5]. A number of foot ulcer classification systems have been devised over years to categorize ulcers more effectively [6]. Amit Jain’s classification for a diabetic foot complication [Table1] is a new modern comprehensive Page 227 Corresponding Author: Dr. Gopal S, Volume – 3 Issue – 1, Page No. 227 – 236 Amit Kumar C Jain, et al. International Journal of Medical Sciences and Innovative Research (IJMSIR) © 2018 IJMSIR, All Rights Reserved Page228 Page228 Page228 Page228 Page228 Page228 Page228 Page228 Page228 Page228 Page228 Page228 Page228 Page228 Page228 Page228 Page228 Page228 Page228 classification for diabetic foot that divides diabetic foot into 3 simple types [2, 5, 7, 8]. Amit Jain’s scoring system [Table 2] is a new surgical scoring system that predicts a risk of major amputation in diabetic foot [9, 10]. This study aims at testing and validating Amit Jain’s classification and Amit Jain’s scoring system for diabetic foot complication.

Methods And Materials

A prospective descriptive analysis was done in Department of Surgery of Rajarajeswari medical college, Bangalore, India. This is a tertiary care teaching hospital mainly serving rural population. The study period was for one year from January 2017 to December 2017. All the patients admitted and operated for diabetic foot
complication were included in the study and their data was entered in study performa. The following were the exclusion criteria

1] Patients who refused surgery and were discharged against medical advice

2] Patients operated in other specialty department

3] Patients operated elsewhere

4] Patients admitted for skin grafting The study was approved by our institutional ethics committee [RRMCH-IEC/157/2016-17]

Statistical Methods:

Descriptive and inferential statistical analysis has been carried out in the present study. Results on continuous measurements are presented on Mean ± SD (Min-Max) and results on categorical measurements are presented in Number (%). Significance is assessed at 5 % level of significance. The following assumptions on data is made, Assumptions: 1.Dependent variables should be normally distributed, 2.Samples drawn from the population should be random, Cases of the samples should be independent Student t test (two tailed, independent) has been used to find the significance of study parameters on continuous scale between two groups (Inter group analysis) on metric parameters. Leven1s test for homogeneity of variance has been performed to assess the homogeneity of variance. Analysis of variance (ANOVA) has been used to find the significance of study parameters between three or more groups of patients Chi-square/ Fisher Exact test has been used to find the significance of study parameters on categorical scale between two or more groups, Non-parametric setting for Qualitative data analysis. Fisher Exact test used when cell samples are very small.

Significant figures

+ Suggestive significance (P value: 0.05<P<0.10)

* Moderately significant ( P value:0.01<P ≤ 0.05)

** Strongly significant (P value : P≤0.01)

Statistical software: The Statistical software namely SPSS 18.0, and R environment ver.3.2.2 were used for the analysis of the data and Microsoft word and Excel have been used to generate graphs, tables etc.

Results

total of 61 patients were included in this study. Majorityof the patients were males [73.8%] in this study [Table 3]. Most patients were in age [Table 4] ranging from 5 to 60 years [56.92+/-11.92]. Left foot was the commonest side involved affecting 38 patients [62.3%].

Wet gangrene [Table 5] was most common pathological lesion seen in 24.6% followed by abscess [Fifure 1]] which was seen in 23%. Majority of the patients thus
belonged to Type 1 diabetic foot complications [67.2%] followed by type 3 diabetic foot complication [29.5%] and it was statistically significant (P<0.001). Debridement is  the most common surgical procedure done [Table 6]. 32 patients [52.5%] had some type of amputation being performed. There was no significant association between amputation done [Table 7] and type of diabetic foot Amit Kumar C Jain, et al. International Journal of Medical Sciences and Innovative Research (IJMSIR)

© 2018 IJMSIR, All Rights Reserved

complication [P+0.241]. Among amputations, 6 patients [9.8%] had major amputation [Table 8].

Majority of diabetic foot patients [68.9%] had a score between 6 to 10 and were in low risk category of major amputation. It was seen that, with increasing score, the risk of major amputation [Table 9] increased significantly [P<0.001]. There were 6 major amputation with all having score above 16. All patients who had score above 25 invariably had major amputation done. Patients with type 2 diabetic foot complication [Table 10] had higher scores compared to other complication suggesting significance [19.50+/-10.61, P-0.040].

.Majority of patients [34.4%] had diabetes [Table 11] of 6-10 years duration [8.57+/- 6.68]. 42.6% had associated hypertension [Table 12], 4.9% had chronic kidney disease [Table 13] and 9.8% had ischemic heart disease [Table 14]. It was seen that patients with type 3 diabetic foot complication had longer duration of diabetes suggesting some significance [10.89+/-7.53, P-0.088]. There were two mortality [Table 15] in this study and it was associated with high scores {22.00+/-11.31, P<0.001} and it was statistically significant [Table 16].

Discussion

Various classifications and scoring system have been proposed in diabetic foot with most of them focusing only on diabetic foot ulcers [2, 5, 7, 8]. Some of the  classifications are Wagner’s classification, University of Texas classification, PEDIS classification whereas some of the known scoring system are DEPA scoring system, DUSS, etc [2, 5, 7, 8, 11, 12].

It is now clear that there is a difference between a classification and a scoring system [12]. A classification is descriptive in nature, whereas a score is a numerical descriptor and is usually meant to provide an idea of severity [12]. It is also well known that it is very difficult for a single classification system to effectively serve both these purposes [12]. Therefore, the current study employed Amit Jain’s classification for diabetic foot complications along with Amit Jain’s scoring system, which predicts the risk of major amputation in diabetic foot complications [7,8,9,10].

The Amit Jain’s classification for diabetic foot complications was first proposed in 2017 and was the first classification to encompass all lesions seen universally [7,8,13,14]. Initially, no studies were conducted on this classification at the time of its proposal [7]. Subsequently, many new studies evaluated this classification, and various studies demonstrated that type 1 diabetic foot complications were the most common cause of hospital admission [13,14,15]. In the series by Jain et al., it was observed that 86.67% of admitted patients had type 1 diabetic foot complications, whereas in the series by Kalaivani et al., this figure was 91.06% [13,15]. Wet gangrene and abscess were the most common lesions reported across different studies [2,13,14,15]. Similarly, in the present series, wet gangrene followed by abscess were the two most common lesions encountered. More than 67% of the patients had type 1 diabetic foot complications, which was found to be statistically significant in this study.

The majority of studies have shown that the most common reason for major amputation is type 1 diabetic foot complication [2,13,15]. In the present study as well, major amputation was most commonly associated with type 1 diabetic foot complications. In a validation study of Amit Jain’s scoring system by Kalaivani et al. [16], it was observed that more than 85.7% of patients who underwent major amputation had a score greater than 16. Similarly, in the series by Jain et al., more than 80% of patients with major amputation had a score of 16 or above [17].

In our series, we found a significant association between Amit Jain’s scoring system and major amputation, with higher scores being associated with an increased incidence of major amputations. Furthermore, a significant association was also observed between higher scores and mortality. Type 2 diabetic foot complications demonstrated significantly higher scores overall when compared to other types of diabetic foot complications. In the series by Jain et al. [17] on the scoring system, mortality was similarly associated with higher scores. Additionally, stump complications following major amputation were more commonly observed in patients with type 1 diabetic foot complications and were predominantly seen in those with higher scores, as reported in earlier studies [10]. Despite the numerous studies conducted on Amit Jain’s classification over the past four to five years, a recent review by Nather et al. [18] on diabetic foot classifications failed to analyze or include these studies on Amit Jain’s classification.

Conclusion

In this validation study, it is clearly seen that type 1 diabetic foot complications accounts for significant number of cases admitted in hospitals with wet gangrene and abscess being the commonest lesions seen. Most of the major amputations were performed in type 1 diabetic foot complication. It was found that with increasing scores for diabetic foot, there was statistically significant increase in major amputation. Patients with mortality also had significant higher scores. With already many studies done on Amit Jain’s classification and scoring system, further studies in future on this combined classification and scoring done from different center’s will lend creditability and provide new data.

References

  1. Gulf Diabetic Foot Working Group. Identification and management of infection in diabetic foot ulcers: International Consensus. Wounds International. 2017.

  2. Singh M, Sahu A. Analyzing diabetic foot complication according to modern comprehensive Amit Jain classification from Indian subcontinent in a government care setting. IJCMAAS. 2017;13(3):125–130.

  3. Doupis J, Veves A. Classification, diagnosis and treatment of diabetic foot ulcers. Wounds. 2008;20(6).

  4. Jeffcoate WJ, Chipchase SY, Ince P, Game FL. Assessing the outcome of the measurement of diabetic foot ulcers using ulcer-related and personal-related measures. Diabetes Care. 2006;29:1784–1787.

  5. Dhubaib H. Understanding diabetic foot complications: In praise of Amit Jain’s classification. Diabetic Foot Journal Middle East. 2015;1(1):10–11.

  6. Parisi MCR, Wittmann DEZ, Pavin EJ, et al. Comparison of three systems of classification in predicting the outcome of diabetic foot ulcers in a Brazilian population. European Journal of Endocrinology. 2008;159:417–422.

  7. Jain AKC. A new classification of diabetic foot complications: A simple and effective teaching tool. Journal of Diabetic Foot Complications. 2012;4(1):1–5.

  8. Jain AKC, Joshi S. Diabetic foot classifications: Review of literature. Medicine Science. 2013;2(3):715–721.

  9. Jain AKC. The new scoring system for predicting the risk of major amputations in patients with diabetic foot complications. Medicine Science. 2014;3(1):1068–1078.

  10. Jain AKC, Viswanath S. Analysis of stump complications following major amputation in diabetic foot complications using Amit Jain’s principle and practice for diabetic foot. Scholars Journal of Applied Medical Sciences. 2016;4(3E):986–989.

  11. Rosner B. Fundamentals of Biostatistics. 5th ed. Duxbury; 2000:80–240.

  12. Riffenburg RH. Statistics in Medicine. 2nd ed. Academic Press; 2005:85–125.

  13. Sunder Rao PSS, Richard J. An Introduction to Biostatistics: A Manual for Students in Health Sciences. 4th ed. New Delhi: Prentice Hall of India; 2006:86–160.

  14. Suresh KP, Chandrasekhar S. Sample size estimation and power analysis for clinical research studies. Journal of Human Reproductive Sciences. 2012;5(1):7–13.

  15. Schaper NC. Diabetic foot ulcer classification systems for research purposes: A prognosis report on criteria for including patients in research studies. Diabetes/Metabolism Research and Reviews. 2004;20(Suppl 1):S90–S95.

  16. Game F. Classification of diabetic foot ulcers. Diabetes/Metabolism Research and Reviews. 2016;32(1):186–194.

  17. Jain AKC, Viswanath S. Distribution and analysis of diabetic foot. OA Case Reports. 2013;2(21):117.

  18. Singh M, Singh AR. Evaluation and management of diabetic foot complications using Amit Jain’s classification: An exploration of use. Diabetic Foot Journal Middle East. 2016;2(1):16–19.

  19. Kalaivani V. Evaluation of diabetic foot complications according to Amit Jain’s classification. Journal of Clinical and Diagnostic Research. 2014;8(12):7–9.

  20. Kalaivani V, Melanta K. Application of Amit Jain’s scoring system in diabetic foot amputees. Journal of Evolution of Medical and Dental Sciences. 2016;5(28):1413–1417.

  21. Jain AKC, Viswanath S. Studying major amputation in a developing country using Amit Jain’s typing and scoring system for diabetic foot complications: Time for standardization of diabetic foot practice. International Surgery Journal. 2015;2(1):26–30.

  22. Nather A, Jun WY, Juan SL. Choosing a classification for the management of patients with diabetic foot problems. Orthopaedic Surgery and Traumatology. 2017;1(3):104–110.

FIGURES

Figure 1: Showing Right Side Diabetic Foot Abscess. This Is Amit Jain’s Type 1 Diabetic Foot Complication

Tables and Graphs

Table 1: Amit Jain’s classification for diabetic foot complication.
Table 2 –Amit Jain’s scoring system
SL. NO CHARACTERISTICS INVOLVEMENT OF FOOT
1] PRESENCE OF ULCER NO ULCER → 0 FOOT ULCER → 2 MIDFOOT ULCER → 4 HINDFOOT ULCER / FULL FOOT / BEYOND → 6
2] OSTEOMYELITIS (O.M) NO O.M → 0 FOREFOOT O.M → 2 MIDFOOT O.M → 4 HINDFOOT O.M → 6
3] PRESENCE OF PUS NO PUS → 0 FOREFOOT PUS / DORSUM → 2 MIDFOOT PUS → 4 HINDFOOT PUS / BEYOND IT → 6
4] GANGRENE (DRY / WET) NO GANGRENE → 0 FOREFOOT GANGRENE → 2 MIDFOOT GANGRENE → 4 HINDFOOT GANGRENE / BEYOND → 8
5] PERIPHERAL ARTERIAL DISEASE NO P.A.D → 0 MILD → 2 MODERATE → 4 SEVERE → 8
6] CHARCOT FOOT / DESTROYED JOINTS NO → 0 FOREFOOT → 2 MIDFOOT → 4 HINDFOOT / WHOLE FOOT → 8
7] NECROSIS (SKIN) NO → 0 FOREFOOT NECROSIS → 2 MIDFOOT NECROSIS → 4 HINDFOOT NECROSIS / BEYOND → 8
8] ASSOCIATED CELLULITIS NO → 0 UPTO FOREFOOT → 2 UPTO MIDFOOT → 4 UPTO HINDFOOT & BEYOND → 6
9] PREVIOUS AMPUTATION NO → 0 TOE AMPUTATION FOREFOOT AMPUTATION MIDFOOT AMPUTATION → 6
10] PRESENCE OF GAS RADIOLOGICA LLY N NO → 0 AS IN FOREFOOT 1 GAS IN/UPTO MIDFOOT 2 AS IN/UPTO HINDFOOT → 3
Table 3: Gender distribution of patients studied
Gender No. of patients %
Male 45 73.8
Female 16 26.2
Total 61 100.0
Table 4: Age distribution of patients studied
Age in years No. of patients %
30–40 4 6.6
41–50 19 31.1
51–60 16 26.2
61–70 15 24.6
>70 7 11.5
Total 61 100.0
Table 5: Distribution of cases according to type of complication.

Table 6: Surgery distribution of patients studied

Surgery No. of patients %
Debridement 29 47.5
Toe amputations 15 24.6
Transmetatarsal amputation 11 18.0
Below knee amputation 2 3.3
Above knee amputation 4 6.6
Total 61 100.0
Amputati on done 1 2 3 Total
yes 19(46.3 %) 2(100 %) 11(61.1 %) 32(52.5 %)
No 22(53.7 %) 0(0%) 7(38.9%) 29(47.5n %)
Total 41(100%) 2(100%) 18(100%) 16(100%)
Table 7: Amputation done in relation to Type of complications of patients studied
Table 8: Not Significant, Fisher Exact Test Table 8: Major Amputation distribution of patients studied
Major Amputation No. of patients %
yes 6 9.8
No 55 90.2
Total 61 1000
Table 9:Score of Diabetic Foot Amputation in relation to Major amputation of patients studied
Table 10:Comparison of clinical variables according to Type of complications of patients studied
Variables Type of Complications 1 Type of Complications 2 Type of Complications 3 Total P value
Age (years) 56.93 ± 12.05 53.00 ± 10.24 57.33 ± 12.51 56.92 ± 11.92 0.891
DM Duration 7.90 ± 6.11 1.50 ± 0.71 10.89 ± 7.53 8.57 ± 6.68 0.08+
Score of Diabetic Foot Amputation 10.07 ± 5.47 19.50 ± 10.61 9.11 ± 4.50 10.10 ± 5.55 0.04*
Table 11: DM Duration distribution of patients studied
DM Duration (years) No. of patients %
1–2 14 23.0
3–5 9 14.8
6–10 21 34.4
11–15 8 13.1
16–20 6 9.8
21–25 2 3.3
26–30 1 1.6
Total 61 100.0
Table 12: Hypertension distribution of patients studied
Hypertension No. of patients %
yes 26 42.8
No 35 57.4
Total 61 1000
Table 13: CKD distribution of patients studied
CKD No. of patients %
yes 3 4.9
No 58 95.1
Total 61 1000
Table 14: IHD distribution of patients studied
IHD No. of patients %
yes 6 9.8
No 55 90.1
Total 61 1000
Table 15: Mortality distribution of patients studied
Mortality No. of patients %
yes 2 3.3
No 59 96.7
Total 61 1000
Table 16: Comparison of scores with Mortality of patients studied
variables Yes No Total P value
Score of Diabetic Foot Amputation 22.00± 11.31 9.69±4.9 6 10.10±5.5 5 0.001* *

AUTHORS’ CONTRIBUTIONS

Dr Amit Kumar- Data collection, Conceptualization, design and preparation of manuscript. Dr
Viswanath – critical revision and data collection.

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