19 Appendix

APPENDIX 1. KAP questionnaire on diabetic foot care Knowledge Assessment (Total Score:10) 1. Is it true that all patients with diabetes develop reduced blood flow in their feet? 2. Is it true that all patients with diabetes develop lack of sensations in their feet? 3. Is it true that all patients with diabetes develop foot ulcers? 4. Is it true that all patients with diabetes develop gangrene? 5. Were you given any information regarding foot care? If yes, when….? 6. Are you aware that smoking can reduce blood flow in your feet? 7. Do you know that if you have loss of sensation on your foot, you are more prone to have foot ulcers? 8. Do you know that if you have reduced blood flow on your foot, you are more prone to get foot ulcers? 9. Do you know that if you have foot infection, you will develop foot wounds? 10. Which do you think is appropriate way of trimming your nail? Cutting along the edges/cutting straight through? Attitude Assessment (Total Score: 5) 1. Are you willing to change your food habits and do regular exercise to prevent further complications due to diabetes? 2. Do you think people with diabetes should take the responsibility of self foot examinations like checking sole of foot daily/wearing podiatrist prescribed footwear/consulting podiatrist regularly? 3. Are you willing to use special footwear prescribed your podiatrist? 4. Will you wear footwear indoors as advised by your podiatrist? 5. Do you think you can lead a normal life if you take appropriate measures for diabetes? Practice Assessment (Total score: 10) 1. Do you wash your feet daily? 2. Do you moisturize dry areas of your feet daily? 3. Do you check your feet daily for any injury? 4. What would you do if you find any abnormality on your feet? You manage yourself/consult a podiatrist? 5. Are your toe nails cut straight through regularly? 6. Do you check whether your shoes/socks leave marks on your feet? 7. How often do you change your footwear? When slippers are damaged/once in a year/more than once in a year? (Scores: 0,1 & 2) 8. How often do you go for foot check up? Once in a month/once in 6 months/once in a year/only during illness? (Scores: 0,1 & 2).

PAPER PRESENTATIONS / CONFERENCES 1. Poster presentation – Pilot study on the spectrum and prevalence of fungi in diabetic foot wounds, Vth Winter Symposium 2007, CMC, Vellore, South India 2. Best Presentation Award for the paper- Spectrum and Prevalence of Fungi Infecting Deep Tissues of Lower-Limb Wounds in Patients with Type 2 Diabetes, in Amrita Diabetic Foot Conference ADFC 2009, South India 3. Oral presentation- Magnitude of fungal infections in diabetic foot wounds. Endocrine Society of India Conference (ESICON) 2008, Kochi, South India 4. Oral presentation on the role of fluconazole in managing fungal infections in diabetic foot wounds. 20th FIP World Congress of Podiatry 2010, Amsterdam, Netherlands 5. Poster presentation on the spectrum and prevalence of fungal infections in diabetic foot wounds. 20th FIP World Congress of Podiatry, 2010, Amsterdam, Netherlands 6. 3rd Best Paper (Oral) Presentation Award, for the paper- Targeted treatment of invasive fungal infections accelerates healing of lower extremity wounds in patients with type 2 diabetes in National Conference of Research Society for Study of Diabetes in India (RSSDI) 2010, South India. 7. Fungal infections in Diabetic foot (invited talk). Diabetic Foot Society of India (DFSI), 2010 Bangalore, South India.

PUBLICATIONS 1. Gopi Chellan, Shashikala Shivaprakash, Sundaram Karimassery Ramaiyar, Ajit Kumar Varma, Narendra Varma, Mangalanandan Thekkeparambil Sukumaran, Jayakumar Rohinivilasam Vasukutty, Arun Bal, Harish Kumar. Spectrum and Prevalence of Fungi Infecting Deep Tissues of Lower-Limb Wounds in Patients with Type 2 Diabetes. Journal of Clinical Microbiology. 2010, 48 (6):2097–2102. 2. VU Menon, G Chellan, H Kumar, S Moorthy, KR Sundaram, RV Jayakumar. Normal thyroid volume and its determinants in healthy middle age and above

female population in central Kerala (Amrita Thyroid Survey). Thyroid Research and Practice. 2010, 7 (3): 76-83. 3. Gopi Chellan, Ajit Kumar Varma, K R Sundaram, Shashikala S, Kavitha R Dinesh, R V Jayakumar, Arun Bal, Harish Kumar. Footwear practices predict wound depth and foot infections among patients with type 2 diabetes. The Diabetic Foot Journal. 2011, 14 (2):72-79. 4. Dr. Srilakshmi, Dr. Gopi, Dr. Harish Kumar & Manoj. Saturn Dasa and Lower Limb Amputations. Modern Astrology. 2011, 2 (10): 372-398. 5. Dr.Srilakshmi, Manoj, Dr.Gopi Chellan, Dr.Sundaram, Dr.Harish Kumar. Role of afflicted Sun in Autoimmune Arthritis. Council of Vedic Astrology Journal. Sept 2011 Edition. 6. V Usha Menon, Gopi Chellan, KR Sundaram, Srikanth Murthy, Harish Kumar, AG Unnikrishnan, RV Jayakumar. Iodine status and its correlations with age, blood pressure and thyroid volume in South Indian women above 35 years of age (Amrita Thyroid Survey). Indian Journal of Endocrinology and Metabolism. 2011, 15(4):309-15. 7. Gopi Chellan, Neethu K, Shashikala Shivaprakash, Sundaram Karimassery Ramaiyar,

Ajit

Kumar

Varma,

Narendra

Varma,

Mangalanandan

Thekkeparambil Sukumaran, Jayakumar Rohinivilasam Vasukutty, Arun Bal, Harish Kumar. Targeted treatment of invasive fungal infections accelerates healing of lower extremity wounds in patients with type 2 diabetes. 2011. Diabetic Medicine (In Press). 8. Gopi Chellan, Ajit Kumar Varma, K R Sundaram, Shashikala S, Kavitha R Dinesh, R V Jayakumar, Arun Bal, Harish Kumar, Raja Biswas. Coexistance of fungi and bacteria in lower extremity wounds of patients with type 2 diabetes. 2011. Jounral of Medical Microbiology (In Press). 9. Gopi Chellan, Soumya Srikumar, Ajit Kumar Varma, Mangalanandan TS, K R Sundaram, R V Jayakumar, Arun Bal, Harish Kumar. Foot Care Practice – the key to prevent foot ulcer development among patients with type 2 Diabetes. 2011. Indian Journal of Medical Research (Under Review).

ANNEXURE 1 Rebuttal to the comments of International reviewer 1: 1. The literature review is rather comprehensive. The candidate would do well, however, to expand the information regarding the “wound microbiome” concept as well as “sociomicrobiology”. The discussion might further reinforce to the point that it might be bad communities, not just sinister individuals that effect negative changes. Answer: Human cells are accompanied by our personal “microbiome” of 100 trillion microorganisms that live symbiotically inside and on our bodies1. International Human Microbiome Project has put their effort to understand the extent to which our microbiomes are unique to each one of us as individuals and common to all of us as a species. It has been observed that these microorganisms have influenced our evolution. They are essential to our digestion, metabolism, and immunity. However, they also serve as the source of our infectivity2. Although bacterial colonization and/or infections are generally acknowledged to negatively impact wound healing, the precise relationship between the microbial community and impaired wound healing remains unclear. Studies have shown that host cutaneous defense responses play a key role in modulating microbial colonization. Correlation between relative abundance of Staphylococcus spp and the expression of cutaneous defense response genes and demonstrated that integrating two types of global data sets lends a better understanding to the dynamic governing host-microbe interactions3. “Sociomicrobiology”- bacterial populations often consist of heterogenous communities rather than genetically identical cells with synchronized gene expression profiles. It is thought that their social interactions might affect the evolution of antivirulence drug resistance during infections4. Studies have shown that with gross changes in the bacterial environment, such as the onset of infection, can profoundly perturb the sociomicrobiological structure of the bacterial population, driving a minor subpopulation with a mutant hypervirulent phenotype to thrive, prevail and cause severe disease5. Diabetic

foot infections are but one of the many complex features of otherwise peaceful coexistence. (Page 3&4) 2. The results are quiet compelling. The candidate would do well to the comment on the randomized control study portion of the thesis. Why did he choose an open label RCT? Certainly the assessor/treating physician could have been blinded in some fashion – or even the patient in some way. This should be explored a bit more in the discussion as well as in the methodology to prophylax against criticism and to increase enthusiasm. Answer: Yes, blinded RCT would have strengthened the study outcome. We did open label RCT because of the logistic reason such as non availability of placebo tablets which would mimic physical appearance of the marketed fluconazole tablet. To prevent examiners bias, we allowed a trained podiatry nurse (who was blinded about the treatment) to measure the wound surface area during patient visits (Page 34). 3. There are few modifications needed (other than what is mentioned above) to increase enthusiasm for this thesis. I would suggest that further work in getting these data out into the literature should be the primary goal (above and beyond the accepted or published works listed). Answer: Yes, earnest efforts are being put to bring our data into the literature. The list of papers published/ in press has been updated in the list of publications in page 86 & 87. Rebuttal to the comments of National reviewer 2: a) Social economic, psychological and educational status of the subjects may have improved our understanding. Answer: Yes, it would have been informative if we had looked into this aspect. However, these data was not collected as it was not included in our study objectives. We will certainly look into these parameters in our future studies. b) The duration from the ulcer occurrence to the medical advice was sought specially in those who required major amputations.

Answer: Details of wound site, duration, wound surface area at entry and end of the study; and time to complete wound healing of the study subjects is given in the table 4.3 (Page: 42)

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