SYNOPSIS
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE
“study of EFFICACY OF TOPICAL insulin APPLICATION IN WOUND healing in diabetic ulcers”
Name of the candidate : Dr. VIJIN V.
Guide : Dr. P.S.M.AITHALA
Course and Subject : M.S. (GENERAL SURGERY)
DEPARTMENT OF GENERAL SURGERY
FATHER MULLER MEDICAL COLLEGE,
KANKANADY, MANGALORE – 575002.
2011
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / Name of the Candidate and Address[in block letters] / Dr. VIJIN V.
PG IN GENERAL SURGERY
FR. MULLER MEDICAL COLLEGE
KANKANADY
MANGALORE – 575002
2. / Name of the Institution / FATHER MULLER MEDICAL COLLEGE
KANKANADY
MANGALORE – 575002.
3. / Course of study and subject / MASTER OF SURGERY
GENERAL SURGERY
4. / Date of admission to Course / 01-04-2011
5. / TITLE OF THE TOPIC:
“study of EFFICACY OF TOPICAL insulin APPLICATION IN WOUND healing in diabetic ulcers”
6 / 6.1 NEED FOR THE STUDY
Diabetes the global epidemic is rapidly increasing at an alarming rate more so with India with the Westernization of the society. Diabetes Mellitus exerts a heavy economic burden on society. This burden is related to health system costs incurred by society in managing the disease, indirect costs resulting from productivity losses due to patient disability and premature mortality, time spent by family members accompanying patients when seeking care, and intangible costs like psychological pain to the family and loved ones. Foot complications are common in diabetic patients and are considered one of the most expensive diabetes (DM) complications to treat. The diabetic foot is profoundly susceptible to a multitude of insults that may result in disease. This susceptibility is secondary to an impaired vascular and neurological state. This state of impairment can affect any component of the foot. The clinical findings of the diabetic foot include nail deformities, callus formation, skin lesions, foot ulcers and ultimately, the involvement of bone, although a proportion of people with PN and PVD have severe and debilitating pain, many are asymptomatic. However, despite the lack of symptoms, people with PN and PVD are known to be at high risk of foot complications including foot ulceration, infection and amputation. PN and PVD are the main causes of non-traumatic lower limb amputation.
The costs of diabetic foot lesions are influenced by interventions to prevent the development of foot ulcers, by management strategies to shorten wound-healing time, by strategies to prevent amputation for patients with current ulcers, and by the management and care required by disability following amputations
Wound healing is a complex biological process influenced by several agents such as insulin-like growth factor (IGF) and human acidic fibroblast growth factor (rh-aFGF).In vivo studies have shown that IGF can stimulate the proliferation and differentiation of endothelial cells and fibroblasts and promote granulation tissue regeneration to contribute to wound healing Ever since Bunting’s discovery of insulin in 1921,many benefits beyond blood glucose regulation have been documented. Preclinical and clinical studies have demonstrated positive effects of insulin on wound healing, but no suitable method for routine clinical use of topically applied insulin has been reported. Hence we have decided to study the effect of insulin on healing on diabetic foot and to develop an appropriate method for topical application of insulin.
6 / 6.2 REVIEW OF LITERATURE:
World Health Organization estimates that more than 180 million people worldwide have diabetes mellitus (1). One in every five diabetics in the world is an Indian making India known as the ‘diabetes capital’ of the world India is at the top of the diabetes projections list – with a massive 79.4 million people affected by 2030, with a current national diabetes prevalence of 4.3% and costs already reaching US$2.2 billion, diabetes poses a major threat to India’s emerging economy. (2)
Between 5-10 percent of all diabetics will, at some time in their life have an ulceration of their lower extremities Various other benefits of insulin beyond blood glucose regulation have been documented (3) Preclinical and clinical studies have demonstrated positive effects of insulin on wound healing 4. In a study by Greenway he described a method of creating uniform wounds in humans acceptable to an institutional review board, thus solving one of the major impediments to the scientific evaluation of human wound healing and also showed that concluded that topical insulin accelerates wound healing in humans.(5,6)
6.3 OBJECTIVES OF THE STUDY:
To study the efficacy of topical application of topical insulin on wound healing in diabetic foot infections and to develop an appropriate method for topical application of insulin.
7. / MATERIALS AND METHODS:
7.1 Source of Data:
Patients in Fr. Muller Medical College Hospital, Mangalore between May 2011 to September 2013 with Diabetic foot infections.
7.2 Method of Collection of Data:
Study type:
Prospective study
Sample and Sampling Technique
The study is estimated to include 50 patients who present with Diabetic foot infections at Father Muller hospital with purposive sampling technique.
A complete detailed history physical evaluation relevant blood investigations, radiological investigations will be done and correlated with Wagner’s grade II-IV and patients will be grouped accordingly.
Data Collection :
Age of the patient. Symptoms and their duration, Past history, Complete physical examination, Laboratory investigations, Radiological investigations wherever necessary, Treatment given, Complications. Duration of hospital stay and Time for healing of wound.
Inclusion Criteria :
· All patients above 20yrs who are diagnosed to have Diabetic foot infections
Exclusion Criteria:
· Patients who have been operated for Diabetic foot infections earlier
· Ulcers of wagners grade V
· Xrays showing features of osteomyelitis
· Doppler showing gross atherosclerotic arterial changes and venous abnormaliites like varicosities
· Malnutrition and uncontrolled diabetes
· Other clinally significant medical conditions that would impair wound healing includingrenal .hepatic ,hematological ,neuroligcal and immunological diseases.
· Patients receiving corticosteroids , immmunosupressive agents , radiation , or chemotherapy within one month prior to entry into study were also excluded.
Plan for Data - Analysis
Collected data will be analysed by ANOVA for repeated measures and
Chi - Square test.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals?
Yes.
7.4 Has ethical clearance been obtained from your institution in case of 7.3
Yes.
8 / REFERENCES
1. World Health Organization. Diabetes Fact Sheet. 2008; Available at: http://www.who.int/mediacentre/factsheets/fs312/en/. Accessed December 17, 2008.
2. Siegel K, Narayan KM, Kinra S. Finding a policy solution to India’s diabetes epidemic. Health Aff (Millwood) 2008; 27: 1077–90.
3. Duckworth WC, Fawcett J, Reddy S, Page JC. Insulin-degrading activity in wound fluid. J Clin Endocrinol Metabol. 2004;89:847–851
4. Pierre EJ, Barrow RE, Hawkins HK, et al. Effects of insulin on wound healing, J Trauma Inj Infect Crit Care. 1998; 44:342.
5. Greenway SE, Filler LE, Greenway FL Topical insulin in wound healing: a randomised, double-blind, placebo-controlled trial. J Wound Care 1999 Nov;8(10):526-8
6. Gabriel A, Shores J, Heinrich C, et al. Negative pressure wound therapy with instillation: a pilot study describing a new method for treating infected wounds. Int Wound J. 2008; 5(3):399–413.
7. S. Guo , L.A. DiPietro ,Factors Affecting Wound Healing ,Journal of dental research ,JDR March 2010 vol. 89 no. 3 219-229.
9. / Signature of the candidate
10. / Remarks of the guide / Satisfactory.
11. / Name and Designation of
(in block letters)
11.1 Guide / Dr. P.S AITHALA
PROFESSOR & HEAD OF THE DEPARTMENT
DEPARTMENT OF GENERAL SURGERY,
FR. MULLER MEDICAL COLLEGE,
KANKANADY, MANGALORE. -2
11.2 Signature
11.3 Head of the Department / Dr. P.S AITHALA
PROFESSOR & HEAD OF THE DEPARTMENT
DEPARTMENT OF GENERAL SURGERY,
FATHER MULLER MEDICAL COLLEGE AND HOSPITAL
KANKANADY, MANGALORE-2
11.4 Signature
12. / 12. 1 Remarks of the Chairman and Dean
12.2 Signature
. Gabriel A, Shores J, Heinrich C, et al. Negative pressure wound therapy with instillation: a pilot study describing a new method for treating infected wounds. Int Wound J. 2008;5(3):399–413