Date of Award

Winter 1-4-2020

Document Type

Dissertation

Degree Name

PharmD

Department

Department of Pharmacy Practice

First Advisor

Dr. Gabriel Sunil Rodrigues

Abstract

Background: Diabetic foot ulcers (DFUs) are one of the major complications of poorly controlled diabetes. The DFUs result due to the damage and breaking of the skin beneath it. The most commonly affected locations of DFUs are the extreme proximities of the toes. The wounds associated with foot ulcerations are the leading causes of the leg amputation. Metformin, a widely used anti- diabetic agent has a vital role in AMPK activation as well as plays an inhibitory effect on the mTOR, and Cyclin D1 pathways. Thereby causing a delay in the usual process of healing of wound in the patients. Therefore, purpose of the study was understanding metformin effect on wound healing in DFU patients. Objectives: The primary study objective was to determine metformin effect on wound healing in DFU patients. Secondary objective was to assess the health-related quality of life (HRQOL) and investigate general prescribing practices for the management of DFU. Methods: A prospective cohort study was carried out for a period of 7 months (August 2019 to February 2020). A total of 76 patients with old and new diabetic foot infections and gangrene were recruited based on the inclusion and exclusion criteria. Patients were selected into two cohorts: DFU patients receiving metformin and its combinations were considered as study cohort and patients receiving any other anti-diabetic drug therapy were considered reference cohort. These patients’ wound diameters, sugar profile and healing time were monitored with a follow up after 4 months. All the patients were provided with a quality of life (QoL) tool - diabetic foot ulcer scale- Short form questionnaire (DFS-SF). Additionally, the prescription patterns of the DFU patients were also evaluated. IBM (SPSS) version.25.0 was used for statistical analysis and p <0.05 was considered as statistically significant. Results: A statistically significant association was found between delay in wound healing and metformin use (X2= 4.846; p = 0.028). Similarly, a statistically significant association was found with amputations and metformin use (X2= 4.31, p = 0.038). QoL scores between male and female showed that men had better mean scores in domains of health (61.3 ± 3.30), dependency (56.7 ± 3.54) and bothered by ulcers (61.9 ± 2.87). Whereas, women had better mean scores in the physical domains of leisure (67.5 ± 7.78), daily life (69.8 ± 8.52) and psychological domains of negative emotions (48.6 ± 6.57) and worried by ulcers (61.5 ± 7.17). 72.7% of the study cohort patients received insulin, whereas 100% of the reference cohort patients received insulin. The penicillin was the commonly prescribed antibiotic class in study cohort (52.3%) and reference cohort (71.8%). Conclusion: Study shows a significant delay in the process of healing of wound in DFU patients on metformin compared to patients on other anti-diabetic therapy. Most importantly, a higher incidence of lower extremity amputations was seen in metformin group compared to another anti-diabetic agent group. The prescribing patterns of the drugs showed that insulin was the most commonly antidiabetics, whereas penicillin was the most commonly prescribed antibiotics in DFU patients.

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