A Randomised Controlled Trial To Compare Papain-Urea Based Preparation Vs Superoxidised Solution In The Management Of Grade 2-Diabetic Foot Ulcer

Abstract

Background and objectives Enzymatic ulcer debridement is effective in chronic nonhealing ulcers and it decrease exudates, bacterial burden and promote ulcer healing. This study was aimed to compare the effectiveness of Papainurea based preparation vs Superoxidised solution in debridement of grade 2 diabetic foot ulcers, as assessed by the appearance of granulation tissue on the end of day 21. Methodology This randomized controlled trial was done in the Department of General Surgery, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi over a period, from January 2015 to December 2015. A total of 60 Diabetic Patients taking insulin or oral hyperglycaemic and suffering from diabetic foot ulcers were enrolled. These patients were divided into two groups of 30 each that is First group (Group A) with superoxidised solution and Second group (Group B) with papain-urea based preparation. Results In the present study 80% of the patients in group A and 86% of the patients in group B were males. (p=0.488) The mean age in group A was 61.56 ± 13.00 years compared to 58.53 ± 11.40 years (p=0.341). It was observed that, majority of the patients in group A (70%) and group B (76.67%) has type 2 diabetes mellitus (p=0.559). The mean duration of diabetes in group A was 7.97± 5.65 years compared to 7.00 ± 4.18 years in group B (p=0.453). On day 21 significantly higher number of patients (73.33%) in group B had granulation compared to group A (46.67%) (p=0.035). It was observed that, wound area before dressing, on day five and day 10 was comparable. Even the reduction in wound area from day 21 to beginning of dressing was also comparable (p> 0.050). Conclusion and interpretation Papain-urea seems to be a better enzymatic debriding agent promotes faster granulation compared to superoxidised solution.