Topical Insulin Therapy for Enhanced Wound Healing: An Open-Label Randomized Controlled Clinical Study

Abstract

Background:

Wounds cause consequently significant negative implications on the socio-economic and psychological aspect of an individual as well as the whole society, globally. The purpose of this study was to develop, cost-effective, easily accessible therapeutic options to promote wound healing.

Methods:

This open-label, single-centric randomised controlled study enrolled 82 patients. Patients were divided as 2 groups A and B to receive topical insulin and normal saline respectively. For effectiveness evaluation change in mean surface area (SA), percentage reduction in wound SA, pace and depth of granulation tissue and reduction in visual analog pain score (VAS) was noted.  For safety evaluation adverse drug reactions (ADRs) were noted.  Statistical analysis included both descriptive and inferential statistics such as repeated measures one way ANOVA.

Results:

A statistically significant difference in mean Surface area, wound depth and VAS over time with large effect size; groups (F (3.214, 130.166) = 12.478, p < 0.0005, ηp² = 0.210), (F (2.113, 85.589) = 2.132, p < 0.05, ηp² = 0.040) and (F (3.618, 146.52) = 14.960, p < 0.0005, ηp² = 0.462) respectively was observed.   Also, Group A (M = 4.14.90, SD = 1.13) reported significantly lesser time to granulation tissue formation than Group B (M = 9.48, SD = 1.62), t (71) = 17.244, p <0.0005, d = 3.82 and greater percentage reduction in wound SA (M = 36.70, SD = 11.45) than Group B (M = 14.87, SD = 12.36), t (80) = 8.29, p <0.0005, d = 1.83. Additionally, no major ADRs were observed in both the groups.

Conclusion:

Topical insulin receiving group demonstrated good wound healing as compared to the saline group. Additionally, topical insulin demonstrated a good safety profile. However, large scale multi-centric studies in future can build up on this pre-liminary research.