A Prospective, NON Comparative, Multicenter Study to Investigate the Effect of Cadexomer Iodine on Bioburden Load and Other Wound Characteristics in Diabetic FOOT Ulcers

Background: Elevated bacterial burden has been cited as a causative factor in the delayed healing of DFUs.  Studies have shown critical colonization of DFUs with polybacterial flora.  While it is assumed that treating bacterial colonization speeds wound closure rate, few studies assess the actual bioburden in the wound during this course. 

 

Objectives:  Primary: To examine the effect of cadexomer iodine on bioburden in the diabetic foot ulcer (DFU). Secondary: To define the associated effect on wound closure and wound tissue types during the same period.

Methodology: A prospective two center, 6 week, non-comparative open label study of cadexomer iodine was carried out. 15 patients  had 16 Meggitt-Wagner grade 1 or 2 DFUs which appeared critically colonized and were greater than 2 cm in diameter.  The patients had adequate perfusion, and were excluded if they had chronic renal insufficiency. Quantitative cultures were  taken at weeks 0, 3 and 6. Planimetry and photography were carried out on a weekly basis.  

 

Key results:  A statistically significant reduction of 1.0 log¹⁰ (p= 0.025) was observed from baseline to 6 weeks. There was significant evidence (p= 0.008) of a reduction in the clinical signs of infection.  Median decreases in ulcer area and depth of 53.6% and 50%, respectively, were observed from baseline to 6 weeks. There were observed (NS) reductions in levels of exudate and pain from baseline to final assessment.

Conclusion: The bioburden reduction that was evident in the wounds treated with cadexomer iodine, had a much bigger impact on wound healing in those wounds with clinical infection than those without.  In the patients with infected wounds, the significant reduction in bioburden indicates that cadexomer iodine plays a positive role in providing an environment more conducive to wound closure.