References
Biomodulation induced by fluorescent light energy versus standard of care in venous leg ulcers: a retrospective study
Abstract
Objective:
The recently completed EUREKA study confirmed the efficacy and safety profile of fluorescent light energy (FLE) in treating hard-to-heal wounds. To supplement the EUREKA prospective, observational, uncontrolled trial results, researchers selected one of the EUREKA clinical centres to conduct a retrospective analysis of matching wound care data for 46 venous leg ulcers (VLU) patients who had received standard wound care over a five-year period, compared with 10 EUREKA VLU subjects.
Method:
The study centre selected 46 patients with VLUs based on the matching criteria (wound age and size, patient's age and gender). They compared the healing rates of these matching VLUs with 10 VLU patients treated at the same centre during the EUREKA study.
Results:
The EUREKA patients had larger and significantly older wounds (p<0.05) and significantly more risk factors (p<0.05) than the matching wounds. However, they had better outcomes (EUREKA: 40% versus matching group: 7% for full wound closure by 16 weeks). No wound breakdown was observed at 16 weeks in the EUREKA group, compared with 25% in the matching group. No EUREKA patient developed infections requiring antibiotics, compared with 37% in the matching group. EUREKA wounds had a mean relative wound area regression (RWAR) of 32% at week six and 50% at week 16, compared with −3% at week six and −6% at week 16 for the matching group.
Conclusion:
These findings show that the system based on FLE was well-tolerated and efficacious, with better clinical outcome results compared with the wounds analysed in this retrospective matching study and treated with standard of care alone.
Hard-to-heal wounds present significant challenges to physicians worldwide, impose a significant financial burden on the health-care system and contribute to morbidity and mortality, particularly in ageing populations.1 For populations aged 45–65 years, the incidence of hard-to-heal wounds is estimated at 120 per 100,000 people, and increases to 800 per 100,000 people over 75 years of age.2,3,4 Venous leg ulcers (VLU) are the most common hard-to-heal wounds, accounting for 80% of cases5,6 and recurring in 70% of cases, with a median time-to-ulcer recurrence of 60 days.7,8 VLUs occur when inadequate venous return results in sustained venous hypertension in the lower leg. This chronic condition, the prevalence of which increases with age,9 has numerous consequences involving inappropriate remodelling of venous vessels and dermal inflammatory alterations, leading to superficial tissue breakdown and ulcerations. This latter complication contributes to greatly reduced quality of life (QoL) for affected patients,10 justifying the high need for improving therapeutic strategies, in addition to efficient venous compression.
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