The clinical and cost analysis of laser therapy for healing hard-to-heal leg ulcers: a self-control service evaluation study.

OBJECTIVE: Hard-to-heal (chronic) leg ulcers (LUs) can impair quality of life and, in severe cases, may require amputation. Although there are a few studies on the use of class III laser therapy with LUs, studies using powerful class IV lasers are scarce. The present study uses a class IV therapeutic laser (K-Cube 4; K-Laser; K-Laser USA, LLC, US) which uses four wavelengths (660nm, 800nm, 905nm and 970nm) of diodes in one device to target haemoglobin, water and cytochrome c oxidase simultaneously, with different frequency modulation and high power levels to enhance clinical efficacy and produce short treatment protocols. Patients experience no pain or tissue damage with this procedure, which is non-invasive. The objective was to determine at what rate class IV laser therapy reduces the size of hard-to-heal lower LUs of different aetiologies.

METHOD: This study involved patients with hard-to-heal cutaneous LUs, infected and non-infected, who were non-responsive to standard ulcer treatment for at least six weeks. Medications and dressing materials remained as consistent as possible. Various comorbidities were well controlled for at least four weeks before the trial started. The maximum duration of treatment was 12 therapies, with a four-week post-therapy follow-up. Patients received laser therapy once or twice weekly, to fit in with their dressing change schedule. Ulcer size, wound bed, surrounding tissue condition, pain intensity and overall patient condition were observed. The mean daily percentage area reduction (PAR) with standard deviation was calculated after completing the entire process.

RESULTS: The initial cohort was 20 patients. For the 13 patients who received twice-weekly treatment, the wounds increased in size by an average of 0.5559% per day in the four weeks before starting the class IV laser treatment. After starting laser therapy, the ulcer size decreased with a mean daily PAR of 1.118±1.0078%. For the six patients who received once-weekly treatment, the PAR was 0.329% per day in the four weeks before starting the laser treatment, which increased to a mean daily PAR of 0.604±1.348%. After completing three sessions, one patient declined to participate in therapy. Overall, 17/19 (89.47%) patients received a satisfactory reduction.

CONCLUSION: In this study, class IV laser therapy demonstrated promising outcomes in the treatment of LUs by improving wound healing. However, more large-scale, randomised controlled trials are required to create standardised techniques and fully comprehend the long-term benefits and disadvantages. The cost analysis indicated positive cost-saving results based on the patients within the study. However, these cost-effectiveness estimates are based on very small numbers and so further research is needed with a larger sample.