|dc.description.abstract||Venous leg ulcers (VLUs) are the most common ulcers of the lower limb accounting for 70% of all ulcerations of that kind. Reports suggest that with the current prevalence of chronic venous leg ulcers (CVLUs) of between 0.1% and 0.3% almost 1% of the population in the UK will suffer from VLUs at some stage in their lives (Agale, 2013). Currently the cost of VLU treatment by the NHS is estimated to range between £168 million and £198 million each year with 100,000 new cases of VLUs being reported annually (WELSH WOUND NETWORK.2017).
VLUs are open wounds which can be reoccurring and can remain active for many weeks or even years. They have the potential to cause severe secondary complications such as squamous cell carcinoma, osteomyelitis or cellulites (Reich-Schupke et al. 2015). Many affected patients present with copious exudate, swelling and inflammation which lead to profound pain as well as psychological problems such as anxiety, depression, reduced sleep and a general sense of discomfort (Edwards et al. 2014).
Recently, low level laser therapy (LLLT) has gained increased attention in treatment of VLUs, a phenomenon particularly evident from more than 400 double blinded randomised placebo control human trials supported by over 4,000 scientific research studies investigating the underlying mechanisms that present a local and systemic response to LLLT (Perlin, 2015). Low level laser therapy is thought to be beneficial in the healing of VLUs as it is believed to modulate Matrix Metalloproteinase levels (MMP) and reduce Reactive Oxygen Species (ROS), factors typically increased in CVLU patients. In addition, LLLT can lead to reduction of infection and pain associated with CVLUs.
There are significant variations in the operational parameters of the lasers resulting in different outputs and these include the wavelength, power density, power output and fluence. If the incorrect parameters are chosen, which has been documented by a number of authors in the past, little or no effectiveness of the treatment or even tissue damage can be reported. Therefore it is imperative for positive results to choose the correct values of the critical factors.
A thorough literature review on the effects of LLLT on wound healing and venous leg ulcers has been completed as part of this research proposal. Based on the literature review a number of parameters have been selected and are believed to be the most suitable for the application in the therapy of VLUs.
The proposed 11 month long study is designed as a double blind randomised control trial with 44 participants recruited from wound clinics in cork. The participants will be appropriately randomised to receive LLLT or light emitting diode (LED) placebo; a conventional treatment of a hydrocolloid dressing and four layer compression bandaging will be applied after each treatment session regardless of the treatment group. The company supplying the laser machine for the study has assured that no difference in both the treatment and the placebo will be evident, making the distinction between the two treatment types effectively impossible even to a trained personnel. The obtained empirical data will be analysed by a qualified statistician and presented graphically to facilitate result interpretation.||