Citation of the full article:
Kajagar BM., Godhi AS., Archit P. and Khatri S., 2012. Efficacy of low level laser therapy (LLLT) on wound healing in patients with chronic diabetic foot ulcers—A Randomised Control Trial. Indian J Surg 74(5):359–363
Although, various researches in published literatures justified the fact that diabetic foot ulcers (DFU) are resistance to conventional therapies, the advent of low level laser therapy (LLLT) has shown promising results in the treatment and management of the condition. This randomized controlled trial involving 68 diabetics with DFU (Meggitt Wagner grade I) showed the mean ukcer area to reduce significantly by 40.24±6.30% after a combination of LLLT and conventional therapies for 15 days thus proving to be effective in stimulating the healing process in DFUs. There was no significant difference in socio – demographics and biochemical characteristics between patients in the study and control groups to have confounded the results of the study.
As stated above, the purpose of the study was to investigate the efficacy of LLLT in the healing dynamics of DFUs and to do this, the study sought to determine the mean percentage in wound area in both the study and the control groups before and after the intervention. The percentage wound area was found to significantly reduce in the study group despite no difference in socio-demographic and biochemical characteristics of the patients. However, it is still unknown how LLLT will affect the healing dynamics in diabetics with DFU higher than grade I on the Meggitt-Wagner categorisation scale.
A total of 68 type 2 diabetes mellitus patients with Meggitt Wagner grade I DFU of duration of at least 4 weeks were recruited for the study and randomised into two groups (the study and control groups, each consisting of 34 patients). Preliminary biomedical tests such as haemamogram, kidney and liver function tests, fasting blood sugar, glycosylated haemoglobin tests etc. were carried out on consenting patients before recruitment in order to determine their eligibility to participate in the study. Patients who were deemed eligible were recruited while those that were not were excluded from the study. Ulcer size was also measured before and after the study in both study and control groups. Insulin/Oral hypoglycaemic agents was used to maintain good glycaemic control and systemic antibiotic (based on culture sensitivity report) to control infections before the commencement of LLLT treatment in the study group. In this group, the ulcer floor and edges were irradiated at 2-4J/cm2 (depending on the size of the ulcer area) at 60mW, 5KHz daily for the 15 days of treatment.
Although male to female ratio was 3:1, there was no significant difference in risk factors and demographic characteristics of patients that took part in the study. A comparison of the fasting blood sugar and glycosylated haemoglobin levels between patients in the study and control groups shows no significant difference but duration of intake of oral hypoglycaemic agents was 10years among controls compared to 5years among participants in the study group. The mean reduction in ulcer size after 15 treatment days was 322.44±85.84mm2 and 1043.20±266.62mm2 in the control and the study groups respectively.
Assessing this trial critically shows that the research was carefully conducted. However, there are no scientific researches without pitfalls and limitations and for the sake of future researches; these limitations will be examined in this write-up. First, the fact that this study was carried out among Indians only means generalizing the results may be too soon. Also, how the sample size was determined was not discussed in the study and the sampling procedure was more or less purposive. While this may not be a problem that can affect the outcome of the study, it means the sample may not be representative of the general population so generalisation of findings should be done with great caution. Moreover, sugar level was closely monitored among patients in the study group but it is unclear if same was done in the control group. Uncontrolled glycaemic levels might have worsened the conditions of those in the control group and affected the healing of their wounds adversely.
While the findings from this trial may be a good news for diabetics with DFU in grade I of the Meggitt-Wagner’s scale (because all the study participants had DFU in Meggitt-Wagner grade I), it is yet to be determined how this therapy will influence the healing process in deeper and more severe cases of DFU. This may be an important area of future researches as LLLT is still evolving with promising results in various areas of health management.
In conclusion, this trial is an important foundation on which future researches in this area can build upon as it offers a chance of reprieve for those suffering from DFU even as the prevalence of diabetes continue to rise globally. However, it is recommended that future researches should be done to determine the efficacy of LLLT as an alternate therapy rather than an adjunct to conventional therapy.