A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of Low-Level Laser Therapy on Venous Leg Ulcers

Abstract

This study aimed to determine the effect of low-level laser therapy (LLLT) on chronic venous leg ulcers (VLUs). A double-blinded prospective randomized controlled trial was conducted to compare incidence of complete wound closure, ulcer size and pain reduction in patients randomized to 24 treatments of placebo or LLLT (635 nm) over 12 weeks. Patients presented with a 6-week history of VLUs ranging in size from 5 to 20 cm. Venous origin was confirmed by Doppler ultrasound and an ankle brachial index of 0.8 or greater. Of 24 patients, 23% of the test group (n = 13) and 18% of placebo group (n = 11) achieved complete wound closure. At 12 weeks, patients in test and placebo groups had a mean surface area reduction of 6.26 cm ( P < .0001) and 6.72 cm ( P < .005), respectively, and a mean pain score decrease of 43.54 points ( P < .0001) and 25.73 points ( P = .002) respectively. Differences between groups was not statistically significant for wound closure ( P = 1.0) or ulcer size ( P = .80). Mean ulcer pain was significantly reduced from initiation of treatment compared with 4 weeks' follow-up after 12 weeks with LLLT ( P < .01). Within the limitations of the study, LLLT may not have early effects as an adjunctive therapy to wound healing of VLUs, but LLLT may have delayed effects on VLU healing and associated pain, which requires further study.

Low-level laser therapy for treatment of venous ulcers evaluated with the Nursing Outcome Classification: study protocol for a randomized controlled trial

“…In both groups, patients will be monitored weekly until complete repair of the ulcer or for a maximum of 16 weeks. The frequency of LLLT application for this protocol was based on previous studies of phototherapy for chronic wounds [ 12 – 16 ]. The duration of treatment was determined based on the average healing period of a chronic wound [ 7 – 12 ].…”

“…The authors of these studies note that more robust research is still needed to enable standardization of parameters and expansion of LLLT to other clinical scenarios, such as venous ulcers. Additional randomized clinical trials are particularly necessary to bridge this knowledge gap [ 12 – 16 ].…”

Effects and Action Mechanism of Low Level Laser Therapy (LLLT): Applications in Periodontology

“…Perhaps the heterogeneity between different conditions and irradiation methods used in different surveys is the reason for which other researches have produced opposite views -that is, that LLLT application offers no benefit to the healing process. For example, some researchers have failed to achieve a statistically significant difference in healing time, in animals or humans [48][49][50].…”

Photobiomodulation using high- or low-level laser irradiations in patients with lumbar disc degenerative changes: disappointing outcomes and remarks

“…In addition, scientists in their clinical trials have repeatedly demonstrated positive anti-inflammatory and analgesic effects in selected disease aspects in both objective terms with the use of modern laboratory equipment – eg, pathomorphological or immunocytochemical analysis of isolated tissues 6 , 7 – and subjective terms, based on the feelings of study participants regarding the symptoms of local inflammation or pain reduction. 8 – 10 …”