None listed
Conditions
Brief summary
Laser therapy has been used to accelerate wound healing for over forty years, but its results are still controversial. The European Pressure Ulcer Advisory Panel (EPUAP), National Pressure Ulcer Advisory Panel (NPUAP) and Pan Pacific Pressure Injury Alliance published an international guideline, “Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline”, in 2014. According to the guideline (content titled “Biophysical agents in pressure ulcer treatment”), several forms of energy have been studied for healing pressure ulcers. These include acoustic, mechanical, and kinetic energy, as well as energy from the electromagnetic spectrum (EMS). Infrared (thermal) radiation and ultraviolet light (invisible light) are all part of the EMS, as is electrical/electromagnetic stimulation. The recommendation for biophysical agents is supported by direct scientific evidence from properly designed and implemented clinical studies on pressure ulcers in humans, providing statistical results that consistently support the recommendation. One of the proposed physical methods in this document is laser irradiation, but the guideline stated that due to current insufficiency of evidence to suport or refute the use of laser therapy in the treatment of pressure ulcers. Laser therapy is not recommended for routine use at this time. The strength of evidence is only classified for C grade (supported by indirect evidence and/or expert opinion). The results of our clinical study (Taradaj et al. “Effect of Laser Irradiation at Different Wavelengths 940, 808, and 658 nm on Pressure Ulcer Healing: Results from a Clinical Study” Evid Based Complement Alternat Med. 2013; 960240: 1-8) showed that the wavelength of the laser beam is extremely important during the wound-healing process (and perhaps this is one reason for the many controversies). In this trial, we found no evidence that justifies using laser therapy at wavelengths of 940 and 808 nm as an adjuvant to the future consensus pressure ulcer treatment. However, in our opinion the wavelength of 658 nm is interesting, and its use yielded in promising clinical results. We cannot agree with a general statement that laser therapy does not accelerate the healing process because the correct parameter settings (wavelength, dose, and method of application) must still be demonstrated in the literature. Future in vitro, animal and clinical studies are necessary, because in literature it is still unknown which processes occur at the cell or tissue level after laser irradiation. The aim of the following study will be collecting the biological material from the wound by biopsy and analysis of angiogenesis, cytometric meausrement of microvasculature density, cell apoptosis, fibroblast activity and collagen concentration, bacteriological and immunology examination.
Interventions
The aim of this clinical research will be to assess the effect of laser irradiation at different wavelengths (940, 808, and 658 nm) on the healing mechanisms in human pressure ulcers.
Intervention:
Patients with pressure ulcers from groups A, B and C will receive laser therapy once daily, 5 times per week for 1 month. The equipment will be a gallium-aluminum-arsenide (GaAlAs) diode laser with an output power of 50 mW and continuous radiation emission at separate wavelengths of 940 nm (group A),
The aim of this clinical research will be to assess the effect of laser irradiation at different wavelengths (940, 808, and 658 nm) on the healing mechanisms in human pressure ulcers. Intervention: Patients with pressure ulcers from groups A, B and C will receive laser therapy once daily, 5 times per week for 1 month. The equipment will be a gallium-aluminum-arsenide (GaAlAs) diode laser with an output power of 50 mW and continuous radiation emission at separate wavelengths of 940 nm (group A), 808 nm (group B) and 658 nm (group C). The spot size will be 0.1 cm2. The laser will be wired to a cone-shaped applicator (scanner). The duration of a single procedure will be relative to the wound size; the therapy will be adjusted to obtain an average dose of 4 J/cm2 (direct dose measured on a surface of the wound). In group D, the placebo group, a laser will be applied in the same manner, but the device will be turned off during the treatment sessions (only the applicator will be turned on to scan ulcers using non-coherent red visible light).
Sponsors
Prof. Jakub Taradaj
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participating subjects will meet the following inclusion criteria: (1) presented with a lower extremity pressure ulcer and (2) provided written informed consent to participate in the study. There will be no restrictions on gender, race, age, or ulcer duration.
Exclusion criteria
Subjects with the following conditions will not be allowed to participate or will be excluded from the study: (1) clinically detectable infection in the ulcer (critical colonization of bacteria, no signs of healing for two weeks, friable granulation tissue, foul odor, increased pain in the ulcer, increased heat in the tissue around the ulcer, an ominous change in the nature of the wound drainage, e.g., new onset of bloody drainage or purulent drainage, or necrotic tissue in the ulcer); (2) use of drugs, such as corticosteroids, that could interfere with the wound-healing process; (3) use of special dressings, such as hydrocolloids, calcium alginate, activated carbon or any type of therapeutic procedure different from that used routinely by all groups in the study; (4) non-attendance to the therapeutic program; (5) pregnancy; (6) ankle-brachial pressure index (ABPI)<0.8; (7) diabetes mellitus; (8) systemic sclerosis; (9) cancer diagnosis; and (10) pareses and paralysis caused by injuries to the central or peripheral nervous system. Patients whose pressure ulcers required surgical intervention will also be excluded from the study.
Outcome results
None listed