The purpose of this study was to compare the effects of high voltage pulsed current and low level laser therapy on the healing process of diabetic foot ulcers.
Based in the literature review we concluded that LLLT and HVPC are effective in the healing wound. We did not meet outcomes of previous clinical studies, where compare the effectivity of two physical technologies. For the high prevalence of diabetic foot ulcers, the amputation risk and the consequent impairment and dysfunction in the quality of life, and the associated high costs for this health problem, it is important that new studies that identified effective treatment alternatives for promoting wound closure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
28
The patient´s wounds were treated for 45 minutes with HVPC three times a week for 16 weeks or until their ulcers closed. The active electrode made of aluminum foil was secured directly over the wound, which previously had been loosely packed with sterile gauze soaked with 0.9% saline solution. The dispersive electrode was placed 5 cms proximal to the wound.The electrical stimulator Intelect 340 stim model (Chattanooga Group) produces a twin peaked pulse and was applied with the following parameters: continuous mode, submotor level, 100 Hz pulse frequency and 100microseconds pulse duration. Prior to the beginning the study the electrical stimulator was calibrated with oscilloscope (Tektronix TDS 1002 model).
Wavelenght 633 nm (DMC - Brazil), power 30 mW, continuous, 2 J/cm2 in the edge of the ulcer and 1.5 J/cm2 in the bed, punctual application in direct contact, 3 times a week, 1 every alternate day, for 16 weeks or until the ulcer closed. The laser device was calibrated before each treatment session with a research radiometer (International Light).
Industrial University of Santander UIS
Bucaramanga, Santander Department, Colombia
Characteristics of the wound
Time frame: The wounds were evaluated at the beginning of the study (debridement previous), each two weeks during the intervention, at the finish of treatment and 30 and 60 days after completion of the intervention
Ankle Brachial Index (ABI)
Time frame: The Ankle Braquial Index (ABI) was evaluated at the beginning of the study (debridement previous), each two weeks during the intervention, at the finish of treatment and 30 and 60 days after completion of the intervention.
Sensory testing with the Semmes-Weinstein monofilament
Time frame: The monofilament testing was performed at the beginning and end of the treatment and 60 days thereafter.
Neuroconduction studies with the Nicolet Compass Meridian equipment.
Time frame: The neuroconduction was performed at the beginning and end of the treatment and 60 days thereafter.
Quality of life with the EQ-5D.
Time frame: The quality of life was applied at the begining and at the end of the treatment.
Sociodemographic data like gender and age, were recorded. Additionally clinical history, deformities, alcohol dependence or smoking history, previous and present pharmacologic treatment and corticosteroids were included.
Time frame: These outcome measures were assessed in the initial examination.
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It was based to nursing intervention classification (NIC)46. These interventions were performed by a qualified nurse and included ulcer irrigation with physiological saline, sharp debridement as needed and maintenance of a moist wound environment with appropriate wound dressing. Patients were all educated regarding pressure off loading of the involved foot. All patients received standard wound care seven times a week for 16 weeks or until their ulcers closed.