NCT00719251

Effects of High Voltage Pulsed Current (HVPC) and Low Level Laser Therapy (LLLT) on Wound Healing in Diabetic Ulcers

Effects of High Voltage Pulsed Current and Low Level Laser Therapy on Wound Healing in Diabetic Ulcers.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Universidad Industrial de Santander · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	High voltage pulsed current	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).
DEVICE	Low level laser	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).
OTHER	Standard nursing care	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.

Timeline

• Start date: 2004-03-01
• Primary completion: 2006-10-01
• Completion: 2006-12-01
• First posted: 2008-07-21
• Last updated: 2009-03-05

Locations

1 site across 1 country: Colombia