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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: High voltage pulsed current
* Device: Low level laser
* Other: Standard nursing care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 30 - 75 years Ulcer located on the legs or feet, stage I or II (Wagner Classification System) Diagnosis of diabetes mellitus according to World Health Organization criteria ( treatment with insulin or an oral hypoglycemic agent, two random glucose measurements major than 200 mg/dl, or a fasting glucose major than 140 mg/dl) Exclusion Criteria: Uncontrolled diabetes Ulcer infection Lower limb amputation Orthopedic or neuromuscular pathologic conditions

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HVG<br>The patients received standard nursing care and HVPC | Device: High voltage pulsed current<br>* 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).<br>* Other names: -high voltage stimulation;|
| Experimental: LG<br>These patients received standard nursing care and LLLT | Device: Low level laser<br>* 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).<br>* Other names: LLLT;|
| Active Comparator: CG<br>The control group only was treated with standard nursing care | Other: Standard nursing care<br>* 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.<br>* Other names: Wound care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of the wound |  | 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) |  | 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 |  | 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. |  | The neuroconduction was performed at the beginning and end of the treatment and 60 days thereafter. | 
| Quality of life with the EQ-5D. |  | The quality of life was applied at the begining and at the end of the treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | These outcome measures were assessed in the initial examination. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complications of Diabetes Mellitus, Electric stimulation, Low-Level Laser Therapy