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Completed

NCT Number: NCT00719251

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

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Industrial University of Santander UIS

Bucaramanga, Santander Department, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High voltage pulsed current

Device

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).

Other names: -electric stimulation, -high voltage stimulation

Low level laser

Device

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 names: Soft laser, Laser therapy, LLLT

Standard Nursing Care

Other

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.

Other names: Standard wound care, Wound care

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universidad Industrial de Santander

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jul 21, 2008
Registry last updated
Mar 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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