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

This study has been completed.
Sponsor:
Information provided by:
Universidad Industrial de Santander
ClinicalTrials.gov Identifier:
NCT00719251
First received: July 18, 2008
Last updated: March 4, 2009
Last verified: March 2009

July 18, 2008
March 4, 2009
March 2004
October 2006   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00719251 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Foot Ulcer
  • 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).
    Other Names:
    • -electric stimulation
    • -high voltage stimulation
  • 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 Names:
    • Soft laser
    • Laser therapy
    • LLLT
  • 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.
    Other Names:
    • Standard wound care
    • Wound care
  • Experimental: HVG
    The patients received standard nursing care and HVPC
    Intervention: Device: High voltage pulsed current
  • Experimental: LG
    These patients received standard nursing care and LLLT
    Intervention: Device: Low level laser
  • Active Comparator: CG
    The control group only was treated with standard nursing care
    Intervention: Other: Standard nursing care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2006
October 2006   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT00719251
1102-04-12916, 103-2003
Yes
Instituto Colombiano para el desarrollo de la ciencia y la tecnología - COLCIENCIAS, COLCIENCIAS
Universidad Industrial de Santander
Not Provided
Principal Investigator: MARIA CRISTINA SANDOVAL ORTIZ, MSc in P.T. Industrial University of Santander
Principal Investigator: ESPERANZA HERRERA VILLABONA, M.Sc. Phys Industrial University of Santander
Study Chair: DIANA MARINA CAMARGO LEMOS, M.Sc. Epid Industrial University of Santander
Study Chair: RAFAEL CASTELLANOS, Dr. Industrial Universtiy of Santander
Universidad Industrial de Santander
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP