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
  Purpose

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.


Condition Intervention
Diabetic Foot Ulcer
Device: High voltage pulsed current
Device: Low level laser
Other: Standard nursing care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of High Voltage Pulsed Current and Low Level Laser Therapy on Wound Healing in Diabetic Ulcers.

Resource links provided by NLM:


Further study details as provided by Universidad Industrial de Santander:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: March 2004
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HVG
The patients received standard nursing care and HVPC
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
Experimental: LG
These patients received standard nursing care and LLLT
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
Active Comparator: CG
The control group only was treated with standard nursing care
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719251

Locations
Colombia
Industrial University of Santander UIS
Bucaramanga, Santander, Colombia
Sponsors and Collaborators
Universidad Industrial de Santander
Investigators
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
  More Information

Additional Information:
Publications:
Kawalec, JS. Pfennigwerth, TC. Hetherington, VJ. Logan, JS. A review of lasers in healing diabetic ulcers. The foot. 14:68-71, 2004.

Responsible Party: Instituto Colombiano para el desarrollo de la ciencia y la tecnología - COLCIENCIAS, COLCIENCIAS
ClinicalTrials.gov Identifier: NCT00719251     History of Changes
Other Study ID Numbers: 1102-04-12916, 103-2003
Study First Received: July 18, 2008
Last Updated: March 4, 2009
Health Authority: Colombia: Institutional Review Board

Keywords provided by Universidad Industrial de Santander:
Complications of Diabetes Mellitus
Electric stimulation
Low-Level Laser Therapy

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014