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

March 4, 2009 updated by: Universidad Industrial de Santander

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Santander
      • Bucaramanga, Santander, Colombia
        • Industrial University of Santander UIS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • LLLT
  • Laser therapy
  • Soft laser
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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)
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.
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
Time Frame: The monofilament testing was performed at the beginning and end of the treatment and 60 days thereafter.
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.
Time Frame: The neuroconduction was performed at the beginning and end of the treatment and 60 days thereafter.
The neuroconduction was performed at the beginning and end of the treatment and 60 days thereafter.
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.
The quality of life was applied at the begining and at the end of the treatment.

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: These outcome measures were assessed in the initial examination.
These outcome measures were assessed in the initial examination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

July 18, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

March 5, 2009

Last Update Submitted That Met QC Criteria

March 4, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1102-04-12916
  • 103-2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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