Effects of High Voltage Pulsed Current (HVPC) and Low Level Laser Therapy (LLLT) on Wound Healing in Diabetic Ulcers
Primary Purpose
Diabetic Foot Ulcer
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
High voltage pulsed current
Low level laser
Standard nursing care
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Complications of Diabetes Mellitus, Electric stimulation, Low-Level Laser Therapy
Eligibility 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
Sites / Locations
- Industrial University of Santander UIS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
HVG
LG
CG
Arm Description
The patients received standard nursing care and HVPC
These patients received standard nursing care and LLLT
The control group only was treated with standard nursing care
Outcomes
Primary Outcome Measures
Characteristics of the wound
Ankle Brachial Index (ABI)
Sensory testing with the Semmes-Weinstein monofilament
Neuroconduction studies with the Nicolet Compass Meridian equipment.
Quality of life with the EQ-5D.
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.
Full Information
NCT ID
NCT00719251
First Posted
July 18, 2008
Last Updated
March 4, 2009
Sponsor
Universidad Industrial de Santander
1. Study Identification
Unique Protocol Identification Number
NCT00719251
Brief Title
Effects of High Voltage Pulsed Current (HVPC) and Low Level Laser Therapy (LLLT) on Wound Healing in Diabetic Ulcers
Official Title
Effects of High Voltage Pulsed Current and Low Level Laser Therapy on Wound Healing in Diabetic Ulcers.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidad Industrial de Santander
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Complications of Diabetes Mellitus, Electric stimulation, Low-Level Laser Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HVG
Arm Type
Experimental
Arm Description
The patients received standard nursing care and HVPC
Arm Title
LG
Arm Type
Experimental
Arm Description
These patients received standard nursing care and LLLT
Arm Title
CG
Arm Type
Active Comparator
Arm Description
The control group only was treated with standard nursing care
Intervention Type
Device
Intervention Name(s)
High voltage pulsed current
Other Intervention Name(s)
-electric stimulation, -high voltage stimulation
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Low level laser
Other Intervention Name(s)
Soft laser, Laser therapy, LLLT
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Standard nursing care
Other Intervention Name(s)
Standard wound care, Wound care
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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.
Title
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.
Title
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.
Title
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 Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIA CRISTINA SANDOVAL ORTIZ, MSc in P.T.
Organizational Affiliation
Industrial University of Santander
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ESPERANZA HERRERA VILLABONA, M.Sc. Phys
Organizational Affiliation
Industrial University of Santander
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DIANA MARINA CAMARGO LEMOS, M.Sc. Epid
Organizational Affiliation
Industrial University of Santander
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
RAFAEL CASTELLANOS, Dr.
Organizational Affiliation
Industrial Universtiy of Santander
Official's Role
Study Chair
Facility Information:
Facility Name
Industrial University of Santander UIS
City
Bucaramanga
State/Province
Santander
Country
Colombia
12. IPD Sharing Statement
Citations:
PubMed Identifier
12055444
Citation
Goldman RJ, Brewley BI, Golden MA. Electrotherapy reoxygenates inframalleolar ischemic wounds on diabetic patients: a case series. Adv Skin Wound Care. 2002 May-Jun;15(3):112-20. doi: 10.1097/00129334-200205000-00006.
Results Reference
background
PubMed Identifier
15289715
Citation
Goldman R, Rosen M, Brewley B, Golden M. Electrotherapy promotes healing and microcirculation of infrapopliteal ischemic wounds: a prospective pilot study. Adv Skin Wound Care. 2004 Jul-Aug;17(6):284-94. doi: 10.1097/00129334-200407000-00010.
Results Reference
background
PubMed Identifier
11387573
Citation
Peters EJ, Lavery LA, Armstrong DG, Fleischli JG. Electric stimulation as an adjunct to heal diabetic foot ulcers: a randomized clinical trial. Arch Phys Med Rehabil. 2001 Jun;82(6):721-5. doi: 10.1053/apmr.2001.23780.
Results Reference
background
PubMed Identifier
12495409
Citation
Houghton PE, Kincaid CB, Lovell M, Campbell KE, Keast DH, Woodbury MG, Harris KA. Effect of electrical stimulation on chronic leg ulcer size and appearance. Phys Ther. 2003 Jan;83(1):17-28.
Results Reference
background
PubMed Identifier
15496990
Citation
Hopkins JT, McLoda TA, Seegmiller JG, David Baxter G. Low-Level Laser Therapy Facilitates Superficial Wound Healing in Humans: A Triple-Blind, Sham-Controlled Study. J Athl Train. 2004 Sep;39(3):223-229.
Results Reference
background
PubMed Identifier
9571346
Citation
Schindl A, Schindl M, Schon H, Knobler R, Havelec L, Schindl L. Low-intensity laser irradiation improves skin circulation in patients with diabetic microangiopathy. Diabetes Care. 1998 Apr;21(4):580-4. doi: 10.2337/diacare.21.4.580.
Results Reference
background
PubMed Identifier
15558369
Citation
Demir H, Balay H, Kirnap M. A comparative study of the effects of electrical stimulation and laser treatment on experimental wound healing in rats. J Rehabil Res Dev. 2004 Mar;41(2):147-54. doi: 10.1682/jrrd.2004.02.0147.
Results Reference
background
PubMed Identifier
14677162
Citation
Reddy GK. Comparison of the photostimulatory effects of visible He-Ne and infrared Ga-As lasers on healing impaired diabetic rat wounds. Lasers Surg Med. 2003;33(5):344-51. doi: 10.1002/lsm.10227.
Results Reference
background
PubMed Identifier
15910184
Citation
Maiya GA, Kumar P, Rao L. Effect of low intensity helium-neon (He-Ne) laser irradiation on diabetic wound healing dynamics. Photomed Laser Surg. 2005 Apr;23(2):187-90. doi: 10.1089/pho.2005.23.187.
Results Reference
background
PubMed Identifier
17508840
Citation
Al-Watban FA, Zhang XY, Andres BL. Low-level laser therapy enhances wound healing in diabetic rats: a comparison of different lasers. Photomed Laser Surg. 2007 Apr;25(2):72-7. doi: 10.1089/pho.2006.1094.
Results Reference
background
PubMed Identifier
15047649
Citation
Zinman LH, Ngo M, Ng ET, Nwe KT, Gogov S, Bril V. Low-intensity laser therapy for painful symptoms of diabetic sensorimotor polyneuropathy: a controlled trial. Diabetes Care. 2004 Apr;27(4):921-4. doi: 10.2337/diacare.27.4.921.
Results Reference
background
PubMed Identifier
17508845
Citation
Corazza AV, Jorge J, Kurachi C, Bagnato VS. Photobiomodulation on the angiogenesis of skin wounds in rats using different light sources. Photomed Laser Surg. 2007 Apr;25(2):102-6. doi: 10.1089/pho.2006.2011.
Results Reference
background
PubMed Identifier
17113781
Citation
Silveira PC, Streck EL, Pinho RA. Evaluation of mitochondrial respiratory chain activity in wound healing by low-level laser therapy. J Photochem Photobiol B. 2007 Mar 1;86(3):279-82. doi: 10.1016/j.jphotobiol.2006.10.002. Epub 2006 Nov 20.
Results Reference
background
Citation
Kawalec, JS. Pfennigwerth, TC. Hetherington, VJ. Logan, JS. A review of lasers in healing diabetic ulcers. The foot. 14:68-71, 2004.
Results Reference
result
Links:
URL
http://www.diabetes.org
Description
American Diabetes Association home page
URL
http://www.colciencias.gov.co
Description
Instituto Colombiano para el desarrollo de la ciencia y la tecnología - home page
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Effects of High Voltage Pulsed Current (HVPC) and Low Level Laser Therapy (LLLT) on Wound Healing in Diabetic Ulcers
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