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:
Universidad Industrial de Santander
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
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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:
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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:
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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:
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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
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:
|
Ulcer Foot Ulcer Diabetic Foot Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer |
Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies |
ClinicalTrials.gov processed this record on May 16, 2013