Clinical trial NCT00719251: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Complications of Diabetes Mellitus
Electric stimulation
Low-Level Laser Therapy
Lead sponsor: Universidad Industrial de Santander
Sponsor class: OTHER
First posted: 2008-07-21
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Characteristics of the wound
timeFrame: 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
measure: Ankle Brachial Index (ABI)
timeFrame: 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.
measure: Sensory testing with the Semmes-Weinstein monofilament
timeFrame: The monofilament testing was performed at the beginning and end of the treatment and 60 days thereafter.
measure: Neuroconduction studies with the Nicolet Compass Meridian equipment.
timeFrame: The neuroconduction was performed at the beginning and end of the treatment and 60 days thereafter.
measure: Quality of life with the EQ-5D.
timeFrame: The quality of life was applied at the begining and at the end of the treatment.
Secondary outcomes:
measure: 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.
timeFrame: These outcome measures were assessed in the initial examination.
Other outcomes:
Locations:
city: Bucaramanga
country: Colombia
facility: Industrial University of Santander UIS
state: Santander
Study officials:
affiliation: Industrial University of Santander
name: MARIA CRISTINA SANDOVAL ORTIZ, MSc in P.T.
role: PRINCIPAL_INVESTIGATOR
affiliation: Industrial University of Santander
name: ESPERANZA HERRERA VILLABONA, M.Sc. Phys
role: PRINCIPAL_INVESTIGATOR
affiliation: Industrial University of Santander
name: DIANA MARINA CAMARGO LEMOS, M.Sc. Epid
role: STUDY_CHAIR
affiliation: Industrial Universtiy of Santander
name: RAFAEL CASTELLANOS, Dr.
role: STUDY_CHAIR
References:
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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.
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.
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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.
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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.
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.
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.
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.
citation: Kawalec, JS. Pfennigwerth, TC. Hetherington, VJ. Logan, JS. A review of lasers in healing diabetic ulcers. The foot. 14:68-71, 2004.