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

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: High voltage pulsed current; Device: Low level laser; Other: Standard nursing care

• Registration Number: NCT00719251
• Lead Sponsor: Universidad Industrial de Santander

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.

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2006-10
• Study Completion: 2006-12
• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-21
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-04
• Last Update Posted: 2009-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HVG	High voltage pulsed current	The patients received standard nursing care and HVPC
LG	Low level laser	These patients received standard nursing care and LLLT
CG	Standard nursing care	The control group only was treated with standard nursing care

Primary Outcome Measures

Name	Time	Method
Neuroconduction studies with the Nicolet Compass Meridian equipment.	The neuroconduction was performed at the beginning and end of the treatment and 60 days thereafter.
Characteristics of the wound	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
Sensory testing with the Semmes-Weinstein monofilament	The monofilament testing was performed at the beginning and end of the treatment and 60 days thereafter.
Quality of life with the EQ-5D.	The quality of life was applied at the begining and at the end of the treatment.
Ankle Brachial Index (ABI)	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.

Secondary Outcome Measures

Name	Time	Method
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.	These outcome measures were assessed in the initial examination.

Trial Locations

Locations (1)

Industrial University of Santander UIS; 🇨🇴 Bucaramanga, Santander, Colombia