Efficacy Study of the Application of Low Level Laser Light to Treat Venous Stasis Ulcers

• Sponsor: Erchonia Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01376050
• Collaborator: (none)
• Enrollment: 24
• Locations: 2
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 12
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether low level laser light therapy is effective as an adjunctive therapy to the healing of venous stasis leg ulcers.

Condition or Disease	Intervention/Treatment	Phase
Venous Stasis Ulcer	Device: Erchonia ML Scanner (MLS); Device: Placebo Laser	N/A

Detailed Description

A chronic venous stasis leg ulcer is a wound below the knee that fails to heal within 6 weeks. Venous stasis ulcers account for 80% to 90% of all leg and foot ulcers, affecting an estimated 500,000-600,000 people in the United States every year. Venous stasis ulcers account for the loss of 2 million working days and incur treatment costs around $3 billion dollars annually in the United States. Standard of care for venous stasis ulcers includes compression of the affected leg together with daily dressing changes to minimize swelling; debridement of the ulcer to remove dead tissue and bacteria; and daily wound Care dressing to keep the wound clean. Venous stasis ulcers typically have very lengthy and poor healing rates, with up to 50% remaining open and unhealed for 9 months or longer. Many patients suffer pain and sleep and mobility problems, impairing quality of life. Recurrence rates for venous stasis ulcers is very high, with about one third of treated individuals experiencing 4 or more episodes of ulceration.

Low level laser light therapy (LLLT), with its proven tissue healing acceleration properties has recently gained attention as a simple, non-invasive alternative adjunctive therapy to assist in both wound closure and accelerated time to wound closure. Numerous histological trials have exhibited laser therapy's capacity to upregulate essential wound-healing factors such as vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), oxygen concentration, fibroblast proliferation, collagen synthesis, re-epithelialization, and tissue granulation. Clinically, the application of laser therapy has demonstrated promise, accelerating the rate of wound healing and tissue contracture.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia ML Scanner (MLS) on Venous Stasis Ulcers
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Erchonia ML Scanner (MLS) Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.	Device: Erchonia ML Scanner (MLS); Erchonia MLS comprises three 17.5 mW 635 nm diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
Placebo Comparator: Placebo Laser Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.	Device: Placebo Laser; Placebo Laser has no therapeutic output emitted.

Outcome Measures

Primary Outcome Measures

1. Difference in the Proportion of Venous Stasis Ulcers Attaining Complete Wound Closure Between Treatment Groups [Baseline and 12 Weeks]

   'Complete wound closure' is defined as skin re-epithelialization without drainage or dressing requirements confirmed across a consecutive two-week evaluation period. Efficacy success was defined as a statistically significant greater proportion of venous stasis ulcers in the test procedure group achieving complete wound closure compared with the proportion of venous stasis ulcers in the placebo procedure group achieving complete wound closure.

Secondary Outcome Measures

1. Change in Ulcer Size [Baseline and 12 Weeks]

   The study ulcer was digitally photographed, and the ulcer size/area calculated in centimeters squared (cm²) using the Aranz Medical SilhouetteMobile™ System, a portable handheld computer device with custom camera and software that enables capturing of a wound image at the point of care. The change in ulcer size from baseline to study endpoint (12 weeks) was calculated. A decrease in ulcer size indicates an improvement in the ulcer status and is positive for study success. An increase in ulcer size indicates a worsening of the ulcer status and is negative for study success.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least one venous stasis ulcer, diagnosed according to a differential diagnosis methodology that satisfies both criteria supportive of the ulcer's venous origin and criteria that eliminates the ulcer as being indicative of non-venous origin. Diagnostic criteria to evaluate satisfaction of criteria that is supportive of venous origin of the ulcer will involve an evaluation of medical history and wound history variables; physical examination of the affected leg and ulcer site; and objective testing

• Resting Ankle Brachial Pressure Index (ABPI) of 0.8 or greater

• Venous Doppler ultrasound shows reflux in the suspect vein

• Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification System Class 6

• Ulcer measures 5 to 20cm², inclusive, according to standardized computerized planimetry evaluation

• presenting venous leg ulcer has been present for 6 continuous weeks or longer

• Subject agrees to not partake in any other form of treatment for the ulcer throughout study participation, other than the standard of care treatment provided by the investigator as part of the study protocol

Exclusion Criteria:

• Satisfaction of any exclusive diagnostic criteria that is considered indicative of an ulcer being of non-venous origin (e.g. arterial or mixed origin), or as having a non-venous component. This evaluation will include consideration of medical history and wound history variables; examination of the affected leg and ulcer site; and objective tests and measurements

• Resting Ankle Brachial Pressure Index (ABPI) of less than 0.8

• Doppler ultrasound that shows absence of reflux in the suspect vein

• Fasting blood glucose (blood sugar) level of greater than 140 mg/dl that is indicative of current or potential diabetes

• Subject presents with factors that may significantly impede or delay the healing of chronic non-healing wounds, including known diabetes or other disordered glucose metabolic disease; malnutrition; collagen diseases such as Ehlers-Danlos syndrome; history of systematic glucocorticosteroid therapy; history of exogenous glucocorticosteroid therapy; and chemotherapeutic (antineoplastic) drug use

• Ulcer has significant bacterial infection, confirmed by a positive swab culture utilizing Levine's technique

• Ulcer has been present for less than 6 continuous weeks

• Ulcer is of CEAP Class 0 through 5, inclusive

• Ulcer measures less than 5cm² or greater than 20cm², according to standardized computerized planimetry evaluation

• Exposed bone tendon or fascia

• General skin disorder such as psoriasis or penicilitis

• Immunosuppressive disorder

• Hypercoagulable state

• Prior deep vein thrombosis

• Cellulites during the one-year period prior to study participation in

• Vasculitis or collagen vascular disease

• History of prior venous surgery

• Any concomitant illness(es) or medical condition(s) that would render the subject inappropriate for the study (i.e., renal failure, liver disease, connective tissue disorders, etc.)

• Active or recurrent cancer or currently receiving chemotherapy or radiation therapy

• Subject is taking a regimen of any medication(s) that may affect wound healing, including corticosteroid, chemotherapeutic and non-steroidal anti-inflammatory (NSAID) medications

• Developmental disability/significant psychological disorder that could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years

• Females currently pregnant or lactating or intending to attempt to become pregnant during the course of intended study participation

• Involvement in litigation/receiving disability benefits related to venous stasis ulcer(s).

• Other research participation in the 30 days prior to study qualification evaluation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jeffrey Kenkel, MD	Dallas	Texas	United States	75390
2	Luc Teot, MD	Montpellier		France

Sponsors and Collaborators

• Erchonia Corporation

Investigators

• Principal Investigator: Jeffery Kenkel, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erchonia Corporation
• ClinicalTrials.gov Identifier: NCT01376050
• Other Study ID Numbers: EC_VSU
• First Posted: Jun 20, 2011
• Last Update Posted: Dec 11, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Erchonia Corporation: venous stasis ulcer; leg ulcer
• Additional relevant MeSH terms: Varicose Ulcer; Ulcer

Study Results

Participant Flow

Arm/Group Title	Erchonia ML Scanner (MLS)	Placebo Laser
Arm/Group Description	Erchonia ML Scanner (MLS) comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light-emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.	Placebo Laser has the same appearance and function as the Erchonia MLS but not does emit any therapeutic output.
Period Title: Overall Study
STARTED	13	11
COMPLETED	13	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Erchonia ML Scanner (MLS)	Placebo Laser	Total
Arm/Group Description	Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.	Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.	Total of all reporting groups
Overall Participants	13	11	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.92 (14.78)	65.80 (11.17)	67.00 (13.09)
Sex: Female, Male (Count of Participants)
Female	7 53.8%	6 54.5%	13 54.2%
Male	6 46.2%	5 45.5%	11 45.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	13 100%	11 100%	24 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
France	13 100%	11 100%	24 100%
Ulcer Size (cm²) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm²]	10.13 (6.23)	11.30 (7.55)	10.53 (6.64)
Visual Analog Scale (VAS) Degree of Ulcer Pain Rating (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	44.69 (23.93)	30.45 (20.04)	38.17 (22.93)

Outcome Measures

1. Primary Outcome

Title	Difference in the Proportion of Venous Stasis Ulcers Attaining Complete Wound Closure Between Treatment Groups
Description	'Complete wound closure' is defined as skin re-epithelialization without drainage or dressing requirements confirmed across a consecutive two-week evaluation period. Efficacy success was defined as a statistically significant greater proportion of venous stasis ulcers in the test procedure group achieving complete wound closure compared with the proportion of venous stasis ulcers in the placebo procedure group achieving complete wound closure.
Time Frame	Baseline and 12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erchonia ML Scanner (MLS)	Placebo Laser
Arm/Group Description	Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.	Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
Measure Participants	13	11
Number [participants]	3 23.1%	2 18.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erchonia ML Scanner (MLS), Placebo Laser
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Change in Ulcer Size
Description	The study ulcer was digitally photographed, and the ulcer size/area calculated in centimeters squared (cm²) using the Aranz Medical SilhouetteMobile™ System, a portable handheld computer device with custom camera and software that enables capturing of a wound image at the point of care. The change in ulcer size from baseline to study endpoint (12 weeks) was calculated. A decrease in ulcer size indicates an improvement in the ulcer status and is positive for study success. An increase in ulcer size indicates a worsening of the ulcer status and is negative for study success.
Time Frame	Baseline and 12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erchonia ML Scanner (MLS)	Placebo Laser
Arm/Group Description	Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.	Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
Measure Participants	13	11
Mean (Standard Deviation) [cm²]	-6.26 (3.66)	-6.72 (5.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erchonia ML Scanner (MLS), Placebo Laser
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	13 Weeks
Arm/Group Title	Erchonia ML Scanner (MLS)		Placebo Laser
Arm/Group Description	Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.		Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
All Cause Mortality
	Erchonia ML Scanner (MLS)		Placebo Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Erchonia ML Scanner (MLS)		Placebo Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Erchonia ML Scanner (MLS)		Placebo Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.