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

Venous Stasis Ulcer Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia ML Scanner (MLS) on Venous Stasis Ulcers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01376050
• Other study ID #: EC_VSU
• Status: Terminated
• Phase: N/A
• First received: June 16, 2011
• Last updated: November 7, 2015
• Start date: June 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2015
• Source: Erchonia Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Stasis Ulcer

Intervention

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 Laser
Placebo Laser has no therapeutic output emitted.

Locations

Country	Name	City	State
France	Luc Teot, MD	Montpellier
United States	Jeffrey Kenkel, MD	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Erchonia Corporation

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the Proportion of Venous Stasis Ulcers Attaining Complete Wound Closure Between Treatment Groups	'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.	Baseline and 12 Weeks	No
Secondary	Change in Ulcer Size	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.	Baseline and 12 Weeks	No