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

NCT01376050 | Terminated Results

• 1 other identifier: EC_VSU
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

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.

Conditions

Venous Stasis Ulcer

Keywords

venous stasis ulcer; leg ulcer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Ulcer Size

  Baseline and 12 Weeks

Study Arms (2)

Erchonia ML Scanner (MLS)

ACTIVE COMPARATOR

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)

Placebo Laser

PLACEBO COMPARATOR

Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.

Device: Placebo Laser

Interventions

Erchonia ML Scanner (MLS) DEVICE

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.

Erchonia ML Scanner (MLS)

Placebo Laser DEVICE

Placebo Laser has no therapeutic output emitted.

Placebo Laser

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (2)

Jeffrey Kenkel, MD

Dallas, Texas, 75390, United States

Location

Luc Teot, MD

Montpellier, France

Location

MeSH Terms

Conditions

Varicose Ulcer; Leg Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Consultant
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

615-712-9743

Study Officials

• Jeffery Kenkel, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 20, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 11, 2015
• Results First Posted: December 11, 2015

Record last verified: 2015-11

Locations

FR (1); US (1)