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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2013
• Main ID: NCT01376050
• Date of registration: 16/06/2011
• Primary sponsor: Erchonia Corporation
• Public title: Efficacy Study of the Application of Low Level Laser Light to Treat Venous Stasis Ulcers
• Scientific title: A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia(r) ML Scanner (MLS) on Venous Stasis Ulcers
• Date of first enrolment: June 2011
• Target sample size: 80
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01376050
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

France, United States

Contacts

• Name: Jeffery Kenkel, MD

Key inclusion & exclusion criteria

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

- CEAP 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Venous Stasis Ulcer

Intervention(s)

Device: Erchonia ML Scanner (MLS)

Device: Inactive Erchonia ML Scanner (MLS)

Primary Outcome(s)

The number of venous stasis ulcers that achieve complete wound closure within the 12-week treatment period. [Time Frame: baseline and 12 weeks]

Secondary Outcome(s)

Time to complete wound closure for venous stasis ulcers. [Time Frame: baseline and 12 weeks]

Secondary ID(s)

EC_VSU

Source(s) of Monetary Support

Please refer to primary and secondary sponsors