Venous Stasis Ulcer
Conditions
Keywords
venous stasis ulcer, leg ulcer
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.
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.
Interventions
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.
DEVICEPlacebo Laser
Placebo Laser has no therapeutic output emitted.
Sponsors
Erchonia Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| Placebo Laser Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output. | 11 |
| Total | 24 |
Baseline characteristics
| Characteristic | Erchonia ML Scanner (MLS) | Placebo Laser | Total |
|---|---|---|---|
| Age, Continuous | 67.92 years STANDARD_DEVIATION 14.78 | 65.80 years STANDARD_DEVIATION 11.17 | 67.00 years STANDARD_DEVIATION 13.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 11 Participants | 24 Participants |
| Region of Enrollment France | 13 participants | 11 participants | 24 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
| Ulcer Size | 10.13 cm² STANDARD_DEVIATION 6.23 | 11.30 cm² STANDARD_DEVIATION 7.55 | 10.53 cm² STANDARD_DEVIATION 6.64 |
| Visual Analog Scale (VAS) Degree of Ulcer Pain Rating | 44.69 units on a scale STANDARD_DEVIATION 23.93 | 30.45 units on a scale STANDARD_DEVIATION 20.04 | 38.17 units on a scale STANDARD_DEVIATION 22.93 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 11 |
| serious Total, serious adverse events | 0 / 13 | 0 / 11 |
Outcome results
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.
Time frame: Baseline and 12 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erchonia ML Scanner (MLS) | Difference in the Proportion of Venous Stasis Ulcers Attaining Complete Wound Closure Between Treatment Groups | 3 participants |
| Placebo Laser | Difference in the Proportion of Venous Stasis Ulcers Attaining Complete Wound Closure Between Treatment Groups | 2 participants |
p-value: >0.05Fisher Exact
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.
Time frame: Baseline and 12 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia ML Scanner (MLS) | Change in Ulcer Size | -6.26 cm² | Standard Deviation 3.66 |
| Placebo Laser | Change in Ulcer Size | -6.72 cm² | Standard Deviation 5.06 |
p-value: >0.05t-test, 2 sided