An open-label, prospective, controlled, two-step approach, post-marketing clinical study, applying DermaStream with saline streaming, in conjunction with a sustained multi-compression wrap, on healthy individuals and on patients with a venous stasis ulcer of the lower extremity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Five treatment days. On each day DermaStream application for up to 4 hours of saline streaming.
S.A.L.S.A
Tucson, Arizona, United States
Effect of DermaStream application
Reduction of slough tissue.
Time frame: Up to 21 days
Adverse Events
Incidence of investigational product related adverse events
Time frame: Up to 21 days
Effect of DermaStream application
Increase of granulation tissue
Time frame: Up to 21 days
Effect of DermaStream application
Pain recording on 1-10 scale
Time frame: Up to 21 days
Usability
Device malfunction reports and device replacements as measures of usability
Time frame: 1-5 days
Wound size
Decrease in wound size at 2 weeks following last treatment day
Time frame: Up to 21 days
Quality of Life
Improved "Quality of Life" at 2 weeks following last treatment day
Time frame: Up to 21 days
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