A Post Marketing Clinical Study Utilizing DermaStream and Saline in Venous Ulcers
Not Applicable
Completed
- Conditions
- Venous Stasis Ulcers
- Interventions
- Device: DermaStream
- Registration Number
- NCT01129986
- Lead Sponsor
- EnzySurge
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Group A:
- Must be male or female ≥18 years of age.
- Must be a healthy individual with intact skin
Group B:
- Must be male or female ≥18 years of age
- Must have a venous stasis ulcer between the knee and the ankle (including the lateral and medial malleolus). The ulcer must have the typical appearance of venous leg ulceration and the diagnosis of venous origin.
- Ankle Brachial Pressure Index of >0.8 -<=1.2
- Must have a venous leg ulcer between 3 cm up to 5.6 cm maximum and an ulcer duration of 60 days or greater prior to enrollment in the study
Exclusion Criteria
Group A and Group B:
- Is unable to manage the self-treatment at home
- Is pregnant or is a nursing mother
- Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinent)
- Is < 18 years of age
- With gross morbid obesity (i.e., a Body Mass Index ≥ 50)
- Has a known allergy to any of the drugs and/or dressings that are part of this protocol
- Has previously participated in this study
Group B:
- Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency (e.g., diabetes, malignant ulceration [Marjolin's ulcer], vasculitis, etc.)
- Has evidence of current clinical infection although colonization is not an exclusion criterion (see definition section)
- Suffers from diabetes mellitus with HbA1c ≥ 10%
- Suffers from clinically significant arterial disease
- Has evidence of the ulcer and/or infection extending to the underlying muscle, tendon, or bone
- Has used any investigational drug(s)/device(s) within 30 days preceding screening or the physician or subject anticipates use of any of these treatments during the 2 weeks following start of the treatment portion of the study
- Has used or is anticipated to use any of the prohibited concomitant medications and treatments, as specified in study protocol, section 9.1.
- Suffers from a condition, other than venous insufficiency or venous hypertension which, in the opinion of the Investigator, would compromise the safety of the subject and/or the quality of the data.
- Suffers from a condition, other than venous insufficiency or venous hypertension which, in the opinion of the Investigator, would seriously interfere negatively with the normal wound healing process.
- Has laboratory values at screening outside ± 20% of the institution's normal range for any parameter other than HbA1c
- If laboratory values are outside ± 20% but the investigator deems the subject acceptable for enrollment, the Principal Investigator may approve the inclusion of the subject as long as there is no evidence of any comorbid condition where comorbidity could influence the trialIs using any of the prohibited concomitant medications or treatments.
- Wound surrounding skin not intact or has signs of active dermatitis or infection
- Wound over-bleeds
- Wound is severely ischemic
- Wound is larger than device aperture diameter
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dermastream DermaStream -
- Primary Outcome Measures
Name Time Method Effect of DermaStream application Up to 21 days Pain recording on 1-10 scale
Adverse Events Up to 21 days Incidence of investigational product related adverse events
- Secondary Outcome Measures
Name Time Method Usability 1-5 days Device malfunction reports and device replacements as measures of usability
Wound size Up to 21 days Decrease in wound size at 2 weeks following last treatment day
Quality of Life Up to 21 days Improved "Quality of Life" at 2 weeks following last treatment day
Trial Locations
- Locations (1)
S.A.L.S.A
🇺🇸Tucson, Arizona, United States