A Post Marketing Clinical Study Utilizing DermaStream and Saline in Venous Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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A Post Marketing Clinical Study Utilizing DermaStream and Saline for Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremity

Conditions
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Venous Stasis Ulcers

Intervention / Treatment
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* Device: DermaStream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermastream<br> | Device: DermaStream<br>* Five treatment days. On each day DermaStream application for up to 4 hours of saline streaming.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of DermaStream application | Reduction of slough tissue. | Up to 21 days | 
| Adverse Events | Incidence of investigational product related adverse events | Up to 21 days | 
| Effect of DermaStream application | Increase of granulation tissue | Up to 21 days | 
| Effect of DermaStream application | Pain recording on 1-10 scale | Up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability | Device malfunction reports and device replacements as measures of usability | 1-5 days | 
| Wound size | Decrease in wound size at 2 weeks following last treatment day | Up to 21 days | 
| Quality of Life | Improved Quality of Life at 2 weeks following last treatment day | Up to 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous ulcer Dermastream