Feasibility Study of a Novel Device for Chronic Wounds

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility and usability of a new portable and compact wound dressing device for the treatment of small chronic skin wounds.

Detailed Description
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This is an open label study

Official Title
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Feasibility Study of a Novel Device for Chronic Wounds

Conditions
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Ulcer, Wounds and Injuries

Intervention / Treatment
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* Device: SNaP Advanced Wound Care System
* Other: SNaP
* Other: SNaP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:- Venous stasis ulcer or other chronic wound on the lower extremity that is >1.5cm and <10cm at widest point The wound must have at least 2 cm of intact epithelium surrounding it. A wound such as a pressure ulcer or chronic ulcer on a location other than the lower extremity may also be included in the study if it meets the size requirements and a reliable seal can be achieved. Ulcer must not have healed for >14 days under standard treatment. Chronic wound with prior graft placement will be allowed in the study. Patient is >18 years old. Willing and able to sign informed consent. Exclusion Criteria:- Active wound infection. 3+ or greater pitting edema of lower extremity History of malignancy at wound site. However, wounds that are closing by secondary intent after surgical clearance of prior tumor will be allowed in the study. Thick eschar at wound base after debridement. Wound location is not amenable to forming an airtight seal and placement of device. Ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosis lipoidica diabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome. Current smoker (must have quit for >3 weeks) Wound with exposed bone, blood vessels, tendon Significant immunosuppression (as determined by the investigator and sponsor) such as high dose prednisone Fasting blood sugar >200 by study personnel administered bedside fingerstick blood glucose Ankle brachial index less than lower limit of normal (<0.60) as performed and determined by licensed physician (necessary only for patients with lower extremity wounds). Pregnancy Incapable of giving informed consent Inability to comply with study procedures including lack of telephone access for week 8 telephone survey

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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No

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: SNaP application<br>This is an open label pilot study of SNaP Advanced Wound Care System | Device: SNaP Advanced Wound Care System<br>* Application of negative pressure device daily per instructions<br>* Other names: SNaP device (SmartNegative Pressure device);Other: SNaP<br>* Daily use<br>* Other names: SNaP device;Other: SNaP<br>* Daily application per protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Use for Patients | Participants were given instructions to use the SNaP device home. Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again. Numbers responding positively to each question are presented. | Baseline up to 31 days |