Diabetes, Venous Insufficiency
Conditions
Brief summary
The primary purpose of this study is to evaluate the safety of DermaStream(tm) in the management of chronic wounds. Other goals of this study are to gain feedback from patients and healthcare providers on the ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the efficacy of DermaStream(tm) in chronic wound management.
Detailed description
Until now no expected or unexpected adverse events were occurred
Interventions
DEVICEDermaStream(tm) application and Streaming of Saline
Sponsors
EnzySurge
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diabetic ulcer, OR Venous insufficiency ulcer * Age range: 18-80 years * Wound max. diameter range: 1.5 - 10 centimeters * Wound San Antonio assessment system: grade 1 and 2, stage A and B * Palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries * Ankle-Brachial Index \> 0.7 by Doppler * Wound present for at least 6 weeks * Wound location: foot or calf, at a location where the device can be attached properly * Lack of purulent discharge from the wound.
Exclusion criteria
* Hypoalbuminemia: Albumin \< 2gr/dl * Right-side congestive heart failure with edema of legs: +2 or higher * Renal insufficiency: Cr \> 2 mg/dl * Abnormal liver function: ALT or AST\>300 * Skin disorders adjacent to the wound, unrelated to the pathology of the wound * Non-cooperative patient
Countries
Israel
Outcome results
None listed