Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management

EnzySurge

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetes; Venous Insufficiency

Treatments: Device: DermaStream(tm) application and Streaming of Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00310752

DS-1

Details and patient eligibility

About

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.

Full description

Until now no expected or unexpected adverse events were occurred

Enrollment: 11 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)