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

Venous Stasis Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129986
• Other study ID #: ENZ-DER-003-US
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: September 2, 2013
• Start date: June 2009
• Est. completion date: November 2011

Study information

• Verified date: June 2011
• Source: EnzySurge
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Stasis Ulcers

Intervention

Device:
• DermaStream
Five treatment days. On each day DermaStream application for up to 4 hours of saline streaming.

Locations

Country	Name	City	State
United States	S.A.L.S.A	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
EnzySurge

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of DermaStream application	Reduction of slough tissue.	Up to 21 days	No
Primary	Adverse Events	Incidence of investigational product related adverse events	Up to 21 days	Yes
Primary	Effect of DermaStream application	Increase of granulation tissue	Up to 21 days	No
Primary	Effect of DermaStream application	Pain recording on 1-10 scale	Up to 21 days	No
Secondary	Usability	Device malfunction reports and device replacements as measures of usability	1-5 days	No
Secondary	Wound size	Decrease in wound size at 2 weeks following last treatment day	Up to 21 days	No
Secondary	Quality of Life	Improved "Quality of Life" at 2 weeks following last treatment day	Up to 21 days	No