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

NCT01129986 | Completed

• 1 other identifier: ENZ-DER-003-US
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Stasis Ulcers

Keywords

venous ulcer Dermastream

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Usability

  1-5 days

• Wound size

  Up to 21 days

• Quality of Life

  Up to 21 days

Study Arms (1)

Dermastream

EXPERIMENTAL

Device: DermaStream

Interventions

DermaStream DEVICE

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

Dermastream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)
• 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.

Sponsors & Collaborators

• EnzySurge: lead

Study Sites (1)

S.A.L.S.A

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Daniel Ihnat

  S.A.L.S.A, Tucson Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 25, 2010
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: November 1, 2011
• Last Updated: September 4, 2013

Record last verified: 2011-06

Locations

US (1)