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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EnzySurge
ClinicalTrials.gov Identifier:
NCT01129986
First received: May 10, 2010
Last updated: September 2, 2013
Last verified: June 2011
  Purpose

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.


Condition Intervention
Venous Stasis Ulcers
Device: DermaStream

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Post Marketing Clinical Study Utilizing DermaStream and Saline for Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremity

Further study details as provided by EnzySurge:

Primary Outcome Measures:
  • Effect of DermaStream application [ Time Frame: Up to 21 days ] [ Designated as safety issue: No ]
    Reduction of slough tissue.

  • Adverse Events [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]
    Incidence of investigational product related adverse events

  • Effect of DermaStream application [ Time Frame: Up to 21 days ] [ Designated as safety issue: No ]
    Increase of granulation tissue

  • Effect of DermaStream application [ Time Frame: Up to 21 days ] [ Designated as safety issue: No ]
    Pain recording on 1-10 scale


Secondary Outcome Measures:
  • Usability [ Time Frame: 1-5 days ] [ Designated as safety issue: No ]
    Device malfunction reports and device replacements as measures of usability

  • Wound size [ Time Frame: Up to 21 days ] [ Designated as safety issue: No ]
    Decrease in wound size at 2 weeks following last treatment day

  • Quality of Life [ Time Frame: Up to 21 days ] [ Designated as safety issue: No ]
    Improved "Quality of Life" at 2 weeks following last treatment day


Enrollment: 15
Study Start Date: June 2009
Study Completion Date: November 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dermastream Device: DermaStream
Five treatment days. On each day DermaStream application for up to 4 hours of saline streaming.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129986

Locations
United States, Arizona
S.A.L.S.A
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
EnzySurge
Investigators
Principal Investigator: Daniel Ihnat S.A.L.S.A, Tucson Arizona
  More Information

No publications provided

Responsible Party: EnzySurge
ClinicalTrials.gov Identifier: NCT01129986     History of Changes
Other Study ID Numbers: ENZ-DER-003-US
Study First Received: May 10, 2010
Last Updated: September 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by EnzySurge:
venous ulcer Dermastream

Additional relevant MeSH terms:
Postphlebitic Syndrome
Postthrombotic Syndrome
Varicose Ulcer
Ulcer
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014