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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

May 10, 2010
September 2, 2013
June 2009
July 2010   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01129986 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Post Marketing Clinical Study Utilizing DermaStream and Saline in Venous Ulcers
A Post Marketing Clinical Study Utilizing DermaStream and Saline for Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremity

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Stasis Ulcers
Device: DermaStream
Five treatment days. On each day DermaStream application for up to 4 hours of saline streaming.
Experimental: Dermastream
Intervention: Device: DermaStream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 2011
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01129986
ENZ-DER-003-US
Not Provided
EnzySurge
EnzySurge
Not Provided
Principal Investigator: Daniel Ihnat S.A.L.S.A, Tucson Arizona
EnzySurge
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP