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Wound Fluid Protease Levels During Use of Novel Wound Dressing

This study is currently recruiting participants.
Verified February 2013 by Hollister Incorporated
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated
ClinicalTrials.gov Identifier:
NCT01567150
First received: March 23, 2012
Last updated: February 13, 2013
Last verified: February 2013
History of Changes

March 23, 2012
February 13, 2013
February 2012
August 2013   (final data collection date for primary outcome measure)
MMP level in wound fluid [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Wound fluid will be collected and analyzed at baseline and approximately every 7 days
Same as current
Complete list of historical versions of study NCT01567150 on ClinicalTrials.gov Archive Site
Wound healing (reduction in wound area and incidence of complete closure) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Wound Fluid Protease Levels During Use of Novel Wound Dressing
Wound Fluid Protease Levels During Use of Novel Wound Dressing

This study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing. The investigators will collect wound fluid for biochemical analysis, and they will measure the wound healing that occurs with and without the new dressing.

Abnormal wound healing is characterized by prolonged inflammation and excess degradation of the extracellular matrix through the activity of proteinases and other enzymes. Wound fluids can provide biochemical information about the healing status of chronic wounds and the effects of wound treatments. In this study the investigators will obtain samples of wound fluid and measure healing in wounds randomized to receive the novel dressing or a control. The findings will be compared between the two groups.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Stasis Ulcers
Device: Novel Dressing
Topical wound dressing
  • Active Comparator: novel dressing
    Treatment with novel dressing
    Intervention: Device: Novel Dressing
  • No Intervention: Control
    Control is treatment without novel dressing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
October 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of venous insufficiency
  • One or more partial or full-thickness venous leg ulcers 5-24 sq. cm in size without evidence of clinical infection
  • Ankle/brachial index 0.8 and above
  • Duration of wound up to one year
  • Able to return to wound clinic for weekly evaluations
  • Has signed IRB approved informed consent

Exclusion Criteria:

  • Exposed bone or tendon or necrotic wound base
  • Signs or symptoms of cellulitis or osteomyelitis at the target ulcer
  • Allergy to a component of the novel dressing or compression wrap
  • Third degree burn
  • Vasculitis, severe rheumatoid arthritis or other collagen vascular disease
  • Receiving antibiotics
  • Pregnant or lactating
Both
18 Years and older
No
Not Provided
United States
 
NCT01567150
5064-W
No
Hollister Incorporated
Hollister Incorporated
Not Provided
Study Director: Ginger Salvadalena, PhD, RN Hollister Incorporated
Hollister Incorporated
February 2013

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