Wound Fluid Protease Levels During Use of Novel Wound Dressing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated
ClinicalTrials.gov Identifier:
NCT01567150
First received: March 23, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Venous Stasis Ulcers
Device: Novel Dressing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Wound Fluid Protease Levels During Use of Novel Wound Dressing

Further study details as provided by Hollister Incorporated:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Wound healing (reduction in wound area and incidence of complete closure) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: February 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: novel dressing
Treatment with novel dressing
Device: Novel Dressing
Topical wound dressing
No Intervention: Control
Control is treatment without novel dressing

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01567150

Locations
United States, Arizona
Arizona Heart Hospital
Phoenix, Arizona, United States, 85006
Phoenix Baptist Hospital
Phoenix, Arizona, United States, 85015
United States, Florida
University of Miami, Department of Surgery, Div. of Vascular Surgery
Miami, Florida, United States, 33136
United States, Illinois
Alexian Brothers Medical Center Wound Healing Center
Elk Grove Village, Illinois, United States, 60007
United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10010
United States, Ohio
Circleville Foot & Ankle
Circleville, Ohio, United States, 43113
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Hollister Incorporated
Investigators
Study Director: Ginger Salvadalena, PhD, RN Hollister Incorporated
  More Information

No publications provided

Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT01567150     History of Changes
Other Study ID Numbers: 5064-W
Study First Received: March 23, 2012
Last Updated: May 8, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014