Wound Fluid Protease Levels During Use of Novel Wound Dressing

This study is currently recruiting participants.
Verified July 2013 by Hollister Incorporated
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated
ClinicalTrials.gov Identifier:
NCT01567150
First received: March 23, 2012
Last updated: July 17, 2013
Last verified: July 2013
  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 ]

Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567150

Locations
United States, Arizona
Arizona Heart Hospital Recruiting
Phoenix, Arizona, United States, 85006
Contact: Thomas A Osgood, BA, CCRP    602-604-5021    taosgood@abrazohealth.com   
Principal Investigator: Grayson Wheatley, MD         
Phoenix Baptist Hospital Recruiting
Phoenix, Arizona, United States, 85015
Contact: Virginia Ramirez, MPH    602-246-5698    vramirez1@abrazohealth.com   
Sub-Investigator: Laureen Cota, DPM         
United States, Florida
University of Miami, Department of Surgery, Div. of Vascular Surgery Recruiting
Miami, Florida, United States, 33136
Contact: Kay Salinas, MS    305-243-1147    Ksalinas2@med.miami.edu   
Principal Investigator: Goldstein Lee, MD         
United States, Illinois
Alexian Brothers Medical Center Wound Healing Center Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Vanessa Trovela, RN    847-952-7165      
Principal Investigator: S. Khalid Husain, MD         
United States, Michigan
Genesys Regional Medical Center Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Janet M Keeler, RN, CCRC    810-606-7714    jkeeler@genesys.org   
Principal Investigator: David T Taylor, DPM, FACFAS         
United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10010
Contact: Carla Alamia, BS, CCRC    212-263-4355    carla.alamia@nyumc.org   
Principal Investigator: Ernest S Chiu, MD, FACS         
United States, Ohio
Circleville Foot & Ankle Completed
Circleville, Ohio, United States, 43113
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Max A Castillo    214-820-9907    maxA.Castillo@baylorhealth.edu   
Principal Investigator: Andrew Applewhite, MD         
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: July 17, 2013
Health Authority: United States: Institutional Review Board

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 April 16, 2014