Wound Fluid Protease Levels During Use of Novel Wound Dressing



Status:Completed
Conditions:Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:February 2012
End Date:February 2014

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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.

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
We found this trial at
8
sites
Phoenix, Arizona 85006
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Phoenix, AZ
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Dallas, TX
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Circleville, Ohio
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Circleville, OH
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Elk Grove Village, Illinois 60007
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Elk Grove Village, IL
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1 Genesys Pkwy
Grand Blanc, Michigan 48439
(810) 606-5000
Genesys Regional Medical Center Genesys Health System, a member of Ascension Health, is a group...
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Grand Blanc, MI
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Miami, FL
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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New York, NY
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Phoenix, Arizona 85015
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Phoenix, AZ
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