Wound Fluid Protease Levels During Use of Novel Wound Dressing

Completed · Phase 4

Conditions studied: Venous Stasis Ulcers

In brief

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.

Key facts

Study ID

NCT01567150

Run by

Hollister Incorporated

People needed

35

Starts

2012-02-01

Expected to finish

2014-01-01

Last updated by the study team

2016-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Institutional Review Board approved informed consent

You may not qualify if…

• 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

Where it is running

• Arizona Heart Hospital — Phoenix, Arizona, United States
• Phoenix Baptist Hospital — Phoenix, Arizona, United States
• University of Miami, Department of Surgery, Div. of Vascular Surgery — Miami, Florida, United States
• Alexian Brothers Medical Center Wound Healing Center — Elk Grove Village, Illinois, United States
• Genesys Regional Medical Center — Grand Blanc, Michigan, United States
• NYU Langone Medical Center — New York, New York, United States
• Circleville Foot & Ankle — Circleville, Ohio, United States
• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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