Clinical trial NCT01567150: Wound Fluid Protease Levels During Use of Novel Wound Dressing
Official title: Wound Fluid Protease Levels During Use of Novel Wound Dressing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Stasis Ulcers
Lead sponsor: Hollister Incorporated
Sponsor class: INDUSTRY
First posted: 2012-03-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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 Institutional Review Board 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

Primary outcomes:
measure: Matrix Metalloproteinase Level in Wound Fluid
timeFrame: 8 weeks
Secondary outcomes:
measure: Wound Healing
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Hospital
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Baptist Hospital
state: Arizona
city: Miami
country: United States
facility: University of Miami, Department of Surgery, Div. of Vascular Surgery
state: Florida
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center Wound Healing Center
state: Illinois
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Circleville
country: United States
facility: Circleville Foot & Ankle
state: Ohio
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Hollister Incorporated
name: Ginger Salvadalena, PhD, RN
role: STUDY_DIRECTOR
References: