Wound Fluid Protease Levels During Use of Novel Wound Dressing

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Venous Stasis Ulcers	Device: Novel Dressing	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	35 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Wound Fluid Protease Levels During Use of Novel Wound Dressing
Study Start Date :	February 2012
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	January 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: novel dressing; Treatment with novel dressing	Device: Novel Dressing; Topical wound dressing
No Intervention: Control; Control is treatment without novel dressing

Outcome Measures

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Primary Outcome Measures :

1. Matrix Metalloproteinase Level in Wound Fluid [ Time Frame: 8 weeks ]

   Wound fluid will be collected and analyzed at baseline and approximately every 7 days.

   Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups.

Secondary Outcome Measures :

1. Wound Healing [ Time Frame: 12 weeks ]
   change in wound area mean was calculated for each subject Mean and sd were calculated for each group

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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 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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hollister Incorporated
ClinicalTrials.gov Identifier:	NCT01567150 History of Changes
Other Study ID Numbers:	5064-W
First Posted:	March 30, 2012
Results First Posted:	November 25, 2016
Last Update Posted:	November 25, 2016
Last Verified:	October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:

Postphlebitic Syndrome; Postthrombotic Syndrome; Varicose 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