Wound Fluid Protease Levels During Use of Novel Wound Dressing

Phase 4

Completed

• Conditions: Venous Stasis Ulcers
• Interventions: Device: Novel Dressing

• Registration Number: NCT01567150
• Lead Sponsor: Hollister Incorporated

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-30
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2015-09-22
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-04
• Last Update Submitted: 2016-10-04
• Results First Posted: 2016-11-25
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
novel dressing	Novel Dressing	Treatment with novel dressing

Primary Outcome Measures

Name	Time	Method
Matrix Metalloproteinase Level in Wound Fluid	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

Name	Time	Method
Wound Healing	12 weeks	change in wound area mean was calculated for each subject Mean and sd were calculated for each group

Trial Locations

Locations (8)

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

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

Genesys Regional Medical Center; 🇺🇸 Grand Blanc, Michigan, United States

Circleville Foot & Ankle; 🇺🇸 Circleville, Ohio, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States