Wound Fluid Protease Levels During Use of Novel Wound Dressing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Wound Fluid Protease Levels During Use of Novel Wound Dressing

Conditions
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Venous Stasis Ulcers

Intervention / Treatment
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* Device: Novel Dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: novel dressing<br>Treatment with novel dressing | Device: Novel Dressing<br>* Topical wound dressing<br>|
| No Intervention: Control<br>Control is treatment without novel dressing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Matrix Metalloproteinase Level in Wound Fluid | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing | change in wound area mean was calculated for each subject Mean and sd were calculated for each group | 12 weeks |