Back to resultsWound Fluid Protease Levels During Use of Novel Wound Dressing
Primary Purpose
Venous Stasis Ulcers
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Novel Dressing
Sponsored by
About this trial
This is an interventional treatment trial for Venous Stasis Ulcers
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
Sites / Locations
- Arizona Heart Hospital
- Phoenix Baptist Hospital
- University of Miami, Department of Surgery, Div. of Vascular Surgery
- Alexian Brothers Medical Center Wound Healing Center
- Genesys Regional Medical Center
- NYU Langone Medical Center
- Circleville Foot & Ankle
- Baylor University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
novel dressing
Control
Arm Description
Treatment with novel dressing
Control is treatment without novel dressing
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Wound Healing
change in wound area mean was calculated for each subject Mean and sd were calculated for each group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01567150
Brief Title
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
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hollister Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Stasis Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
novel dressing
Arm Type
Active Comparator
Arm Description
Treatment with novel dressing
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control is treatment without novel dressing
Intervention Type
Device
Intervention Name(s)
Novel Dressing
Intervention Description
Topical wound dressing
Primary Outcome Measure Information:
Title
Matrix Metalloproteinase Level in Wound Fluid
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Wound Healing
Description
change in wound area mean was calculated for each subject Mean and sd were calculated for each group
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ginger Salvadalena, PhD, RN
Organizational Affiliation
Hollister Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Heart Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Phoenix Baptist Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
University of Miami, Department of Surgery, Div. of Vascular Surgery
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Alexian Brothers Medical Center Wound Healing Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Circleville Foot & Ankle
City
Circleville
State/Province
Ohio
ZIP/Postal Code
43113
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Wound Fluid Protease Levels During Use of Novel Wound Dressing
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