Wound Fluid Protease Levels During Use of Novel Wound Dressing
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ClinicalTrials.gov Identifier: NCT01567150 |
Recruitment Status
:
Completed
First Posted
: March 30, 2012
Results First Posted
: November 25, 2016
Last Update Posted
: November 25, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Venous Stasis Ulcers | Device: Novel Dressing | Phase 4 |
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 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567150
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 |
Study Director: | Ginger Salvadalena, PhD, RN | Hollister Incorporated |
Responsible Party: | Hollister Incorporated |
ClinicalTrials.gov Identifier: | NCT01567150 History of Changes |
Other Study ID Numbers: |
5064-W |
First Posted: | March 30, 2012 Key Record Dates |
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 |