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Wound Fluid Protease Levels During Use of Novel Wound Dressing
This study has been completed.
Sponsor:
Hollister Incorporated
Information provided by (Responsible Party):
Hollister Incorporated
ClinicalTrials.gov Identifier:
NCT01567150
First received: March 23, 2012
Last updated: October 4, 2016
Last verified: October 2016
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Venous Stasis Ulcers | Device: Novel Dressing | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Wound Fluid Protease Levels During Use of Novel Wound Dressing |
Resource links provided by NLM:
Further study details as provided by Hollister Incorporated:
Primary Outcome Measures:
- 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:
- Wound Healing [ Time Frame: 12 weeks ]change in wound area mean was calculated for each subject Mean and sd were calculated for each group
| Enrollment: | 35 |
| Study Start Date: | February 2012 |
| Study Completion Date: | January 2014 |
| Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: novel dressing
Treatment with novel dressing
|
Device: Novel Dressing
Topical wound dressing
|
|
No Intervention: Control
Control is treatment without novel 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.
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567150
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567150
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
| Responsible Party: | Hollister Incorporated |
| ClinicalTrials.gov Identifier: | NCT01567150 History of Changes |
| Other Study ID Numbers: |
5064-W |
| Study First Received: | March 23, 2012 |
| Results First Received: | September 22, 2015 |
| Last Updated: | October 4, 2016 |
| Individual Participant Data | |
| 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 |
ClinicalTrials.gov processed this record on June 23, 2017