Wound Fluid Protease Levels During Use of Novel Wound Dressing
This study is currently recruiting participants.
Verified February 2013 by Hollister Incorporated
Sponsor:
Hollister Incorporated
Information provided by (Responsible Party):
Hollister Incorporated
ClinicalTrials.gov Identifier:
NCT01567150
First received: March 23, 2012
Last updated: February 13, 2013
Last verified: February 2013
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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 |
Further study details as provided by Hollister Incorporated:
Primary Outcome Measures:
- MMP level in wound fluid [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Wound fluid will be collected and analyzed at baseline and approximately every 7 days
Secondary Outcome Measures:
- Wound healing (reduction in wound area and incidence of complete closure) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | August 2013 (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 |
| Genders Eligible for Study: | Both |
| 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 IRB 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567150
Locations
| United States, Arizona | |
| Arizona Heart Hospital | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Contact: Angela Allender, MA 602-908-9029 amallend@abrazohealth.com | |
| Principal Investigator: Grayson Wheatley, MD | |
| United States, Florida | |
| University of Miami, Department of Surgery, Div. of Vascular Surgery | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Kay Salinas, MS 305-243-1147 Ksalinas2@med.miami.edu | |
| Principal Investigator: Goldstein Lee, MD | |
| United States, Illinois | |
| Alexian Brothers Medical Center Wound Healing Center | Recruiting |
| Elk Grove Village, Illinois, United States, 60007 | |
| Contact: Vanessa Trovela, RN 847-952-7165 | |
| Principal Investigator: James Pawlikowski, MD | |
| United States, Ohio | |
| Circleville Foot & Ankle | Completed |
| Circleville, Ohio, United States, 43113 | |
| United States, Texas | |
| Baylor University Medical Center | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Nancy Hawkins, RN 214-818-9688 nancyhaw@BaylorHealth.edu | |
| Principal Investigator: Andrew Applewhite, MD | |
Sponsors and Collaborators
Hollister Incorporated
Investigators
| Study Director: | Ginger Salvadalena, PhD, RN | Hollister Incorporated |
More Information
No publications provided
| Responsible Party: | Hollister Incorporated |
| ClinicalTrials.gov Identifier: | NCT01567150 History of Changes |
| Other Study ID Numbers: | 5064-W |
| Study First Received: | March 23, 2012 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Postphlebitic Syndrome Postthrombotic Syndrome Ulcer Varicose Ulcer Phlebitis Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Venous Insufficiency |
Venous Thrombosis Thrombosis Embolism and Thrombosis Pathologic Processes Varicose Veins Leg Ulcer Skin Ulcer Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013