Wound Fluid Protease Levels During Use of Novel Wound Dressing
18 Years
N/A
Both
Venous Stasis Ulcers
Trial Information
Wound Fluid Protease Levels During Use of Novel Wound Dressing
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
MMP level in wound fluid
Outcome Description:
Wound fluid will be collected and analyzed at baseline and approximately every 7 days
Outcome Time Frame:
8 weeks
Safety Issue:
No
Principal Investigator
Ginger Salvadalena, PhD, RN
Investigator Role:
Study Director
Investigator Affiliation:
Hollister Incorporated
Authority:
United States: Institutional Review Board
Study ID:
5064-W
NCT ID:
NCT01567150
Start Date:
February 2012
Completion Date:
February 2013
Related Keywords:
- Venous Stasis Ulcers
- Postphlebitic Syndrome
- Postthrombotic Syndrome
- Ulcer
- Varicose Ulcer
Name | Location |
|---|---|
| Alexian Brothers Medical Center Wound Healing Center | Elk Grove Village, Illinois 60007 |
| Circleville Foot & Ankle | Circleville, Ohio 43113 |
