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Wound Fluid Protease Levels During Use of Novel Wound Dressing

Phase 4
18 Years
Open (Enrolling)
Venous Stasis Ulcers

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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:


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:


Principal Investigator

Ginger Salvadalena, PhD, RN

Investigator Role:

Study Director

Investigator Affiliation:

Hollister Incorporated


United States: Institutional Review Board

Study ID:




Start Date:

February 2012

Completion Date:

February 2013

Related Keywords:

  • Venous Stasis Ulcers
  • Postphlebitic Syndrome
  • Postthrombotic Syndrome
  • Ulcer
  • Varicose Ulcer



Alexian Brothers Medical Center Wound Healing CenterElk Grove Village, Illinois  60007
Circleville Foot & AnkleCircleville, Ohio  43113