Wound Fluid Protease Levels During Use of Novel Wound Dressing

Venous Stasis Ulcers Clinical Trial

Official title:

Wound Fluid Protease Levels During Use of Novel Wound Dressing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567150
• Other study ID #: 5064-W
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2012
• Last updated: May 8, 2014
• Start date: February 2012
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: Hollister Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Novel Dressing
Topical wound dressing

Locations

Country	Name	City	State
United States	Circleville Foot & Ankle	Circleville	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Alexian Brothers Medical Center Wound Healing Center	Elk Grove Village	Illinois
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	University of Miami, Department of Surgery, Div. of Vascular Surgery	Miami	Florida
United States	NYU Langone Medical Center	New York	New York
United States	Arizona Heart Hospital	Phoenix	Arizona
United States	Phoenix Baptist Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Hollister Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MMP level in wound fluid	Wound fluid will be collected and analyzed at baseline and approximately every 7 days	8 weeks	No
Secondary	Wound healing (reduction in wound area and incidence of complete closure)		12 weeks	No