Wound Fluid Protease Levels During Use of Novel Wound Dressing

NCT01567150 | Completed Phase 4 Results

• 1 other identifier: 5064-W
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Venous Stasis Ulcers

Outcome Measures

Primary Outcomes (1)

• Matrix Metalloproteinase Level in Wound Fluid

  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.

  8 weeks

Secondary Outcomes (1)

• Wound Healing

  12 weeks

Study Arms (2)

novel dressing

ACTIVE COMPARATOR

Treatment with novel dressing

Device: Novel Dressing

Control

NO INTERVENTION

Control is treatment without novel dressing

Interventions

Novel Dressing DEVICE

Topical wound dressing

novel dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hollister Incorporated: lead

Study Sites (8)

Arizona Heart Hospital

Phoenix, Arizona, 85006, United States

Location

Phoenix Baptist Hospital

Phoenix, Arizona, 85015, United States

Location

University of Miami, Department of Surgery, Div. of Vascular Surgery

Miami, Florida, 33136, United States

Location

Alexian Brothers Medical Center Wound Healing Center

Elk Grove Village, Illinois, 60007, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

NYU Langone Medical Center

New York, New York, 10010, United States

Location

Circleville Foot & Ankle

Circleville, Ohio, 43113, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Director, Global Clinical Affairs
• Organization: Hollister Incorporated

ginger.salvadalena@hollister.com

8479183996

Study Officials

• Ginger Salvadalena, PhD, RN

  Hollister Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 30, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: November 25, 2016
• Results First Posted: November 25, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)