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Wound Fluid Protease Levels During Use of Novel Wound Dressing

NCT ID: NCT01567150

Last Updated: 2016-11-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Venous Stasis Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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novel dressing

Treatment with novel dressing

Group Type ACTIVE_COMPARATOR

Novel Dressing

Intervention Type DEVICE

Topical wound dressing

Control

Control is treatment without novel dressing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Novel Dressing

Topical wound dressing

Intervention Type DEVICE

Eligibility Criteria

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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 Institutional Review Board 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hollister Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ginger Salvadalena, PhD, RN

Role: STUDY_DIRECTOR

Hollister Incorporated

Locations

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Arizona Heart Hospital

Phoenix, Arizona, United States

Site Status

Phoenix Baptist Hospital

Phoenix, Arizona, United States

Site Status

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

Miami, Florida, United States

Site Status

Alexian Brothers Medical Center Wound Healing Center

Elk Grove Village, Illinois, United States

Site Status

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Site Status

NYU Langone Medical Center

New York, New York, United States

Site Status

Circleville Foot & Ankle

Circleville, Ohio, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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5064-W

Identifier Type: -

Identifier Source: org_study_id