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Completed

NCT Number: NCT01567150

Wound Fluid Protease Levels During Use of Novel Wound Dressing

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.

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Key information

Conditions

Venous Stasis Ulcers Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arizona Heart Hospital, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novel Dressing

Device

Topical wound dressing

Primary outcomes

  1. Matrix Metalloproteinase Level in Wound Fluid

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Wound Healing

    Time frame: 12 weeks

    change in wound area mean was calculated for each subject Mean and sd were calculated for each group

Sponsors and collaborators

Lead sponsor

Hollister Incorporated

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 30, 2012
Registry last updated
Nov 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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