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Treatment of Chronic Leg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation

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ClinicalTrials.gov Identifier: NCT01249495
Recruitment Status : Unknown
Verified November 2010 by Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : November 29, 2010
Last Update Posted : December 10, 2010
Sponsor:
Collaborators:
St. Olavs Hospital
University Hospital, Aker
Information provided by:
Oslo University Hospital

Brief Summary:
The purpose of this study is to investigate the rate of wound healing using sharp debridement using curette and to compare between such intensive treatment at hospital and treatment in primary care. A correlation between change in wound size and pro-inflammatory cytokines will also be made.

Condition or disease Intervention/treatment Phase
Treatment of Leg Ulcer Sharp Debridement Proinflammatory Cytokines Procedure: Sharp debridement Not Applicable

Detailed Description:
Subjects with chronic venous leg ulcers are treated 3 times a week in the hospital for 6 weeks with weekly sharp debridement. Wound size, pro-inflammatory cytokines, smears and photo are made weekly. The treatment countinue thereafter in primary care 3 times a week in 12 weeks. Wound size, pro-inflammatory cytokines, smears and photo are made every 14 day at the hospital.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Chronic Legg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation
Study Start Date : November 2010
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: Sharp debridement
    After use of local anestetics a sharp currette is used to debride slough and nonviable tissue from the ulcer surface until a healthy tissue is seen.


Primary Outcome Measures :
  1. Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation. [ Time Frame: 01.08.10-01.08.13 ]
    Wound size


Secondary Outcome Measures :
  1. Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation. [ Time Frame: 01.08.10-01.08.13 ]
    Pro-inflammatory cytokines



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ulcus cruris venosoum
  • AAI > 0.9
  • age 18-80
  • adress Oslo area
  • wound size 2.5-100 cm2
  • wound duration > 6 weeks.

Exclusion Criteria:

  • Diabetes mellitus
  • Immunosuppresion
  • antibiotics < 14 days
  • local antiseptic treatment < 1 week
  • clinical infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249495


Contacts
Contact: Tone K Bergersen, MD;PhD +47 22725829 kristin.bergersen@rikshospitalet.no
Contact: Brita Pukstad, MD +47 95878012 brita.pukstad@ntnu.no

Locations
Norway
Oslo University Hospital, Rikshospitalet Recruiting
Oslo, Norway, 0424
Contact: Tone Kristin Bergersen, MD, PhD    + 47 95 277 814    kristin.bergersen@rikshospitalet.no   
Principal Investigator: Tone K Bergersen, MD, PhD         
Sponsors and Collaborators
Oslo University Hospital
St. Olavs Hospital
University Hospital, Aker
Investigators
Study Chair: Tone K Bergersen, MD;PhD Oslo University Hospital;Dermatologic Department

Responsible Party: Tone Kristin Bergersen, Oslo University hospital, Rikshospitalet, Dermatologic Department
ClinicalTrials.gov Identifier: NCT01249495     History of Changes
Other Study ID Numbers: 2010/736-2
First Posted: November 29, 2010    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: November 2010

Keywords provided by Oslo University Hospital:
leg ulcer
wound therapy
Pro-inflammatory interleukins

Additional relevant MeSH terms:
Inflammation
Ulcer
Leg Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases