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

This study is currently recruiting participants.
Verified November 2010 by Oslo University Hospital
Sponsor:
Collaborators:
St. Olavs Hospital
University Hospital, Aker
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01249495
First received: November 25, 2010
Last updated: December 9, 2010
Last verified: November 2010
History of Changes
  Purpose

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 Intervention
Treatment of Leg Ulcer
Sharp Debridement
Proinflammatory Cytokines
 Procedure: Sharp debridement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Chronic Legg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Wound size


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Pro-inflammatory cytokines


Estimated Enrollment: 50
Study Start Date: November 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 25, 2010
Last Updated: December 9, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health
Norway: Norwegian Social Science Data Services

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

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

ClinicalTrials.gov processed this record on May 22, 2013