Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Oslo University Hospital.
Recruitment status was  Recruiting
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

November 25, 2010
December 9, 2010
November 2010
November 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01249495 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Treatment of Chronic Leg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation
Treatment of Chronic Legg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Treatment of Leg Ulcer
  • Sharp Debridement
  • Proinflammatory Cytokines
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
November 2013
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
Yes
Contact: Tone K Bergersen, MD;PhD +47 22725829 kristin.bergersen@rikshospitalet.no
Contact: Brita Pukstad, MD +47 95878012 brita.pukstad@ntnu.no
Norway
 
NCT01249495
2010/736-2
No
Tone Kristin Bergersen, Oslo University hospital, Rikshospitalet, Dermatologic Department
Oslo University Hospital
  • St. Olavs Hospital
  • University Hospital, Aker
Study Chair: Tone K Bergersen, MD;PhD Oslo University Hospital;Dermatologic Department
Oslo University Hospital
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP