Back to resultsTreatment of Chronic Leg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation
Primary Purpose
Treatment of Leg Ulcer, Sharp Debridement, Proinflammatory Cytokines
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Sharp debridement
Sponsored by
About this trial
This is an interventional treatment trial for Treatment of Leg Ulcer focused on measuring leg ulcer, wound therapy, Pro-inflammatory interleukins
Eligibility 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.
Sites / Locations
- Oslo University Hospital, RikshospitaletRecruiting
Outcomes
Primary Outcome Measures
Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation.
Wound size
Secondary Outcome Measures
Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation.
Pro-inflammatory cytokines
Full Information
NCT ID
NCT01249495
First Posted
November 25, 2010
Last Updated
December 9, 2010
Sponsor
Oslo University Hospital
Collaborators
St. Olavs Hospital, University Hospital, Aker
1. Study Identification
Unique Protocol Identification Number
NCT01249495
Brief Title
Treatment of Chronic Leg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation
Official Title
Treatment of Chronic Legg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Oslo University Hospital
Collaborators
St. Olavs Hospital, University Hospital, Aker
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Leg Ulcer, Sharp Debridement, Proinflammatory Cytokines
Keywords
leg ulcer, wound therapy, Pro-inflammatory interleukins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Sharp debridement
Intervention Description
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 Measure Information:
Title
Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation.
Description
Wound size
Time Frame
01.08.10-01.08.13
Secondary Outcome Measure Information:
Title
Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation.
Description
Pro-inflammatory cytokines
Time Frame
01.08.10-01.08.13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tone K Bergersen, MD;PhD
Phone
+47 22725829
Email
kristin.bergersen@rikshospitalet.no
First Name & Middle Initial & Last Name or Official Title & Degree
Brita Pukstad, MD
Phone
+47 95878012
Email
brita.pukstad@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tone K Bergersen, MD;PhD
Organizational Affiliation
Oslo University Hospital;Dermatologic Department
Official's Role
Study Chair
Facility Information:
Facility Name
Oslo University Hospital, Rikshospitalet
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tone Kristin Bergersen, MD, PhD
Phone
+ 47 95 277 814
Email
kristin.bergersen@rikshospitalet.no
First Name & Middle Initial & Last Name & Degree
Tone K Bergersen, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Treatment of Chronic Leg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation
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