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.

Study Overview

• Status: Unknown
• Conditions: Treatment of Leg Ulcer; Sharp Debridement; Proinflammatory Cytokines
• Intervention / Treatment: Procedure: Sharp debridement

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
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Recruiting
    • Oslo University Hospital, Rikshospitalet
    • Contact: Tone Kristin Bergersen, MD, PhD; Phone Number: + 47 95 277 814; Email: kristin.bergersen@rikshospitalet.no
    • Principal Investigator: Tone K Bergersen, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation.	Wound size	01.08.10-01.08.13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation.	Pro-inflammatory cytokines	01.08.10-01.08.13

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: St. Olavs Hospital; University Hospital, Aker
• Investigators: Study Chair: Tone K Bergersen, MD;PhD, Oslo University Hospital;Dermatologic Department

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): November 1, 2010
• Study Completion (Anticipated): November 1, 2013

Study Registration Dates

• First Submitted: November 25, 2010
• First Submitted That Met QC Criteria: November 26, 2010
• First Posted (Estimate): November 29, 2010

Study Record Updates

• Last Update Posted (Estimate): December 10, 2010
• Last Update Submitted That Met QC Criteria: December 9, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: leg ulcer; wound therapy; Pro-inflammatory interleukins
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Inflammation; Leg Ulcer
• Other Study ID Numbers: 2010/736-2