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

Not Applicable

• Conditions: Treatment of Leg Ulcer; Sharp Debridement; Proinflammatory Cytokines

• Registration Number: NCT01249495
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2010-11
• Study Start: 2010-11
• Primary Completion: 2010-11
• Study First Submitted: 2010-11-25
• Study First Submitted QC: 2010-11-26
• Study First Posted: 2010-11-29
• Last Update Submitted: 2010-12-09
• Last Update Posted: 2010-12-10
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway