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

Proinflammatory Cytokines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01249495
• Other study ID #: 2010/736-2
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2010
• Last updated: December 9, 2010
• Start date: November 2010
• Est. completion date: November 2013

Study information

• Verified date: November 2010
• Source: Oslo University Hospital
• Contact: Tone K Bergersen, MD;PhD
• Phone: +47 22725829
• Email: kristin.bergersen[@]rikshospitalet.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Directorate of HealthNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Proinflammatory Cytokines
• Sharp Debridement
• Treatment of Leg Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	St. Olavs Hospital, University Hospital, Aker

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No