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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01249495

Enrollment

Registered

2010-11-29

Start date

2010-11-30

Completion date

2013-11-30

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proinflammatory Cytokines, Sharp Debridement, Treatment of Leg Ulcer

Keywords

leg ulcer, wound therapy, Pro-inflammatory interleukins

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.

Interventions

PROCEDURESharp 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Norway

Contacts

Primary ContactTone K Bergersen, MD;PhD

kristin.bergersen@rikshospitalet.no+47 22725829

Backup ContactBrita Pukstad, MD

brita.pukstad@ntnu.no+47 95878012

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026