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

NCT ID: NCT01249495

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Treatment of Leg Ulcer Sharp Debridement Proinflammatory Cytokines

Keywords

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leg ulcer wound therapy Pro-inflammatory interleukins

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

University Hospital, Aker

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Oslo University hospital, Rikshospitalet, Dermatologic Department

Principal Investigators

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Tone K Bergersen, MD;PhD

Role: STUDY_CHAIR

Oslo University Hospital;Dermatologic Department

Locations

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Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Tone K Bergersen, MD;PhD

Role: CONTACT

Phone: +47 22725829

Email: [email protected]

Brita Pukstad, MD

Role: CONTACT

Phone: +47 95878012

Email: [email protected]

Facility Contacts

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Tone Kristin Bergersen, MD, PhD

Role: primary

Other Identifiers

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2010/736-2

Identifier Type: -

Identifier Source: org_study_id