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

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Unknown

Conditions

Sharp Debridement
Treatment of Leg Ulcer
Proinflammatory Cytokines

Treatments

Procedure: Sharp debridement

Study type

Interventional

Funder types

Other

Identifiers

NCT01249495
2010/736-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Brita Pukstad, MD; Tone K Bergersen, MD;PhD

Data sourced from clinicaltrials.gov

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