NCT01249495

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2010

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 10, 2010

Status Verified

November 1, 2010

Enrollment Period

Same day

First QC Date

November 25, 2010

Last Update Submit

December 9, 2010

Conditions

Treatment of Leg UlcerSharp DebridementProinflammatory Cytokines

Keywords

leg ulcerwound therapyPro-inflammatory interleukins

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Interventions

Sharp debridementPROCEDURE

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ulcus cruris venosoum
  • AAI \> 0.9
  • age 18-80
  • adress Oslo area
  • wound size 2.5-100 cm2
  • wound duration \> 6 weeks.

You may not qualify if:

  • Diabetes mellitus
  • Immunosuppresion
  • antibiotics \< 14 days
  • local antiseptic treatment \< 1 week
  • clinical infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, 0424, Norway

RECRUITING

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tone K Bergersen, MD;PhD

    Oslo University Hospital;Dermatologic Department

    STUDY CHAIR

Central Study Contacts

Tone K Bergersen, MD;PhD

CONTACT

+47 22725829kristin.bergersen@rikshospitalet.no

Brita Pukstad, MD

CONTACT

+47 95878012brita.pukstad@ntnu.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 25, 2010

First Posted

November 29, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2013

Last Updated

December 10, 2010

Record last verified: 2010-11

Locations

NO(1)