Treatment of Chronic Leg Ulcer in Outpatient's Department... | NCT01249495

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

NCT01249495

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Dec 10, 2010Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Treatment of Leg Ulcer
Sharp Debridement
Proinflammatory Cytokines

Interventions

Sharp debridement

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Nov 2010Estimated

Completion Date

Nov 2013Estimated

First Submitted Date

Nov 25, 2010

First Submission Date that Met QC Criteria

Nov 26, 2010

First Posted Date

Nov 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2010

Last Update Posted Date

Dec 10, 2010Estimated

Name	Class
St. Olavs Hospital	OTHER
University Hospital, Aker	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sharp debridement	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tone K Bergersen, MD;PhD	Contact	+47 22725829		kristin.bergersen@rikshospitalet.no
Brita Pukstad, MD	Contact	+47 95878012		brita.pukstad@ntnu.no

Overall Officials

Name	Affiliation	Role
Tone K Bergersen, MD;PhD	Oslo University Hospital;Dermatologic Department	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital, Rikshospitalet	Recruiting	Oslo		0424	Norway

Condition Browse Module

MeSH Terms

ID	Term
D007871	Leg Ulcer

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided