Treatment of Leg UlcerNCT01249495
Treatment of Chronic Leg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation
A study testing Sharp debridement in people with Treatment of Leg Ulcer and Sharp Debridement, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment of Leg Ulcer, Sharp Debridement, Proinflammatory Cytokines
- What is being tested?
- Sharp debridement
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2010to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ulcus cruris venosoum
- AAI > 0.9
- age 18-80
- adress Oslo area
- wound size 2.5-100 cm2
- wound duration > 6 weeks.
Who cannot join
- Diabetes mellitus
- Immunosuppresion
- antibiotics < 14 days
- local antiseptic treatment < 1 week
- clinical infection.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital, Rikshospitalet
Oslo, 0424
Tone Kristin Bergersen, MD, PhD, + 47 95 277 814, kristin.bergersen@rikshospitalet.no
Tone K Bergersen, MD, PhD
About this study
Official title: Treatment of Chronic Legg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation
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.
Read the 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.
- Being tested
- Sharp debridement
- Keywords
- leg ulcer, wound therapy, Pro-inflammatory interleukins
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sharp debridementProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation.
Wound size
Measured: 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.
Pro-inflammatory cytokines
Measured: 01.08.10-01.08.13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2010 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Leg UlcerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital, Aker
- Investigators
- Tone K Bergersen, MD;PhD, Study chair, Oslo University Hospital;Dermatologic Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249495
- Sponsor's protocol ID
- 2010/736-2
- Status last verified
- Nov 2010
- First submitted
- 25 Nov 2010
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Legg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation
- ClinicalTrials.gov ID
- NCT01249495
- Acronym / sponsor ID
- 2010/736-2
- Keywords
- leg ulcer, wound therapy, Pro-inflammatory interleukins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital, Aker
- Study start
- Nov 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 29 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ulcus cruris venosoum
- AAI > 0.9
- age 18-80
- adress Oslo area
- wound size 2.5-100 cm2
Key exclusion criteria (5 listed)
- Diabetes mellitus
- Immunosuppresion
- antibiotics < 14 days
- local antiseptic treatment < 1 week
- clinical infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sharp debridementAfter 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. | Procedure or surgery | – |
Primary outcome
Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation.
Time frame: 01.08.10-01.08.13
Wound size
1 secondary outcome
Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation.
Time frame: 01.08.10-01.08.13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tone K Bergersen, MD;PhD study chair
Oslo University Hospital;Dermatologic Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sharp debridement in people with Treatment of Leg Ulcer and Sharp Debridement, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tone K Bergersen, MD;PhD (+47 22725829, kristin.bergersen@rikshospitalet.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation. (time frame: 01.08.10-01.08.13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2010.