Varicose UlcerNCT00349700
Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers
A study testing Compression: 2 weeks four layer bandages, then stockings, debridement and Actisorb plus (r) + Trionic(r)/ Allevyn (r) in people with Varicose Ulcer, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
The purpose of the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Ulcer
- What is being tested?
- Compression: 2 weeks four layer bandages, then stockings, debridement and Actisorb plus (r) + Trionic(r)/ Allevyn (r)
- Type of treatment
- Surgery or procedure
- How many people
- 139 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2003to May 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- therapy resistant wounds for at least 3 months
- venous disease
- uncle pressure > 80mmHg
- wound area > 20qcm
Who cannot join
- uncle pressure <80mmHg
Trial locations and contacts
1 site in 1 country.
Germany1 site
St. Josef Hospital, Dep. Dermatology and Allergology, Ruhr University Bochum
Bochum, 44791
About this study
Official title: An Open Prospective Controlled Trial: Efficiency of Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers
The purpose of the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze
Read the detailed description
Background: Moist wound therapy of venous leg ulcers is well established by both in vitro or animal studies and studies at ulcers smaller than 20 cm². Mostly larger venous leg ulcers have a stronger exudation than smaller leg ulcers. Therefore larger ulcers exhibit apparently moist conditions also beneath simple gauze, ointments and compresses.
The purpose of the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze.
Patients and Methods: In an open, non-randomized prospective trial 139 consecutive patients (86 female, 53 male) with long standing (159 ± 335 weeks) large sized (> 20 cm², 53.8 ± 90.6 cm²) venous ulcers were included. The pre-treatment with compresses, ointments and gauze and two layer short stretch bandages during the time before consulting our wound outpatient department was compared to the following therapy protocol: After two weeks with four layer bandages compression stockings were applied. After a surgical debridement wound dressings were applied according to exudation (strong: calcium alginate, mean: polyurethane foam, low: hydrocolloid). Critical bacterial colonization was treated by activated charcoal cloth with sil-ver. Criteria for evaluating efficacy were healing time and reduction of ulcer size at the end of observation time.
- Conditions
- Varicose Ulcer
- Being tested
- Compression: 2 weeks four layer bandages, then stockings, debridement, Actisorb plus (r) + Trionic(r)/ Allevyn (r)
- Keywords
- healing, skin, infection, wound therapy
- Medical subject headings
- Varicose Ulcer, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression: 2 weeks four layer bandages, then stockingsProcedure or surgery
debridementProcedure or surgery
Actisorb plus (r) + Trionic(r)/ Allevyn (r)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
the area of leg ulcers was calculated by multiplication of maximal length and width during the first visit an d at least 6 months after first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startJan 2003
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose UlcerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Investigators
- Peter Altmeyer, Prof. Dr., Principal investigator, Ruhr University Bochum, Dep. Dermatology and Allergology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349700
- Sponsor's protocol ID
- 2-Stucker
- Status last verified
- Jul 2006
- First submitted
- 7 Jul 2006
- Last updated
- 6 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Prospective Controlled Trial: Efficiency of Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers
- ClinicalTrials.gov ID
- NCT00349700
- Acronym / sponsor ID
- 2-Stucker
- Conditions
- Varicose Ulcer
- Keywords
- healing, skin, infection, wound therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- May 2005
- First posted
- 10 Jul 2006 (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 the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze
Detailed description
Background: Moist wound therapy of venous leg ulcers is well established by both in vitro or animal studies and studies at ulcers smaller than 20 cm². Mostly larger venous leg ulcers have a stronger exudation than smaller leg ulcers. Therefore larger ulcers exhibit apparently moist conditions also beneath simple gauze, ointments and compresses.
The purpose of the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze.
Patients and Methods: In an open, non-randomized prospective trial 139 consecutive patients (86 female, 53 male) with long standing (159 ± 335 weeks) large sized (> 20 cm², 53.8 ± 90.6 cm²) venous ulcers were included. The pre-treatment with compresses, ointments and gauze and two layer short stretch bandages during the time before consulting our wound outpatient department was compared to the following therapy protocol: After two weeks with four layer bandages compression stockings were applied. After a surgical debridement wound dressings were applied according to exudation (strong: calcium alginate, mean: polyurethane foam, low: hydrocolloid). Critical bacterial colonization was treated by activated charcoal cloth with sil-ver. Criteria for evaluating efficacy were healing time and reduction of ulcer size at the end of observation time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- therapy resistant wounds for at least 3 months
- venous disease
- uncle pressure > 80mmHg
- wound area > 20qcm
Key exclusion criteria (1 listed)
- uncle pressure <80mmHg
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 |
|---|---|---|
| Compression: 2 weeks four layer bandages, then stockings | Procedure or surgery | – |
| debridement | Procedure or surgery | – |
| Actisorb plus (r) + Trionic(r)/ Allevyn (r) | Procedure or surgery | – |
Primary outcome
the area of leg ulcers was calculated by multiplication of maximal length and width during the first visit an d at least 6 months after first visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
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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.
Peter Altmeyer, Prof. Dr. principal investigator
Ruhr University Bochum, Dep. Dermatology and Allergology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression: 2 weeks four layer bandages, then stockings, debridement and Actisorb plus (r) + Trionic(r)/ Allevyn (r) in people with Varicose Ulcer, run by Ruhr University of Bochum at 1 site in Germany.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 6 May 2016. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the area of leg ulcers was calculated by multiplication of maximal length and width during the first visit an d at least 6 months after first visit. 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 6 May 2016.