Lower Limb UlcerNCT01285973
Evaluation of Integra® Artificial Dermis for the Treatment of Leg Ulcers
An observational study of Lower Limb Ulcer, run by Integra LifeSciences Services at 3 sites in 3 countries.
Trial summary
The aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound. This is a multi-centre study on 60 patients who have a lower limb ulcer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lower Limb Ulcer
- How many people
- 30 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2011to Aug 2015
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be patients with "difficult" lower limb ulcers, whose wounds have not responded to directed healing for more than 6 months or who have a wound > 10 cm².
Who may be able to join
- patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (> 10 cm²)
- patients in whom the surgeon has recommended that an Integra® matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis.
- not eligible for skin flap surgery,
- the patient or patient's representative has agreed to sign the information letter before any investigation required by the research.
Who cannot join
- circumferential wound,
- wound infection
- immunosuppressed patient,
- known allergy to bovine collagen, bovine glycosaminoglycans or silicone,
- patients under legal guardianship,
- pregnant women
Show all 9Show fewer
- patients whose health would compromise follow-up for at least 18 months,
- patients whose mental health would compromise completion of the self-evaluation questionnaires.
- wound located in an area not visible by the patient (as no self-assessment would be possible).
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Greece1 site
Aristotle University of Thessaloniki - Papageorgiou General Hospital
Thessaloniki
About this study
The aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound.
This is a multi-centre study on 60 patients who have a lower limb ulcer.
- Conditions
- Lower Limb Ulcer
- Medical subject headings
- Leg Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a greater than 50% reduction in wound surface area during the 18 months after grafting.
Measured: 18 months
Secondary outcomes (5)
Functional complications of healing at 3, 6, 12 and 18 months
Measured: 3, 6, 12 and 18 months
Complete wound healing (reduction in wound surface area >90%)
Measured: 3, 6, 12, 18 months
Pain
Measured: 3, 6, 12, 18 months
Quality of life
Measured: 3, 6, 12, 18 months
Transcutnaeous oxygen pressure (TcPO2)
Measured: 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285973
- Sponsor's protocol ID
- RECON-EMEA-10
- Status last verified
- Aug 2015
- First submitted
- 27 Jan 2011
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Integra® Artificial Dermis for the Treatment of Leg Ulcers
- ClinicalTrials.gov ID
- NCT01285973
- Acronym / sponsor ID
- RECON-EMEA-10
- Conditions
- Lower Limb Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Integra LifeSciences ServicesIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Jan 2011 (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 aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound.
This is a multi-centre study on 60 patients who have a lower limb ulcer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be patients with "difficult" lower limb ulcers, whose wounds have not responded to directed healing for more than 6 months or who have a wound > 10 cm².
Key inclusion criteria (4 listed)
- patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (> 10 cm²)
- patients in whom the surgeon has recommended that an Integra® matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis.
- not eligible for skin flap surgery,
- the patient or patient's representative has agreed to sign the information letter before any investigation required by the research.
Key exclusion criteria (9 listed)
- circumferential wound,
- wound infection
- immunosuppressed patient,
- known allergy to bovine collagen, bovine glycosaminoglycans or silicone,
- patients under legal guardianship,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with a greater than 50% reduction in wound surface area during the 18 months after grafting.
Time frame: 18 months
5 secondary outcomes
Functional complications of healing at 3, 6, 12 and 18 months
Time frame: 3, 6, 12 and 18 months
Complete wound healing (reduction in wound surface area >90%)
Time frame: 3, 6, 12, 18 months
Pain
Time frame: 3, 6, 12, 18 months
Quality of life
Time frame: 3, 6, 12, 18 months
Transcutnaeous oxygen pressure (TcPO2)
Time frame: 6, 12 and 18 months
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 13 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Ulcer, run by Integra LifeSciences Services at 3 sites in 3 countries.
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 9 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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Greece, Italy. 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?
Proportion of patients with a greater than 50% reduction in wound surface area during the 18 months after grafting. (time frame: 18 months). 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 13 Aug 2015.