BurnsPhase 2NCT00471939
Safety and Efficacy of I-020502 in Meshed Skin Autografting
A Phase 2 study testing I-020502 in people with Burns, run by Kuros Biosurgery AG at 1 site in Germany.
Trial summary
This is a phase II, multi-centre, controlled study comparing the safety and tolerability on wound healing following an application of I-020502 in a concentration of 1μg/mL TG-PDGF.AB versus staples applied in the same patient to burn areas requiring autologous meshed skin grafting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- I-020502
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2007to Jan 2009
- Phase
- Phase 2
- 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
- Written informed consent by the patient or his/her legal representative.
- Male or female, aged ≥ 18 years.
- Female with childbearing potential with a negative pregnancy test within 3 day prior to surgery (screening).
- Patients with burn wound(s) between ≥ 5 % and ≤ 50 % TBSA.
- Patients with a contiguous deep partial thickness/full thickness wound(s) of two comparable sites either contiguous or separate in the same location (e.g. leg) each sized between 1% and 2% TBSA but not more than 400 cm2.
- Patients who are willing to comply with treatment applications and instructions by the protocol.
Who cannot join
- Females who are pregnant or breast-feeding.
- Patients with known or suspected allergies to any of the components of the wound healing gel I-020502 (e.g. hypersensitivity to bovine proteins).
- Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites.
- Electrical and/or chemical burns.
- Patients that are judged to have significant pulmonary compromise.
- Transcutaneous tissue oxygenation < 90%.
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- Clinically significant infections at wound sites.
- Clinically significant systemic infections.
- Suspicion or presence of active systemic or local cancer or tumor of any kind.
- Patients with known immunodeficiency disorders, either congenital or acquired.
- Patients with vascular or skin disorders that directly affect the designated wound site.
- Patients with Diabetes mellitus.
- Patients with chronic malnourishment.
- Chronic treatment with immunosuppressive drugs or systemic corticosteroids within the last 2 months prior to surgery.
- Any other acute or chronic concurrent medical conditions that in the Investigator's opinion are a contraindication to skin mesh grafting and study participation.
- Participation in another investigational study within 30 days prior to surgery, for investigational devices, or within the last three months for investigational drugs related to wound healing.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte
Bochum, 44789
About this study
Official title: A Phase II, Multi-Centre, Controlled Study of the Safety and Efficacy of Wound Healing Gel I-020502 (KUR-212) in Patients Undergoing Autologous Meshed Skin Grafting.
This is a phase II, multi-centre, controlled study comparing the safety and tolerability on wound healing following an application of I-020502 in a concentration of 1μg/mL TG-PDGF.AB versus staples applied in the same patient to burn areas requiring autologous meshed skin grafting.
- Conditions
- Burns
- Being tested
- I-020502
- Keywords
- Burn, Meshed skin graft, PDGF, deep partial thickness or full thickness burns
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-020502Drug
1 mcg/mL TG-PDGF.AB
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related adverse events up to 28 days post surgery
Measured: 28 days
Secondary outcomes (1)
Incidence of AE/SAE, Changes in vital signs, Hematology/clinical chemistry, PDGF.AB/TG-PDGF.AB and antibodies, hypergranulation, Percentage and proportion of re-epithelialization/engraftment, Scar assessment, Time and resources for test site treatments
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2007
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuros Biosurgery AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter BioScience
- Investigators
- Marcus Lehnhardt, Dr., Principal investigator, Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471939
- Sponsor's protocol ID
- CS I-020502/01
- Status last verified
- Mar 2009
- First submitted
- 9 May 2007
- Last updated
- 3 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-Centre, Controlled Study of the Safety and Efficacy of Wound Healing Gel I-020502 (KUR-212) in Patients Undergoing Autologous Meshed Skin Grafting.
- ClinicalTrials.gov ID
- NCT00471939
- Acronym / sponsor ID
- CS I-020502/01
- Conditions
- Burns
- Keywords
- Burn, Meshed skin graft, PDGF, deep partial thickness or full thickness burns
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kuros Biosurgery AGIndustry (pharma, biotech, devices)
- Collaborators
- Baxter BioScience
- Study start
- Apr 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 May 2007 (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.
This is a phase II, multi-centre, controlled study comparing the safety and tolerability on wound healing following an application of I-020502 in a concentration of 1μg/mL TG-PDGF.AB versus staples applied in the same patient to burn areas requiring autologous meshed skin grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- 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 (6 listed)
- Written informed consent by the patient or his/her legal representative.
- Male or female, aged ≥ 18 years.
- Female with childbearing potential with a negative pregnancy test within 3 day prior to surgery (screening).
- Patients with burn wound(s) between ≥ 5 % and ≤ 50 % TBSA.
- Patients with a contiguous deep partial thickness/full thickness wound(s) of two comparable sites either contiguous or separate in the same location (e.g. leg) each sized between 1% and 2% TBSA but not more than 400 cm2.
Key exclusion criteria (16 listed)
- Females who are pregnant or breast-feeding.
- Patients with known or suspected allergies to any of the components of the wound healing gel I-020502 (e.g. hypersensitivity to bovine proteins).
- Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites.
- Electrical and/or chemical burns.
- Patients that are judged to have significant pulmonary compromise.
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 |
|---|---|---|
| I-0205021 mcg/mL TG-PDGF.AB | Drug | – |
Primary outcome
Incidence of treatment-related adverse events up to 28 days post surgery
Time frame: 28 days
1 secondary outcome
Incidence of AE/SAE, Changes in vital signs, Hematology/clinical chemistry, PDGF.AB/TG-PDGF.AB and antibodies, hypergranulation, Percentage and proportion of re-epithelialization/engraftment, Scar assessment, Time and resources for test site treatments
Time frame: 28 days
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 3 Mar 2009.
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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.
Marcus Lehnhardt, Dr. principal investigator
Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing I-020502 in people with Burns, run by Kuros Biosurgery AG 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 6 inclusion and 16 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 3 Mar 2009. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of treatment-related adverse events up to 28 days post surgery (time frame: 28 days). 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 3 Mar 2009.