Diabetic Foot UlcerPhase 2DFUNCT00915486
A Dose Finding Study of Topically Applied I-020201 as an Adjunct to Good Standard-of-care in Patients With Chronic Diabetic Foot Ulcers
A Phase 2 study testing I-020201 in people with Diabetic Foot Ulcer, run by Kuros Biosurgery AG at 34 sites in 6 countries.
Trial summary
Although major improvements in the management and treatment of diabetic foot ulcers have been made, the clinical and financial burden of such long-term wounds is still high and is likely to increase as the general population ages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- I-020201
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 34 sitesin 6 countries
- Study dates
- May 2009to Mar 2012
- 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
- male or female, aged ≥ 18 years
- given written informed consent
- female of childbearing potential with a negative result from the pregnancy test at screening who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial
- Type 1 or Type 2 Diabetes mellitus with HbA1c =< 12%
- with only one diabetic foot ulcer on the foot to be treated on or below the ankle
Who cannot join
- pregnant or breast-feeding
- known or suspected allergies to any of the components of the I-020201
- uncontrolled anemia (Hb < 9 g/dL in females and < 10 g/dL in males)
- hypoalbuminemia (albumin < 3 g/dL)
- overtly infected target ulcer (as judged by investigator)
- highly exuding wounds (wounds that require a daily dressing change)
Show all 15Show fewer
- osteomyelitis
- systemic infections
- acute Charcot foot and severe chronic Charcot deformity
- ABPI < 0.7 or ankle systolic pressure < 70 mm Hg
- one of the following findings (only 1 out of 3 tests is required):
- on Doppler waveform analysis on the dorsalis pedis and posterior tibial arteries a monophasic or biphasic flow (with loss of reverse flow) in either foot artery, or
- a toe: brachial index < 0.7, or
- transcutaneous oxygen pressure (TcpO2) < 40 mm Hg
- suspicion, presence or history of systemic or local cancer or tumor of any kind
Trial locations and contacts
34 sites in 6 countries.
34 sites in 6 countries
Hungary9 sites
Budai Irgalmasrendi Közhasznú Non-Profit Kft (35)
Budapest, 1027
Fõvárosi Önkormányzat Egyesített Szent István és Szent László Kórház - Rendelõintézet Sebészeti Osztály (32)
Budapest, 1097
Fővárosi Önkormányzat Szent Imre Kórház Operativ Szakmák Mátrix Szervezete Általános Sebészeti Profil (33)
Budapest, 1115
Esztergom Város Önkormányzat Vaszary Kolos Kórház Sebészeti Osztály (34)
Esztergom, 2500
Kaposi Mór Oktató Kórház (38)
Kaposvár, 7400
Bács-Kiskun Megyei Önkormányzat Kórháza Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza, 2. Belgyógyászat (31)
Kecskemét, 6000
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház Érsebészeti Osztály (30)
Miskolc, 3526
PTE Klinikai Központ Érsebészeti Klinikai Tanszék (36)
Pécs, 7623
SZTE Szent-Györgyi Albert Klinikai Centrum (37)
Szeged, 6720
Russia7 sites
Moscow City Clinical Hospital # 13 (11)
Moscow, 115280
Moscow State University of Public Health "City Clinical (17)
Moscow, 115432
Department of Endocrinology and Diabetes, Russian State Medical University, Moscow City Clinical Hospital # 1 (15)
Moscow, 117049
Department of Diabetic Foot Endocrinology dispensary (12)
Moscow, 119034
Endocrinology Clinic of the State Educational Institute of High Professional Education (18)
Moscow, 119992
Federal State Institution "Federal Bureau of Medical Social Expertise" (10)
Moscow, 123448
Moscow Clinical Hospital # 81 (14)
Moscow, 127644
Romania5 sites
Institutul Naţional de Diabet, Nutriţie şi Boli Metabolice "Prof. Dr. N. C. Paulescu" (42)
Bucharest, 020475
Spitalul Clinic Judeţean de Urgenţă Cluj (43)
Cluj-Napoca, 400006
Spitalul Clinic Judeţean Mureş, Clinica de Dermatologie (40)
Tg Mures, 540342
Cabinet Medical Individual DermaMed (41)
Tg. Mures,, 540530
Spitalul Clinic Judetean de Urgenta Timisoara (45)
Timișoara, 300723
Serbia5 sites
Klinički centar Srbije, Institut za endokrinologiju, dijabetes i bolesti metabolizma (51)
Belgrade, 11 000
Clinical Centre Kragujevac (54)
Kragujevac, 34 000
Clinical Centre Nis (50)
Niš, 18000
Clinical Centre of Vojvodina (53)
Novi Sad, 21 000
Health Centre Valjevo (52)
Valjevo, 14 000
Czechia4 sites
Diabetologické centrum, I. Interní klinika FN Hradec Králové, Fakultní nemocnice Hradec Králové (21)
Hradec Králové, 500 05
Interní klinika 2. Lékařské fakulty UK a FN Motol, Fakultní nemocnice Motol (22)
Prague, 150 06
Oddelení diabetologie - Podiatricka ambulance Krajská zdravotní a.s.- Masarykova nemocnice v Ústí nad Labem o.z. (23)
Ústí nad Labem, 401 13
Lékařský dum Ormiga Angiologická a diabetologická ambulance (20)
Zlín, 760 01
Germany4 sites
Klinikum Sindelfingen-Böblingen (01)
Böblingen, 71031
SRH Klinikum Karlsbad-Langensteinbach (04)
Karlsbad, 76307
Klinikum Stuttgart Bürgerhospital (03)
Stuttgart, 70191
Universitätsklinik Tübingen Chirugische Poliklinik (02)
Tübingen, 72076
About this study
Official title: A Randomized, Multi-center, Controlled, Parallel Group, Dose Finding Study of the Efficacy and Safety of Topically Applied I-020201 as an Adjunct to Good Standard-of-care Versus Good Standard-of-care Alone in Patients With Chronic Diabetic Foot Ulcers
Although major improvements in the management and treatment of diabetic foot ulcers have been made, the clinical and financial burden of such long-term wounds is still high and is likely to increase as the general population ages. The large population affected by diabetic foot ulcers and the high rates of failure ending with amputation even with the best therapeutic regimens have resulted in the development of new therapies. I-020201 is a bioactive therapy intended for topical treatment of hard-to-heal diabetic foot ulcers, stimulating the granulation tissue formation. This study aims to evaluate the safety and efficacy of I-020201 in adjunct to good standard of care in patients with chronic diabetic foot ulcer.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Good Standard of Care (GSoC), Vehicle, I-020201
- Keywords
- Diabetic, ulcer, topical, PDGF, GSoC
- Medical subject headings
- Diabetic Foot, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Good Standard of Care (GSoC)Procedure or surgery
Procedural treatment twice per week
VehicleBiological
Topical fibrin as an adjunct to GSoC twice per week
I-020201Biological
Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week
| Study group | Role | What they receive |
|---|---|---|
| Good Standard of Care (GSoC) | Experimental | Twice per week Receives: Procedure: Good Standard of Care (GSoC) |
| GSoC + vehicle | Experimental | Twice per week Receives: Procedure: Good Standard of Care (GSoC); Biological: Vehicle |
| GSoC + I-020201 (33microg) | Experimental | Twice per week Receives: Procedure: Good Standard of Care (GSoC); Biological: I-020201 |
| GSoC + I-020201 (100microg) | Experimental | Twice per week Receives: Procedure: Good Standard of Care (GSoC); Biological: I-020201 |
| GSoC + I-020201 (300microg) | Experimental | Twice per week Receives: Procedure: Good Standard of Care (GSoC); Biological: I-020201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in ulcer surface area
Measured: 4 weeks after treatment start
Secondary outcomes (8)
Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)
Measured: At 12 and 16 weeks after treatment start
Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)
Measured: Within the whole study period (28 weeks after treatment start)
Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards).
Measured: At any time during the study
Incidence of treatment failure defined as <30% decrease in ulcer size
Measured: After 8 weeks of treatment
Incidence of patients with ulcer recurrence
Measured: Up to 16 and 28 weeks after treatment start
Incidence of treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs
Measured: During the whole study period
Changes in systemic PDGF-AB and antibody levels against TG-PDGF.AB and aprotinin
Measured: At 1, 4, 12, 16 and 20 weeks after treatment start
Changes in vital signs, body weight, physical examination and laboratory parameters
Measured: Throughout the study and 28 weeks after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuros Biosurgery AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Virginia Jamieson, MD, Study director, Kuros Biosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915486
- Sponsor's protocol ID
- CS I-020201/01
- Acronym
- DFU
- Status last verified
- Mar 2012
- First submitted
- 5 Jun 2009
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Controlled, Parallel Group, Dose Finding Study of the Efficacy and Safety of Topically Applied I-020201 as an Adjunct to Good Standard-of-care Versus Good Standard-of-care Alone in Patients With Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00915486
- Acronym / sponsor ID
- DFU / CS I-020201/01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic, ulcer, topical, PDGF, GSoC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Kuros Biosurgery AGIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 8 Jun 2009 (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.
Although major improvements in the management and treatment of diabetic foot ulcers have been made, the clinical and financial burden of such long-term wounds is still high and is likely to increase as the general population ages. The large population affected by diabetic foot ulcers and the high rates of failure ending with amputation even with the best therapeutic regimens have resulted in the development of new therapies. I-020201 is a bioactive therapy intended for topical treatment of hard-to-heal diabetic foot ulcers, stimulating the granulation tissue formation. This study aims to evaluate the safety and efficacy of I-020201 in adjunct to good standard of care in patients with chronic diabetic foot ulcer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Good Standard of Care (GSoC) | Experimental | Procedure: Good Standard of Care (GSoC)Twice per week |
| GSoC + vehicle | Experimental | Procedure: Good Standard of Care (GSoC), Biological: VehicleTwice per week |
| GSoC + I-020201 (33microg) | Experimental | Procedure: Good Standard of Care (GSoC), Biological: I-020201Twice per week |
| GSoC + I-020201 (100microg) | Experimental | Procedure: Good Standard of Care (GSoC), Biological: I-020201Twice per week |
| GSoC + I-020201 (300microg) | Experimental | Procedure: Good Standard of Care (GSoC), Biological: I-020201Twice per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male or female, aged ≥ 18 years
- given written informed consent
- female of childbearing potential with a negative result from the pregnancy test at screening who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial
- Type 1 or Type 2 Diabetes mellitus with HbA1c =< 12%
- with only one diabetic foot ulcer on the foot to be treated on or below the ankle
Key exclusion criteria (15 listed)
- pregnant or breast-feeding
- known or suspected allergies to any of the components of the I-020201
- uncontrolled anemia (Hb < 9 g/dL in females and < 10 g/dL in males)
- hypoalbuminemia (albumin < 3 g/dL)
- overtly infected target ulcer (as judged by investigator)
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 |
|---|---|---|
| Good Standard of Care (GSoC)Procedural treatment twice per week | Procedure or surgery | GSoC + I-020201 (100microg), GSoC + I-020201 (300microg), GSoC + I-020201 (33microg), GSoC + vehicle, Good Standard of Care (GSoC) |
| VehicleTopical fibrin as an adjunct to GSoC twice per week | Biological | GSoC + vehicle |
| I-020201Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week | Biological | GSoC + I-020201 (100microg), GSoC + I-020201 (300microg), GSoC + I-020201 (33microg) |
Primary outcome
Percentage reduction in ulcer surface area
Time frame: 4 weeks after treatment start
8 secondary outcomes
Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)
Time frame: At 12 and 16 weeks after treatment start
Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)
Time frame: Within the whole study period (28 weeks after treatment start)
Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards).
Time frame: At any time during the study
Incidence of treatment failure defined as <30% decrease in ulcer size
Time frame: After 8 weeks of treatment
Incidence of patients with ulcer recurrence
Time frame: Up to 16 and 28 weeks after treatment start
Incidence of treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs
Time frame: During the whole study period
Changes in systemic PDGF-AB and antibody levels against TG-PDGF.AB and aprotinin
Time frame: At 1, 4, 12, 16 and 20 weeks after treatment start
Changes in vital signs, body weight, physical examination and laboratory parameters
Time frame: Throughout the study and 28 weeks after treatment start
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 16 Mar 2012.
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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.
Virginia Jamieson, MD study director
Kuros Biosurgery
34 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing I-020201 in people with Diabetic Foot Ulcer, run by Kuros Biosurgery AG at 34 sites in 6 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 5 inclusion and 15 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 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Hungary, Russia, Romania, Serbia, Czechia and 1 more country. 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?
Percentage reduction in ulcer surface area (time frame: 4 weeks after treatment start). 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 16 Mar 2012.