A Dose Finding Study of Topically Applied I-020201 as an Adjunct to Good Standard-of-care in Patients With Chronic Diabetic Foot Ulcers

Phase 2

Completed

• Conditions: Diabetic Foot Ulcer

• Registration Number: NCT00915486
• Lead Sponsor: Kuros Biosurgery AG

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-08
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage reduction in ulcer surface area	4 weeks after treatment start

Secondary Outcome Measures

Name	Time	Method
Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)	Within the whole study period (28 weeks after treatment start)
Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards).	At any time during the study
Incidence of treatment failure defined as <30% decrease in ulcer size	After 8 weeks of treatment
Incidence of patients with ulcer recurrence	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	During the whole study period
Changes in systemic PDGF-AB and antibody levels against TG-PDGF.AB and aprotinin	At 1, 4, 12, 16 and 20 weeks after treatment start
Changes in vital signs, body weight, physical examination and laboratory parameters	Throughout the study and 28 weeks after treatment start

Trial Locations

Locations (34)

Diabetologické centrum, I. Interní klinika FN Hradec Králové, Fakultní nemocnice Hradec Králové (21); 🇨🇿 Hradec Králové, Czech Republic

Interní klinika 2. Lékařské fakulty UK a FN Motol, Fakultní nemocnice Motol (22); 🇨🇿 Praha, Czech Republic

Lékařský dum Ormiga Angiologická a diabetologická ambulance (20); 🇨🇿 Zlín, Czech Republic

Oddelení diabetologie - Podiatricka ambulance Krajská zdravotní a.s.- Masarykova nemocnice v Ústí nad Labem o.z. (23); 🇨🇿 Ústí nad Labem, Czech Republic

Klinikum Sindelfingen-Böblingen (01); 🇩🇪 Böblingen, Germany

SRH Klinikum Karlsbad-Langensteinbach (04); 🇩🇪 Karlsbad, Germany

Klinikum Stuttgart Bürgerhospital (03); 🇩🇪 Stuttgart, Germany

Universitätsklinik Tübingen Chirugische Poliklinik (02); 🇩🇪 Tübingen, Germany

Budai Irgalmasrendi Közhasznú Non-Profit Kft (35); 🇭🇺 Budapest, Hungary

Fõvárosi Önkormányzat Egyesített Szent István és Szent László Kórház - Rendelõintézet Sebészeti Osztály (32); 🇭🇺 Budapest, Hungary

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