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NCT Number: NCT00915486

A Dose Finding Study of Topically Applied I-020201 as an Adjunct to Good Standard-of-care 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.

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Ulcer Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Diabetologické centrum, I. Interní klinika FN Hradec Králové, Fakultní nemocnice Hradec Králové (21), Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Good Standard of Care (GSoC)

Procedure

Procedural treatment twice per week

Vehicle

Biological

Topical fibrin as an adjunct to GSoC twice per week

I-020201

Biological

Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week

Primary outcomes

  1. Percentage reduction in ulcer surface area

    Time frame: 4 weeks after treatment start

Secondary outcomes

  1. Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)

    Time frame: At 12 and 16 weeks after treatment start

  2. 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)

  3. Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards).

    Time frame: At any time during the study

  4. Incidence of treatment failure defined as <30% decrease in ulcer size

    Time frame: After 8 weeks of treatment

  5. Incidence of patients with ulcer recurrence

    Time frame: Up to 16 and 28 weeks after treatment start

  6. Incidence of treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs

    Time frame: During the whole study period

  7. 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

  8. Changes in vital signs, body weight, physical examination and laboratory parameters

    Time frame: Throughout the study and 28 weeks after treatment start

Sponsors and collaborators

Lead sponsor

Kuros Biosurgery AG

Industry

Registry information

Official study 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

Acronym: DFU

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 8, 2009
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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