- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00797706
Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers
A Phase I/II Double-Blind, Dose Ranging, Vehicle Controlled, Randomized, Parallel Groups, Safety, Tolerability and Efficacy Study of CHRONSEAL® (5-amino-acid Deleted Recombinant Human Hepatocyte Growth Factor (KP-dHGF)), in Subjects With Venous Leg Ulcers
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Elverum, Norway, 2402
- Medi3 Innlandet AS, Department Elverum
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Førde, Norway, 6807
- Hudavdelingen Helse
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Hamar, Norway, 2317
- Medi 3 Innlandet AS, Department Hamar
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Oslo, Norway, 0369
- Colosseumklinikken
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Alvesta, Sweden, 342 30
- Vårdcentralen Alvesta
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Danderyd, Sweden, SE-182 88
- Danderyds sjukhus AB
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Enskede, Sweden, SE-122 45
- Carema Vårdcentral Gubbängen
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Halmstad, Sweden, SE-301 85
- Department of Dermatology and Infectious diseases
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Kungsbacka, Sweden, SE-434 30
- Husläkarna i Kungsbacka
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Lund, Sweden, SE-221 85
- Department of Dermatology, Lund University hospital
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Malmö, Sweden, SE-205 02
- Department of Dermatology, University Hospital MAS
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Stockholm, Sweden, SE-111 29
- Gamla Stans Vårdcentral
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Stockholm, Sweden, SE-115 26
- Taptogatans Husläkare
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Umeå, Sweden, SE-901 85
- Department of Dermatology, Norrlands University hospital
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Uppsala, Sweden, SE-751 05
- Department of Medical Sciences, Section of Dermatology and Venereology, Uppsala University hospital
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Varberg, Sweden, SE-432 44
- Neptunuskliniken
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria (Run-in period):
- Caucasian male or clinically sterile female subjects
- 40 years or older.
- Ankle brachial index of at least 0.6.
- Written informed consent obtained.
- Subject legally competent and able to communicate effectively.
- Subject likely to co-operate.
- Uncomplicated venous ulcer as by clinical diagnosis.
- Full skin ulcer.
- Localisation above the foot and below the knee (wrist and malleoli included)
- Duration of at least 3 months.
- Area 3-20 cm2.
Exclusion criteria (Run-in period)
- Visible signs of infection, black necrosis or discharge in the target ulcer.
- More than ~20% slough after debridement.
- Ulcer that by location or extension will either be difficult to follow or to treat according to the protocol.
- Other known etiology of the target ulcer.
- Subject having to the discretion of the investigator clinically significant findings on physical examination or vital signs.
- Concomitant systemic or topical treatment within 14 days prior to start of study medication with antibiotics or antiseptics for treatment of ulcer infection in target ulcer.
- Concomitant systemic treatment within 14 days prior to start of study medication with immunosuppressives
Concomitant topical treatment within 14 days prior to start of study medication with any of the following:
- NSAIDs, aspirin
- Growth factors, or other biologically active agents
- Products containing chlorhexidine, potassium permanganate, iodine or silver
- Diabetes Mellitus requiring pharmaceutical treatment.
- Co-morbidity with a life expectancy less than 6 months.
- Co-morbidity expected to lower compliance.
- Diagnosed kidney disease
- Individuals sensitive to any of the study medication components.
- Subject having received an investigational drug product, or been enrolled in other investigational drug protocols within a period of 30 days prior to receiving the first dose of the study medication.
- Known abuse of alcohol, drugs or pharmaceuticals.
- Diagnosis of squamous epithelia carcinoma
- Diagnoses of a serious psychiatric illness which may influence study participation.
Inclusion criteria (Randomization)
- Subject likely to co-operate.
- Ulcer area reduction less than 50% during run-in period.
- Ulcer area 3-20 cm2.
Exclusion criteria (Randomization)
1.& 2. = Run-in period criteria 1. & 2.
3. Subject having to the discretion of the investigator clinically significant findings on vital signs or laboratory values.
4.-10. = Run-in period criteria 6., 7., 8., 11., 12., 13., & 14
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Vehicle
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Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
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Experimental: Low dose
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Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
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Experimental: High dose
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Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To investigate safety and local tolerance of CHRONSEAL® cream containing 2 different concentrations of API, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle.
Time Frame: From start of treatment to 12 weeks post treatment
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From start of treatment to 12 weeks post treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To investigate the treatment effect on ulcer area reduction and changes of ulcer condition of CHRONSEAL® cream, containing 2 different concentrations API, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle.
Time Frame: From start of treatment to 12 weeks post treatment
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From start of treatment to 12 weeks post treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hans Olav Høivik, MD, Medi 3 Innlandet AS, avd Hamar
- Principal Investigator: Karin Andersson, MD, Halland County Council, Department of Dermatology and Infectious diseases, Halmstad, Sweden
- Study Chair: Jan Apelqvist, Assoc. Prof., PhD, MD, Department of Endocrinology, University Hospital Malmö,
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS-201
- EudraCT No. 2007-002695-34
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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