Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers
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ClinicalTrials.gov Identifier: NCT00797706 |
Recruitment Status
: Unknown
Verified February 2010 by Kringle Pharma Europe AB.
Recruitment status was: Active, not recruiting
First Posted
: November 25, 2008
Last Update Posted
: February 5, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Venous Leg Ulcers | Drug: CHRONSEAL | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 Start Date : | November 2008 |
Estimated Primary Completion Date : | March 2010 |
Estimated Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Vehicle |
Drug: CHRONSEAL
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
|
Experimental: Low dose |
Drug: CHRONSEAL
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
|
Experimental: High dose |
Drug: CHRONSEAL
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
|
- 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 ]
- 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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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797706
Norway | |
Medi3 Innlandet AS, Department Elverum | |
Elverum, Norway, 2402 | |
Hudavdelingen Helse | |
Førde, Norway, 6807 | |
Medi 3 Innlandet AS, Department Hamar | |
Hamar, Norway, 2317 | |
Colosseumklinikken | |
Oslo, Norway, 0369 | |
Sweden | |
Vårdcentralen Alvesta | |
Alvesta, Sweden, 342 30 | |
Danderyds Sjukhus AB | |
Danderyd, Sweden, SE-182 88 | |
Carema Vårdcentral Gubbängen | |
Enskede, Sweden, SE-122 45 | |
Department of Dermatology and Infectious diseases | |
Halmstad, Sweden, SE-301 85 | |
Husläkarna i Kungsbacka | |
Kungsbacka, Sweden, SE-434 30 | |
Department of Dermatology, Lund University hospital | |
Lund, Sweden, SE-221 85 | |
Department of Dermatology, University Hospital MAS | |
Malmö, Sweden, SE-205 02 | |
Gamla Stans Vårdcentral | |
Stockholm, Sweden, SE-111 29 | |
Taptogatans Husläkare | |
Stockholm, Sweden, SE-115 26 | |
Department of Dermatology, Norrlands University hospital | |
Umeå, Sweden, SE-901 85 | |
Department of Medical Sciences, Section of Dermatology and Venereology, Uppsala University hospital | |
Uppsala, Sweden, SE-751 05 | |
Neptunuskliniken | |
Varberg, Sweden, SE-432 44 |
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, |
Responsible Party: | Prof. Anders Vahlne/CEO, Kringle Pharma Europe AB |
ClinicalTrials.gov Identifier: | NCT00797706 History of Changes |
Other Study ID Numbers: |
CS-201 EudraCT No. 2007-002695-34 |
First Posted: | November 25, 2008 Key Record Dates |
Last Update Posted: | February 5, 2010 |
Last Verified: | February 2010 |
Additional relevant MeSH terms:
Ulcer Leg Ulcer Varicose Ulcer Pathologic Processes Skin Ulcer |
Skin Diseases Varicose Veins Vascular Diseases Cardiovascular Diseases |