Non-malignant full skin chronic venous leg ulcers of an area 3 - 20 cm2. MedDRA version: 9.1 Level: LLT Classification code 10047260 Term: Venous ulceration
Conditions
Interventions
Product Name: ChronSeal (50)
Product Code: n.a.
Pharmaceutical Form: Cream
INN or Proposed INN: 5 amino acid deleted recombinant human Hepatocyte Growth Factor
Current Sponsor code: KP-dHGF
Other desc
Sponsors
Kringle Pharma Europe AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: RUN-IN PERIOD INCLUSION CRITERIA - SUBJECT 1. Caucasian male or clinically sterile female subjects (postmenopausal > 12 months (confirmed as FSH > 30 mU/ml if in doubt), hysterectomy or tubal ligation) 2. 40 years or older. 3. Ankle brachial index of at least 0.6. 4. Written informed consent obtained, and a copy provided to the subject. 5. Subject legally competent and able to communicate effectively with the study personnel. 6. Subject likely to co-operate. INCLUSION CRITERIA - TARGET ULCER (= the worst ulcer to fulfil the inclusion criteria) 7. Uncomplicated venous ulcer as by clinical diagnosis. 8. Full skin ulcer. 9. Localisation above the foot and below the knee (wrist and malleole included) 10. Duration of at least 3 months. 11. Area 3-20 cm2. RANDOMISATION (after fulfilled run-in period) INCLUSION CRITERIA - SUBJECT 1. Subject likely to co-operate. INCLUSION CRITERIA - TARGET ULCER 2. Ulcer area reduction less than 50% during run-in period. 3. Ulcer area 3-20 cm2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: RUN-IN PERIOD EXCLUSION CRITERIA - TARGET ULCER (= the worst ulcer to fulfil inclusion criteria) 1. Visible signs of infection, black necrosis or discharge in the target ulcer. 2. More than ~20% slough after debridement. 3. Ulcer that by location or extension will either be difficult to follow or to treat according to the protocol e.g. placement difficult for photography, multiple close ulcers, or tissue undermining/sinus tracts. 4. Other known etiology of the target ulcer e.g. malignancy, vasculitis or severe clinical overt ischemia. EXCLUSION CRITERIA - SUBJECT 5. Subject having to the discretion of the investigator clinically significant findings on physical examination or vital signs. 6. 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. 7. Concomitant systemic treatment within 14 days prior to start of study medication with immunosuppressives 8. 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 9. Diabetes Mellitus requiring pharmaceutical treatment. 10. Co-morbidity with a life expectancy less than 6 months. 11. Co-morbidity expected to lower compliance. 12. Diagnosed kidney disease 13. Individuals sensitive to any of the study medication components. 14. 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. 15. Known abuse of alcohol, drugs or pharmaceuticals. 16. Diagnosis of invasive squamos epithelia carcinoma 17. Diagnoses of a serious psychiatric illness which may influence study participation. RANDOMISATION (after fulfilled run-in period) EXCLUSION CRITERIA - TARGET ULCER 1. Visible signs of infection, black necrosis or discharge in the target ulcer. 2. More than ~20% of the ulcer area slough after debridement. EXCLUSION CRITERIA - SUBJECT 3. Subject having to the discretion of the investigator clinically significant findings on vital signs or laboratory values. 4. 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. 5. Concomitant systemic treatment within 14 days prior to start of study medication with immunosuppressives 6. 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 7. Co-morbidity expected to lower compliance. 8. Diagnosed kidney disease. 9. Individuals sensitive to any of the study medication components. 10. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to investigate safety and local tolerance of CHRONSEAL® cream containing 7.1 or 35.7 ng KP-dHGF/g, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle. ;Secondary Objective: Secondary objectives are to investigate the treatment effect on ulcer area reduction and changes in ulcer condition of CHRONSEAL® cream, containing 7.1 or 35.7 ng KP-dHGF/g, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle. ;Primary end point(s): Primary study endpoints • Safety (number and type of adverse events) • Local tolerance | — |
Countries
Sweden
Outcome results
None listed