Venous leg ulcer (ulcus cruris)
Conditions
Interventions
Product Name: DermaPro
Product Code: DPOCl
Pharmaceutical Form: Concentrate for cutaneous solution
Pharmaceutical form of the placebo: Cutaneous solution
Route of administration of the placebo: Intral
Sponsors
DermaTools Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient must give written informed consent, after having been informed about the benefits and potential risks of the study, as well as details of the insurance taken out to cover the patients participating in the study 2. Age: >18 years, inclusive 3. One or more chronic venous foot ulcer (ulcus cruris) between knee and ankle (lower leg) with a mean area of at least 4.0 and a maximum of 60 cm² after debridement (if indicated).. Wound shapes other than circular must have a both length and width of at least 2.0 cm, 4. Clinical findings consistent with established venous disease (such as skin hyperpigmentation, hypopigmentation, varicose veins, lipodermatosclerosis) confirmed by venous Doppler duplex ultrasonography. 5. If other ulcerations are present at the same leg, they must be >2cm apart from the target wound 6. Adequate perfusion of the lower leg as determined by an ABI > 0.85 for the leg to be treated 7. Females of non-childbearing potential defined as being amenorrheal for longer than 2 years with an appropriate clinical profile or surgically sterile. If of childbearing potential the patient must use an adequate birth control and must have a negative pregnancy test. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1. New ulcers (first appearance less than 4 weeks) or ulcers, which have been treated over the last 4 weeks and showed a reduction of wound size of > 25% 2. Target wound showed healing tendency between screening and enrolment 3. Local antibiotic therapy of the target wounds selected for the study 4. Known or suspicion of osteomyelitis at the target leg 5. Other wounds of different aetiology with impaired healing, such as decubitus ulcer, arterial and/or diabetic foot ulcer, Charcot's foot or malum perforans, may be present in the same patient but shall not be selected as targets for the present study. 6. Vascular reconstruction or angioplasty less than 3 months ago 7. Clinically significant abnormal values in clinical chemistry o Advanced renal failure (Creatinine >2mg%) o Severe hepatic disease (3 times above upper normal limit) o Uncontrolled Diabetes mellitus (HbA1c >9%). o Significant anaemia (Hb 45.0 kg/m² 10. Patient is not ambulatory 11. Concurrent illness or a condition that may interfere with wound healing other than those mentioned in the inclusion criteria (e. g. carcinoma, haematological disease, vasculitis, connective tissue disease, alcohol neuropathy) 12. Previous radiation of the region of the target wounds selected for the study 13. Exposure of any systemic immunosuppressive or cytostatic therapy during the previous 6 months days prior to the study 14. Severe psychiatric or neurological disorder 15. Incapability of giving informed legal consent 16. Unsuitable circumference of ancle and/or wade (as defined in section 17.3) preventing adequate compression treatment 17. Co-worker, student, relative or spouse of the investigator 18. Previous participation in the study 19. Participation in another experimental clinical study during the previous 30 days prior to the present study 20. Current drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the efficacy and safety of the new wound healing solution DPOCl for the treatment of venous leg ulcers in comparison to 0.9 % saline solution;Secondary Objective: not applicable;Primary end point(s): 1) Percentage of patients achieving complete wound closure 2) Percentage of patients achieving at least >50% wound closure 3) Overall % reduction of wound size at the end of treatment 4) Time to complete wound closure 4) Time to >50% wound closure 5) Subjective symptom relief 6) reduction od wound size at week 4,8,12 , and 16 weeks ;Timepoint(s) of evaluation of this end point: time of complete wound closure end of treatment after 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): see points 4-6 above;Timepoint(s) of evaluation of this end point: after 16, 12 ,8 and 4 weeks | — |
Countries
Germany, Latvia, Lithuania, Ukraine
Contacts
Public ContactChief Medical Officer
DermaTools Biotech GmbH
Outcome results
None listed