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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 3 October 2016
Main ID:  EUCTR2014-001001-40-LV
Date of registration: 29/04/2014
Prospective Registration: Yes
Primary sponsor: DermaTools Biotech GmbH
Public title: a clinical study for patients suffering from chronic venous leg ulcers to be treated with a new wound healing solution
Scientific title: A multicentre, double-blind, randomised, controlled phase II/III study to evaluate the efficacy and safety of the new wound healing solution Diperoxochloric acid (DPOCl, DermaPro®) in patients with venous leg ulcer (ulcus cruris) - DPOCl versus isotonic sodium chloride solution in patients with ulcus cruris
Date of first enrolment: 13/06/2014
Target sample size: 160
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001001-40
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Germany Latvia Lithuania Ukraine
Contacts
Name: Chief Medical Officer   
Address:  Eisenacherstrasse 4 63322 Roedermark Germany
Telephone:
Email: m.weissbach@cytotools.de
Affiliation:  DermaTools Biotech GmbH
Name: Chief Medical Officer   
Address:  Eisenacherstrasse 4 63322 Roedermark Germany
Telephone:
Email: m.weissbach@cytotools.de
Affiliation:  DermaTools Biotech GmbH
Key inclusion & exclusion 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:
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 < 10g/dl),
o Albumin <2,5g/dl
8. Severe or uncontrolled heart failure (NYHA class III or IV)
9. BMI > 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Venous leg ulcer (ulcus cruris)
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Intervention(s)

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: Intralesional use

Primary Outcome(s)
Timepoint(s) of evaluation of this end point: time of complete wound closure
end of treatment after 16 weeks
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
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
Secondary Outcome(s)
Secondary end point(s): see points 4-6 above
Timepoint(s) of evaluation of this end point: after 16, 12 ,8 and 4 weeks
Secondary ID(s)
DT-DP-UC-CR-01
Source(s) of Monetary Support
DermaTools Biotech GmbH
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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