Clinical Trials Register

Summary
EudraCT Number:	2014-001001-40
Sponsor's Protocol Code Number:	DT-DP-UC-CR-01
National Competent Authority:	Latvia - SAM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2014-04-29
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Latvia - SAM

A.2

EudraCT number

2014-001001-40

A.3

Full title of the trial

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)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

a clinical study for patients suffering from chronic venous leg ulcers to be treated with a new wound healing solution

A.3.2

Name or abbreviated title of the trial where available

DPOCl versus isotonic sodium chloride solution in patients with ulcus cruris

A.4.1

Sponsor's protocol code number

DT-DP-UC-CR-01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	DermaTools Biotech GmbH
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	DermaTools Biotech GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	DermaTools Biotech GmbH
B.5.2	Functional name of contact point	Chief Medical Officer
B.5.3	Address:
B.5.3.1	Street Address	Eisenacherstrasse 4
B.5.3.2	Town/ city	Roedermark
B.5.3.3	Post code	63322
B.5.3.4	Country	Germany
B.5.6	E-mail	m.weissbach@cytotools.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	DermaPro
D.3.2	Product code	DPOCl
D.3.4	Pharmaceutical form	Concentrate for cutaneous solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intralesional use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Cutaneous solution
D.8.4	Route of administration of the placebo	Intralesional use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Venous leg ulcer (ulcus cruris)

E.1.1.1

Medical condition in easily understood language

a chronic non healing wound located below the knee

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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

E.2.2

Secondary objectives of the trial

not applicable

E.2.3

Trial contains a sub-study

E.3

Principal 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.

E.4

Principal 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

E.5 End points

E.5.1

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

E.5.1.1

Timepoint(s) of evaluation of this end point

time of complete wound closure
end of treatment after 16 weeks

E.5.2

Secondary end point(s)

see points 4-6 above

E.5.2.1

Timepoint(s) of evaluation of this end point

after 16, 12 ,8 and 4 weeks

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Germany

Latvia

Lithuania

Ukraine

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The trial is individually terminated either at the end of treatment period (week 16) or when wound closure isachieved, what ever comes first.
Patients not showing wound improvement after 4 weeks of treatment will be excluded from the trial.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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:

120

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

120

F.4.2.2

In the whole clinical trial

160

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

For each patient, where the wound is completely closed no further treatment is required. Patients, where the treatment was not fully successful at the end of the study, appropriate alternative treatment will be proposed by the investigator the trial partipant

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Clinical Research Foundation EEU
G.4.3.4	Network Country	Latvia
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	Syne Qua Non Ltd
G.4.3.4	Network Country	United Kingdom

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-06-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-05-20

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2016-05-15

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