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

Phase 1

Conditions: Venous leg ulcer (ulcus cruris)
MedDRA version: 18.0Level: LLTClassification code 10045346Term: Ulcerated varicose veinsSystem Organ Class: 100000004866
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2014-001001-40-LT

Lead Sponsor: DermaTools Biotech GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

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
oAdvanced renal failure (Creatinine >2mg%)
oSevere hepatic disease (3 times above upper normal limit)
oUncontrolled Diabetes mellitus (HbA1c >9%).
oSignificant anaemia (Hb < 10g/dl),
oAlbumin <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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Percentage of complete wound closure;Secondary Objective: Percentage of patients with at least 50% wound reduction<br>Absolute wound reduction<br>Improved subjective symptoms;Primary end point(s): 1) Percentage of patients achieving complete wound closure<br>2) Percentage of patients achieving at least >50% wound closure<br>3) Overall % reduction of wound size at the end of treatment<br>4) Time to complete wound closure<br>4) Time to >50% wound closure<br>5) Subjective symptom relief<br>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<br>end of treatment after 16 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): see points 4-6 above;Timepoint(s) of evaluation of this end point: after 16, 12 ,8 and 4 weeks

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