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Trial registered on ANZCTR


Registration number
ACTRN12611000132943
Ethics application status
Approved
Date submitted
27/01/2011
Date registered
4/02/2011
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical trial on the safety and effectiveness of Tissue Therapies extracellular matrix on healing of venous leg ulcers
Scientific title
Clinical trial on the safety and effectiveness of Tissue Therapies extracellular matrix on healing of venous leg ulcers
Secondary ID [1] 253487 0
VITRO-CARD-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Leg Ulcers 261038 0
Condition category
Condition code
Skin 259176 259176 0 0
Other skin conditions
Cardiovascular 259178 259178 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
VitroGro ECM is a product that is designed to improve healing of chronic wounds by replacing a degraded extracellular matrix.

VitroGro ECM is a sterile, non-invasive treatment that is biological in origin and applied topically. Participants are allocated based on enrollment number to one of two cohorts on the basis of treatment either once or twice per week for up to 12 weeks or until healed, whichever occurs first.

When applied to the wound bed VitroGro ECM (0.014ug) provides a temporary scaffold to which the patients wound cells can attach and migrate upon.
Intervention code [1] 257920 0
Treatment: Devices
Comparator / control treatment
Participants referred to this single arm study will have received and not responded to current best practice wound care. The control aspect of the study is that the only change to the treatment regime is the addition of the test article.

The basis for evaluating treatment once versus twice per week is to establish preliminary cost effectiveness data as well as pilot data which will then inform further study design and numbers needed to show a statistically significant difference.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262028 0
Reduction in wound size or complete healing (wound closure 100% epithelialisation of target ulcer)

Clinical improvement will be measured through computer planimetry assessments of ulcer size of wound tracings on gradated acetate sheets and digital photography.
Timepoint [1] 262028 0
At entry to study, each planned study visit (once per week for Cohort 1 or twice per week for Cohort 2) and at 12 weeks or complete healing, which ever happens sooner.
Secondary outcome [1] 268985 0
Tolerance is assessed by Investigator analysis of the products adverse reactions.

There is a theoretical risk of allergy to VitroGro ECM which is very rare and if you develop an allergy you will have to leave the study and be treated for the allergy which, if it occurs, may present as itching or a mild rash.
Timepoint [1] 268985 0
Participants last visit e.g. at 12 weeks or complete healing, which ever happens sooner.
Secondary outcome [2] 268987 0
Reduction of pain is rated by the subject using a visual analogue scale. Zero (no pain) to 100 (Worst pain).
Timepoint [2] 268987 0
At entry to study, each planned study visit (once per week for Cohort 1 or twice per week for Cohort 2) and at 12 weeks or complete healing, which ever happens sooner.
Secondary outcome [3] 268988 0
Smell is assessed by clinician opinion of wound malodour
Timepoint [3] 268988 0
At entry to study, each planned study visit (once per week for Cohort 1 or twice per week for Cohort 2) and at 12 weeks or complete healing, which ever happens sooner.
Secondary outcome [4] 268989 0
The level of wound exudate is assessed by clinician opinion and recorded as either none, minimal, moderate, heavy or copious.
Timepoint [4] 268989 0
At entry to study, each planned study visit(once per week for Cohort 1 or twice per week for Cohort 2) and at 12 weeks or complete healing, which ever happens sooner.
Secondary outcome [5] 268990 0
The condition of the wound bed is evaluated by clinical assessment taking into account the degree of eschar, slough/necrosis, granulation tissue and islands of epithelium.
Timepoint [5] 268990 0
At entry to study, each planned study visit (once per week for Cohort 1 or twice per week for Cohort 2) and at 12 weeks or complete healing, which ever happens sooner.

Eligibility
Key inclusion criteria
Males and females aged greater than or equal to 18 who are able to give informed consent

Patients with a chronic venous leg ulcer at any location below the knee joint (CVI grade C6 according to CEAP classification)

Venous leg ulcer present for at least 4 weeks

Surface area of the target ulcer greater than or equal to 2cm2 and <30cm2 with the largest length not being >10cm

ABPI greater than or equal to 0.7
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age below 18 years

Unable to give informed consent

Females of child bearing potential who are not willing to use a method of highly effective contraception during the entire study

Pregnant or breast feeding women

On enrolment, clinical infection, or use of antiseptics or antibiotics for wound infection.

Participation in other wound research trials within the past 1 month

Sensitivity to any of the components of VitroGro or dressing material

Intolerance to compression therapy

Active osteomyelitis in the ulceration area

Active rheumatoid or collagen disease of blood vessels treated with corticosteroids

Patients suffering from diseases that result in immune suppression

Chronic diseases that could impact the course of the study (eg. malignancy, TB, AIDS)

Poorly controlled Diabetes (HBA1C > 12%)

Patients who have not received standard compression therapy at time of recruitment for 4 weeks

Patients receiving prohibited medicinal products that are specifically used to treat the venous disease: phlebotropic drugs, drugs with vasorelaxing effect, corticosteroids, antimicrobials or antiseptics.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3592 0
4059
Recruitment postcode(s) [2] 3593 0
6009
Recruitment postcode(s) [3] 3594 0
4032
Recruitment outside Australia
Country [1] 3160 0
United Kingdom
State/province [1] 3160 0
Cardiff, Wales

Funding & Sponsors
Funding source category [1] 258396 0
Commercial sector/Industry
Name [1] 258396 0
Tissue Therapies Ltd
Country [1] 258396 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Tissue Therapies Ltd
Address
Level 6, 60 Musk Avenue
Kelvin Grove, Queensland, 4059
Country
Australia
Secondary sponsor category [1] 257539 0
None
Name [1] 257539 0
Address [1] 257539 0
Country [1] 257539 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This is a multi-centre, clinical trial. A sample size of 40 participants is sought. Up to 58 participants will be recruited to account for an estimated drop out rate of 30%. The study will include patients who have chronic, hard-to-heal, venous leg ulcers and use the following treatment procedure:

1) Cleansing the wound bed using local practices, at dressing change, then topically applying VitroGro ECM and covering with a non-adherent wound dressing.

2) Securing the dressing to the wound with tubifast and compression bandaging


Dressings will be changed and the treatment procedure will be repeated once per week for Cohort 1 and twice per week for Cohort 2 when clinical, planimetry and photographic assessments will be made.

The effectiveness of the treatment procedure will be evaluated on the basis of a 12 week treatment period. In the case of a wound that has healed before the 12 week end point, the treatment period will be shortened. Additional dressing or bandage changes, outside of the scheduled clinic visits, will be also be documented.

The primary end point will be the reduction of ulcer size, or numbers healed at the 12 week point.

Secondary end points are; reduction of pain, exudate and smell, condition of wound bed and surrounding skin and patient tolerance to the treatment provided and cost effectiveness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32138 0
Address 32138 0
Country 32138 0
Phone 32138 0
Fax 32138 0
Email 32138 0
Contact person for public queries
Name 15385 0
Mr Nigel Johnson
Address 15385 0
GPO BOX 1596
Brisbane, Queensland, 4001
Country 15385 0
Australia
Phone 15385 0
+61 7 3839 9938
Fax 15385 0
Email 15385 0
[email protected]
Contact person for scientific queries
Name 6313 0
Mr Nigel Johnson
Address 6313 0
GPO BOX 1596
Brisbane, Queensland, 4001
Country 6313 0
Australia
Phone 6313 0
+61 7 3839 9938
Fax 6313 0
Email 6313 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.