Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000060347
Ethics application status
Approved
Date submitted
24/01/2008
Date registered
31/01/2008
Date last updated
6/03/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase II/III study to evaluate the efficacy and safety of MD 920 (Gibberellic Acid and Salt 1:1) in patients with hard to heal chronic venous ulceration
Scientific title
A Phase IIb/III, Randomised, Multi Centre Study to Evaluate the Efficacy and Safety of MD 920 (Gibberellic Acid and Salt 1:1) Adsorbed to a Non Adhesive Dressing Used with Standard 4 Layered Compression Therapy Compared with Standard 4 Layered Compression Therapy alone in Participants with Hard to Heal Chronic Venous Ulceration
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
venous leg ulcers 2757 0
Condition category
Condition code
Cardiovascular 2884 2884 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gibberellic Acid and Salt 1:1 knowna as MD920 adsorbed onto a non-adhesive wound contact layer dressing in the amount of 0.5mg/cm2.This equates to a total administered dose of 50mg of MD920. This wound contact layer will be applied weekly to the ulcer.
Multi-layer compression bandage will be changed weekly.
The treatment period will consist of 12 weekly applications of MD920 and compression bandage changes.
Intervention code [1] 2496 0
Treatment: Drugs
Comparator / control treatment
compression bandage alone changed weekly
Control group
Active

Outcomes
Primary outcome [1] 3769 0
To assess the healing efficacy and safety of MD 920 (gibberellic acid and salt 1:1) applied topically to target venous leg ulcer as evidenced by the percentage reduction in wound size
Timepoint [1] 3769 0
from baseline compared to week 12 following randomisation.
Secondary outcome [1] 6360 0
To assess the early healing efficacy of MD 920 (gibberellic acid and salt 1:1) applied topically to venous leg ulcers as evidenced by the proportion of participants who have complete healing
Timepoint [1] 6360 0
end of treatment period (week12 following randomisation)
Secondary outcome [2] 6361 0
Quality of Life measures (SF 36 and Cardiff Wound Impact Schedule).
Timepoint [2] 6361 0
baseline, at end of treatment and at 3 month follow up (week12 following randomisation)
Secondary outcome [3] 6362 0
Incidence of treatment related adverse events.
Timepoint [3] 6362 0
end of treatment period (week12 following randomisation)
Secondary outcome [4] 6363 0
Measure reliability and acceptability (withdrawals).
Timepoint [4] 6363 0
end of treatment period(week12 following randomisation)
Secondary outcome [5] 6364 0
Incidence of adverse effects and serious adverse events.
Timepoint [5] 6364 0
end of treatment period(week12 following randomisation)
Secondary outcome [6] 6365 0
Evaluate self-reported compliance of compression bandage.
Timepoint [6] 6365 0
end of treatment period(week12 following randomisation)
Secondary outcome [7] 6366 0
Economic evaluation
Timepoint [7] 6366 0
end of treatment period(week12 following randomisation)
Secondary outcome [8] 6367 0
Incidence of recurrence rates
Timepoint [8] 6367 0
end of treatment period (week 12 following randomisation)

Eligibility
Key inclusion criteria
Male and female study participants who meet all of the following criteria can be entered into the study:
1. Presence of a venous ulcer that is confirmed by a venous duplex scan (performed by an experienced vascular technologist or ultrasonographer) to be the result of chronic venous insufficiency.
2. Aged over 18 years.
3. Present with clinical evidence of chronic venous insufficiency and chronic venous ulceration as evidenced by one or more of the following:
i. lower limb pigmentation,
ii. varicose eczema,
iii. lipodermatosclerosis,
iv. varicose veins.
4. Chronic venous leg ulcer (target ulcer) that
i. Has been present for at least 6 weeks but no longer than 52 weeks,
ii. is of an area equal to or greater than 3 cm2 but less than or equal to 20 cm2 as measured by digital planimetry techniques,
iii. has no evidence of malignancy,
iv. has no other aetiological factors, e.g. neuropathic, arterial, or vasculitic.
5. Clear of cardiac abnormalities evidenced by a normal ECG reading.
6. Ankle Brachial Pressure index of equal or greater than 0.8 mmHg.
7. Ankle circumference of greater than 18 cm and less than 25 cm (Profore® bandaging guidelines).
8. Mobile, and able to return for required treatments and study evaluations without undue hardship.
9. Able to give Informed Consent. A reasonable attempt will be made to provide a translator to those who are unable to speak and read English fluently.
10. Able to understand and comply with the requirements of the trial.
11. Female study participants of child bearing potential who have a negative pregnancy test.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Study participants who meet any of the following criteria will not be eligible for participation in this study:
1. Unable or unwilling to wear compression bandage as directed.
2. Allergy to any of the trial products used.
3. Prior adverse reaction to compression products.
4. Immobility.
5. Ankle circumference < 18 cm or > 25 cm (Profore® bandaging guidelines).
6. Participation in any other clinical trial or exposure to an investigational drug within 30 days of study enrolment.
7. Evidence of severe liver disease, cardiac disease or chronic pulmonary disease.
8. History of immunologically mediated disease (for example inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus).
9. Medical condition likely to require systemic corticosteroids during the study period.
10. Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness).
11. Presence of malignant disease or documented history of malignant disease excluding dermatological malignancy (study participants with a five year disease free interval may be considered at the discretion of the Investigator).
12. Clinically documented thrombo-phlebitis or suspected deep vein thrombosis.
13. Abnormal laboratory results deemed clinically significant by the Investigator.
14. Unable or unwilling to attend clinic for weekly treatment
15. Participation in this trial previously and/or who dropped out or were withdrawn

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To decrease bias and confounders the decision to accept or reject a participant will be made using inclusion and exclusion criteria. Informed consent will be obtained by participant without knowing the next assignment in the sequence. Independent clinicians will apply compression bandage systems according to the computer generated list allocation. The code will be revealed to the researchers once the recruitment, data collection and wound measurement analysis are completed. The allocation list will be stored with CRO.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised to receive either control or intervention group using a central computer generated random number generated by Trident Clinical Research. The randomization code will be sent to the Investigator (or designee) who will prepare treatments according to the randomisation code. Randomisation will be stratified by site and wound size =10cm2 or >10cm2.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
158
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 559 0
3004

Funding & Sponsors
Funding source category [1] 3012 0
Commercial sector/Industry
Name [1] 3012 0
AUS BIO Ltd
Country [1] 3012 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
AUS BIO Ltd
Address
Unit 1/27 Normanby Road
NottingHill 3168
Country
Australia
Secondary sponsor category [1] 2715 0
University
Name [1] 2715 0
Monash University
Address [1] 2715 0
Dept. Epidemiology and Preventative Medicine
Burnet Building, Alfred Hospital
Commercial road Melbourne 3004
Country [1] 2715 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4969 0
The Alfred Research and Ethics Unit
Ethics committee address [1] 4969 0
Ethics committee country [1] 4969 0
Australia
Date submitted for ethics approval [1] 4969 0
28/11/2007
Approval date [1] 4969 0
Ethics approval number [1] 4969 0
Ethics committee name [2] 4993 0
Ethics committee address [2] 4993 0
Ethics committee country [2] 4993 0
Date submitted for ethics approval [2] 4993 0
28/11/2008
Approval date [2] 4993 0
Ethics approval number [2] 4993 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28324 0
Address 28324 0
Country 28324 0
Phone 28324 0
Fax 28324 0
Email 28324 0
Contact person for public queries
Name 11481 0
Carolina Weller
Address 11481 0
Dept. Epidemiology and Preventative Medicine
Burnet Building, Alfred Hospital
Commercial road Melbourne 3004
Country 11481 0
Australia
Phone 11481 0
03 99030623
Fax 11481 0
Email 11481 0
[email protected]
Contact person for scientific queries
Name 2409 0
Dr Peter Jenkins
Address 2409 0
Unit 1/27 Normanby Road
NottingHill 3168
Country 2409 0
Australia
Phone 2409 0
03 9562 6844
Fax 2409 0
Email 2409 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.