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Trial registered on ANZCTR


Registration number
ACTRN12616001292460
Ethics application status
Approved
Date submitted
12/09/2016
Date registered
14/09/2016
Date last updated
1/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An exploratory clinical trial of Autologous Platelet Gel (APG) in adults with Venous Leg Ulcers (VLU).
Scientific title
An exploratory clinical trial of Autologous Platelet Gel (APG) in adults with Venous Leg Ulcers (VLU).
Secondary ID [1] 290133 0
Nil known
Universal Trial Number (UTN)
U1111-1187-5181
Trial acronym
APGiVLU (Autologous Platelet Gel in Venous Leg Ulcers)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Leg Ulcer 300251 0
Condition category
Condition code
Cardiovascular 300115 300115 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 300116 300116 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Autologus Platelet Gel applied to target ulcer in addition to standard best practice compression therapy.
Magellan APG kits will be used for the preparation of the APG treatment. A portion of the patient's blood will be placed in the kit that is linked to a centrifuge which will add fibrin and be set to spin the blood to develop the gel. The Wound Clinic Nurse will draw 60 mls of blood from participants to develop the APG (50 mls) and to send to lab for analysis (10 mls). The APG will be prepared as per standard operating procedure. The APG will take 20 – 30 minutes to prepare. During this time the participant will remain on a bed in the wound clinic. The gel preparation can either be placed or sprayed on to the VLU depending on depth of wound. The gel will be applied once. All participants will be treated with standard best practice wound dressing and compression therapy. Compression type will be delegated by the clinician after discussion with the patient. Participants will be informed that the compression bandage must not be removed during the treatment period.
Compression bandage must not be removed during week one following gel application,
One week after gel application, compression will be removed by study nurse; the ulcer assessed and compression replaced once weekly until ulcer healed or until 12 weeks.


Intervention code [1] 295885 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299599 0
Complete healing of target ulcer. Healing is defined as 100% epithelialisation with no exudate which will be assesed by direct observation by the study nurse. A digital photo will be taken for DCF documentation.
Timepoint [1] 299599 0
12 weeks from application of APG. The ulcer will be assessed at Baseline and every 4 weeks after APG application until healed or 12 weeks whichever comes first. The ulcer outline will be traced on acetate grids and ulcer area calculated. The visit at which complete healing is obsereved will be recorded.
Secondary outcome [1] 327656 0
The rate of ulcer recurrence over 3 months after healing
Timepoint [1] 327656 0
Healed participants before 12 weeks or at 12 weeks will be assessed at 3 months after healing for recurrence by the Study Nurse or by medical record review.

Eligibility
Key inclusion criteria
Eligible participants will be aged over 18 years and have a chronic VLU (target ulcer) that has been present for more than 4 weeks with no improvement. Participants must have an ABPI greater than or equal to 0.7 mmHg to exclude significant arterial insufficiency. The eligible target ulcer will have an area greater than or equal to 1 cm2 to less than or equal to 40 cm2 as measured by acetate tracing grid techniques (largest ulcer on limb and separated from other ulcers by at least 1 cm). If more than one leg ulcer is present, the largest ulcer will be treated.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who have severe liver, cardiac or pulmonary disease or known current malignancy will be excluded.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
No sample size was calculated as this is a pilot, proof of concept study. Twenty patients will be invited to participate in the study.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The study did not proceed due to difficulty obtaining the planned APG treatment kits.
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6653 0
Knox Private Hospital - Wantirna
Recruitment postcode(s) [1] 14278 0
3152 - Wantirna

Funding & Sponsors
Funding source category [1] 294508 0
Commercial sector/Industry
Name [1] 294508 0
Cellplex Pty Ltd
Address [1] 294508 0
16 - 18 Hydrive Close, Dandenong South VIC 3175
Country [1] 294508 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Level 6, The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 293372 0
None
Name [1] 293372 0
Address [1] 293372 0
Country [1] 293372 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295940 0
Monash University HREC
Ethics committee address [1] 295940 0
First Floor, Room 111
Chancellery Building E
24 Sports Walk
Monash Research Office
Clayton Campus
Monash University VIC 3800
Ethics committee country [1] 295940 0
Australia
Date submitted for ethics approval [1] 295940 0
31/08/2016
Approval date [1] 295940 0
05/10/2016
Ethics approval number [1] 295940 0
2016-0438

Summary
Brief summary
Chronic venous leg ulcers are an extremely common and costly problem across the globe. The burden is expected to rise with an ageing population and the growing epidemic of diabetes and obesity. This will increase the therapeutic challenge for treating clinicians. Standard best practice treatment is compression of the lower leg by bandaging to reduce hydrostatic pressure in the leg. Healing rates vary widely and even after two years of compression therapy up to 50% of all chronic VLUs remain unhealed as patient adherence to compression therapy is a continuing challenge, as is best practice management of people with VLUs in the community. Autologous Platelet Gel (APG) together with compression appears to be a promising new intervention for VLU healing. While there is encouraging data from in vitro, animal and clinical studies, strong evidence for its effectiveness from high quality randomised controlled trials is currently lacking. We propose a pilot clinical trial to determine the efficacy, safety and cost-effectiveness of APG gel as an adjunct to compression therapy in healing venous ulcers. We will also assess ulcer recurrence rate of venous ulcers within 3 months of healing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68982 0
Dr Carolina Weller
Address 68982 0
Department of Epidemiology and Preventive Medicine
Monash University
The Alfred Centre, Level 6
99 Commercial Road
Melbourne Vic 3004
Country 68982 0
Australia
Phone 68982 0
+61 3 9903 0623
Fax 68982 0
+61 3 9903 0828
Email 68982 0
carolina.weller@monash.edu
Contact person for public queries
Name 68983 0
Dr Carolina Weller
Address 68983 0
Department of Epidemiology and Preventive Medicine
Monash University
The Alfred Centre, Level 6
99 Commercial Road
Melbourne Vic 3004
Country 68983 0
Australia
Phone 68983 0
+61 3 9903 0623
Fax 68983 0
+61 3 9903 0828
Email 68983 0
carolina.weller@monash.edu
Contact person for scientific queries
Name 68984 0
Dr Carolina Weller
Address 68984 0
Department of Epidemiology and Preventive Medicine
Monash University
The Alfred Centre, Level 6
99 Commercial Road
Melbourne Vic 3004
Country 68984 0
Australia
Phone 68984 0
+61 3 9903 0623
Fax 68984 0
+61 3 9903 0828
Email 68984 0
carolina.weller@monash.edu

No information has been provided regarding IPD availability
Summary results
No Results