Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000568718
Ethics application status
Approved
Date submitted
15/04/2013
Date registered
20/05/2013
Date last updated
25/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Hypersensitivity Testing of Topical Allopurinol on Venous Leg Ulcers
Scientific title
A Randomised Double Blinded Placebo Controlled Hypersensitivity Testing (Phase 1) of Topical Allopurinol (20mg of Allopurinol in Solosite Wound Gel) Compared with a Placebo Treatment (Solosite Wound Gel) on 20 Patients with a Venous Leg Ulcer
Secondary ID [1] 282337 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Leg Ulcers 288885 0
Condition category
Condition code
Skin 289228 289228 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Allopurinol (20mg) will be delivered topically in 5g of Smith and Nephew Solosite Wound gel. The topical allopurinol will be applied once for 15 minutes. After 15 minutes the topical allopurinol will be immediately washed off with warm water.
The purpose of the is study is to determine the safety of allopurinol. Study participants will be assessed prior to administration of topical allopurinol, then after 15 minutes and one week of exposure to the treatment for adverse effects e.g. inflammation, discomfort, apin and pruritus.
Intervention code [1] 286953 0
Treatment: Drugs
Comparator / control treatment
Placebo Group - 5g of Smith and Nephew Solosite Wound Gel applied once topically on the leg ulcer for 15 minutes. After 15 minutes the wound gel will be immediately washed off with warm water.
Control group
Placebo

Outcomes
Primary outcome [1] 289343 0
The primary outcome of this study is to determine the safety of topical allopurinol compared to the placebo treatment for study participants with venous leg ulcer. A good outcome will be measured by the lack of adverse effects at the completion of the study. These adverse effects include indicators such as inflammation, pain, discomfort and pruritus. These side effects are all temporary changes and will subside after cessation of treatment.
Timepoint [1] 289343 0
The primary time point is 15 minutes after application and a one week follow up after the administration of topical allopurinol.
Secondary outcome [1] 302284 0
The study will also collect Quality of Life Data measured using Spitzer’s Quality of life scale
Timepoint [1] 302284 0
The secondary time point will be collected at the beginning of the study. This outcome will be assessed prior to the allopurinol treatment i.e at baseline.
Secondary outcome [2] 302834 0
The study will also collect depression data using the Geriatric Depression Scale and the Philadelphia Geriatric Centre Morale Scale. This outcome will be assessed prior to the allopurinol treatment i.e at baseline.
Timepoint [2] 302834 0
The secondary time point will be collected at the beginning of the study.
Secondary outcome [3] 302836 0
Pain measures will also be collected using the Rand Medical Outcomes Study Pain Measures.
Timepoint [3] 302836 0
The secondary time point will be collected at the beginning of the study (prior and after allopurinol application) and at the end of the one week data collection period in the study.

Eligibility
Key inclusion criteria
1. Have leg ulcers of primarily venous aetiology.
2. Ankle Brachial Pressure Index 'greater than or equal to' 0.8 and < 1.3.
3. Agree to comply with all study procedures.
4. If more than one ulcer is present, a target ulcer will be identified for the purpose of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with ulcers of non-venous origin
2. Patients with allopurinol contraindications including renal or hepatic impairment
3. Ankle Brachial Pressure Index <0.8 or 'greater than or equal to' 1.3
4. Presence of clinical signs of infection
5. Patients receiving treatment as a hospital in-patient
6. Patients prescribed allopurinol or other gout-related medication

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)
All study participants presenting to the QUT Wound Healing Community Outreach Service with a venous leg ulcer and fitting the inclusion and exclusion criteria will be invited to participate in the study. After potential participants are identified by the clinician in charge, the Research Assistant will approach the study participant to invite them to participate and give them an information and consent package. The study will be explained and written consent obtained from potential study participants. Following recruitment and securing of consent, study participants will be assigned a unique trial screening number consisting of their initials and a 3-digit number. The Research Assistant will collect baseline data from the study participant’s records and give the study participant a questionnaire to fill in. All data will be recorded in the study participant’s case report form (CRF). Study participants will then receive 15 minute exposure of topical allopurinol in SoloSite Wound Gel or the placebo treatment (SoloSite Wound Gel). The treatment will subsequently be washed off with warm water. Ulcer assessment data and hypersensitivity data will be collected by the on-site research assistant after the application of the treatment as described above. Study participants will receive standard best practice treatment for their ulcer and asked to return to the study wound clinic at the QUT WHCOS a week later to determine their response to topical allopurinol application.

A random allocation sequence will be generated by the Mater Health Services Team prior to commencement of recruitment. The research team will be blinded to the study participants treatment group. Sealed “code break” envelopes will be held at the Wound Healing Community Outreach Service and with the Principal Investigator . The code will be broken by the Investigator, Clinician (or nominee) only if the information is required for the urgent and immediate treatment of the study participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Data analysis
Descriptive analysis will be undertaken of the primary outcome, the number of any hypersensitivity or ADRs in each group. Differences between the two groups will be tested with Chi-squared tests and Mann-Whitney U tests looking at the type and number of any ADRs.
Secondary Outcomes:
Differences between groups in Quality of Life and Pain measures will be analysed using t-tests.

Allopurinol is commonly used orally for the treatment of gout. Therefore, the pharmacokinetics and pharmacodynamics have already known. The purpose of this trial is to determine the safety of the treatment. This preliminary trial is unlikely to improve healing in these patients. Therefore, only a minimum number of patients, i.e. 20 patients, were chosen in order to determine whether to progress this topical formulation further.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/06/2013
Actual
5/08/2013
Date of last participant enrolment
Anticipated
9/12/2013
Actual
29/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 6695 0
4059 - Kelvin Grove

Funding & Sponsors
Funding source category [1] 287095 0
University
Name [1] 287095 0
Queensland University of Technology
Institute of Health and Biomedical Innovation
Country [1] 287095 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
GPO Box 2434
Brisbane, QLD 4001
Country
Australia
Secondary sponsor category [1] 285872 0
None
Name [1] 285872 0
Address [1] 285872 0
Country [1] 285872 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289110 0
Queensland University of Technology University Research Ethics Committe
Ethics committee address [1] 289110 0
Level 4, 80 Musk Avenue,
Kelvin Grove, QLD 4059
Ethics committee country [1] 289110 0
Australia
Date submitted for ethics approval [1] 289110 0
20/11/2012
Approval date [1] 289110 0
26/02/2013
Ethics approval number [1] 289110 0
EC00171

Summary
Brief summary
The primary objective of this randomised, double-blind, placebo-controlled research study is to determine the safety of topical allopurinol (20mg of allopurinol in SoloSite Wound Gel, Smith and Nephew for 15 minutes) compared with a placebo treatment (SoloSite Wound Gel, Smith and Nephew) for study participants with venous leg ulcers, with a good outcome measured by the lack of adverse effects at the completion of the study (i.e., one week after administration of topical allopurinol).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39294 0
Prof Helen Edwards
Address 39294 0
Queensland University of Technology
School of Nursing
Level 3, B Wing, O Block
Victoria Park Road
Kelvin Grove QLD 4059
Country 39294 0
Australia
Phone 39294 0
+ 61 7 31383844
Fax 39294 0
+6173138 5895
Email 39294 0
[email protected]
Contact person for public queries
Name 39295 0
Dr Melissa Fernandez
Address 39295 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Avenue,
Kelvin Grove, QLD 4059
Country 39295 0
Australia
Phone 39295 0
+61 7 31386190
Fax 39295 0
+61731386030
Email 39295 0
[email protected]
Contact person for scientific queries
Name 39296 0
Dr Melissa Fernandez
Address 39296 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Avenue,
Kelvin Grove, QLD 4059
Country 39296 0
Australia
Phone 39296 0
+61 7 31386190
Fax 39296 0
+61731386030
Email 39296 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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