None listed
Conditions
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).
Interventions
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. inflammatio
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.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed