None listed
Conditions
Brief summary
The purpose of this study is to see if the medication ixekizumab might be used to treat underlying inflammation associated with chronic venous ulcers. The study is for anyone with a chronic venous ulcer that has failed to respond to standard therapy (compression bandaging for four consecutive weeks). 28 patients are required for this trial. 14 patients will receive the treatment medication and 14 will receive the placebo medication. Neither the patients nor the staff will know who is receiving which medication. You will receive injections fortnightly for 12 weeks including continuing with the dressings and compression bandaging that you were being treated with prior to the trial. After the 12 weeks it is hoped that this medication Ixekizumab will have added in a significant reduction in the wound size.
Interventions
Cohorts of patients with chronic venous ulcers (n = 28) will be randomly assigned to treatment and placebo groups, both receiving continuous compression treatment and standard dressing and therapy of wounds.
Ixekizumab or placebo will be injected subcutaneously (prefilled syringe format) in two 80 mg injection at week 0, followed by single 80mg injections at weeks 2, 4, 6, 8, 10 and 12. This corresponds to standard dosing regimen performed in psoriasis.
Standard dressings and compression bandag
Cohorts of patients with chronic venous ulcers (n = 28) will be randomly assigned to treatment and placebo groups, both receiving continuous compression treatment and standard dressing and therapy of wounds. Ixekizumab or placebo will be injected subcutaneously (prefilled syringe format) in two 80 mg injection at week 0, followed by single 80mg injections at weeks 2, 4, 6, 8, 10 and 12. This corresponds to standard dosing regimen performed in psoriasis. Standard dressings and compression bandaging will be removed, re-dressed and re-bandaged at each visit (fortnightly) by the nurse. Each dressing and bandage change will take approximately 30mins to complete. Compression Treatment - bandaging to the leg applying as much compression as is tolerated by the patient. Every patient will have differing degrees of compression. Standard Dressings - Dressings applied to the leg under the compression bandaging. Therapy - If patients are receiving additional therapy such as regular wound cleaning.
Sponsors
The University of Queensland Diamantina Institute
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. Aged 18 years or older. 2. Patients who are willing to read or comprehend and sign a voluntary consent for research 3. Patients with Chronic Venous Ulcers that have failed to respond to Standard Therapy including Compression for 4 weeks
Exclusion criteria
1. Arterial insufficiency: Ankle-Brachial pressure index <0.7 2. Diabetes 3. Pregnancy 4. Crohn’s Disease 5. Ulcerative Colitis 6. Infection or excessive colonization of ulcer in past 2 months 7. Patients whose neutrophil count is not WNL 8. Patients who have active Tuberculosis (positive QFT-G) 9. Patients currently being treated for malignancy 10. Patients with chronic or recurrent candidiasis infection 11. Patients who have inflammatory bowel disease (IBD) 12. Women of childbearing age 13. Any contraindication to therapy 14. Life expectancy of less than 6 months due to chronic illness Any other condition as defined by the investigator which significantly impact the patient’s suitability in this study such as the use of cytotoxic medication, inability to present to study visits due to distance.
Outcome results
None listed