None listed
Conditions
Interventions
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.
Sponsors
AUS BIO Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
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.
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
Outcome results
None listed