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TerminatedPhase 2Phase 3ACTRN12608000060347

A phase II/III study to evaluate the efficacy and safety of MD 920 (Gibberellic Acid and Salt 1:1) in patients with hard to heal chronic venous ulceration

A Phase IIb/III, Randomised, Multi Centre Study to Evaluate the Efficacy and Safety of MD 920 (Gibberellic Acid and Salt 1:1) Adsorbed to a Non Adhesive Dressing Used with Standard 4 Layered Compression Therapy Compared with Standard 4 Layered Compression Therapy alone in Participants with Hard to Heal Chronic Venous Ulceration

Sponsor

AUS BIO Ltd

Enrollment

158 participants

Start Date

Mar 1, 2008

Study Type

Interventional

Conditions

venous leg ulcers

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Inclusion Criteria20

  • Male and female study participants who meet all of the following criteria can be entered into the study:
  • 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.
  • Aged over 18 years.
  • 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.
  • 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.
  • Clear of cardiac abnormalities evidenced by a normal ECG reading.
  • Ankle Brachial Pressure index of equal or greater than 0.8 mmHg.
  • Ankle circumference of greater than 18 cm and less than 25 cm (Profore® bandaging guidelines).
  • Mobile, and able to return for required treatments and study evaluations without undue hardship.
  • 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.
  • Able to understand and comply with the requirements of the trial.
  • Female study participants of child bearing potential who have a negative pregnancy test.

Exclusion Criteria16

  • Study participants who meet any of the following criteria will not be eligible for participation in this study:
  • Unable or unwilling to wear compression bandage as directed.
  • Allergy to any of the trial products used.
  • Prior adverse reaction to compression products.
  • Immobility.
  • Ankle circumference < 18 cm or > 25 cm (Profore® bandaging guidelines).
  • Participation in any other clinical trial or exposure to an investigational drug within 30 days of study enrolment.
  • Evidence of severe liver disease, cardiac disease or chronic pulmonary disease.
  • History of immunologically mediated disease (for example inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus).
  • Medical condition likely to require systemic corticosteroids during the study period.
  • Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness).
  • 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).
  • Clinically documented thrombo-phlebitis or suspected deep vein thrombosis.
  • Abnormal laboratory results deemed clinically significant by the Investigator.
  • Unable or unwilling to attend clinic for weekly treatment
  • Participation in this trial previously and/or who dropped out or were withdrawn

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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 woun

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.

Locations(1)

Australia

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ACTRN12608000060347

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