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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

Plain Language Summary

Simplified for easier understanding

This study investigates 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. It is looking for both men and women, aged 18 to 90 who have 1. Presence of a venous ulcer that is confirmed by a venous duplex scan (performed by an experienced vascular technologist or ultrasonographer) to .... If you are interested, you may need to attend study visits and follow the research team's instructions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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