A trial to assess the safety and tolerability of EBC-1013 Gel in participants with venous leg ulcers.
- Conditions
- Venous Leg UlcersSkin - Dermatological conditionsSkin - Other skin conditions
- Registration Number
- ACTRN12624000544572
- Lead Sponsor
- QBiotics Group Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Male or female patient aged 18 years and above at screening with a Body Mass Index (BMI) of 35 or below.
- Patient with a defined Venous Leg Ulcer (VLU), which has been present for at least
three months but no longer than 48 months at Screening,
- VLU is between 5.0 cm2 and an upper limit of 40.0 cm2 at Screening
- VLU is confirmed as venous in origin by venous doppler ultrasound and an Ankle Brachial Pressure Index (ABPI) > 0.8 to < 1.3 performed at Screening.
- Oedema of the leg with the VLU is assessed by the Investigator as adequately managed with compression therapy for six weeks or more prior to Screening.
- History of non-compliance with standard of care treatment for VLU as evidenced by poorly managed leg oedema as assessed by the Investigator.
- Suspicion of current neoplastic involvement in chronicity of wound.
- Patient has an active malignancy or history of malignancy in the three years prior to screening.
- Significant hepatic or renal impairment
- Rheumatoid arthritis with known vasculitis.
- VLU has exposed tendons, ligaments, muscle or bone.
- VLU is assessed as deteriorating at Screening or has active infection requiring antibiotic treatment.
- Presence of active cellulitis on the leg with the VLU requiring antibiotic treatment.
- Debridement, skin grafts, negative pressure therapy, ultrasound therapy or systemic or topical growth factor therapy applied to the VLU within two weeks before screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method