ACTRN12611000132943
Recruiting
未知
Clinical trial on the safety and effectiveness of Tissue Therapies extracellular matrix on healing of venous leg ulcers
Tissue Therapies Ltd0 sites58 target enrollmentFebruary 4, 2011
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Venous Leg Ulcers
- Sponsor
- Tissue Therapies Ltd
- Enrollment
- 58
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females aged greater than or equal to 18 who are able to give informed consent
- •Patients with a chronic venous leg ulcer at any location below the knee joint (CVI grade C6 according to CEAP classification)
- •Venous leg ulcer present for at least 4 weeks
- •Surface area of the target ulcer greater than or equal to 2cm2 and \<30cm2 with the largest length not being \>10cm
- •ABPI greater than or equal to 0\.7
Exclusion Criteria
- •Age below 18 years
- •Unable to give informed consent
- •Females of child bearing potential who are not willing to use a method of highly effective contraception during the entire study
- •Pregnant or breast feeding women
- •On enrolment, clinical infection, or use of antiseptics or antibiotics for wound infection.
- •Participation in other wound research trials within the past 1 month
- •Sensitivity to any of the components of VitroGro or dressing material
- •Intolerance to compression therapy
- •Active osteomyelitis in the ulceration area
- •Active rheumatoid or collagen disease of blood vessels treated with corticosteroids
Outcomes
Primary Outcomes
Not specified
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