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Clinical Trials/ACTRN12611000132943
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.

Registry
who.int
Start Date
February 4, 2011
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Tissue Therapies Ltd

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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