Clinical trial on the safety and effectiveness of Tissue Therapies extracellular matrix on healing of venous leg ulcers

Not Applicable

Recruiting

• Conditions: Venous Leg Ulcers; Skin - Other skin conditions; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12611000132943
• Lead Sponsor: Tissue Therapies Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 58

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

Patients suffering from diseases that result in immune suppression

Chronic diseases that could impact the course of the study (eg. malignancy, TB, AIDS)

Poorly controlled Diabetes (HBA1C > 12%)

Patients who have not received standard compression therapy at time of recruitment for 4 weeks

Patients receiving prohibited medicinal products that are specifically used to treat the venous disease: phlebotropic drugs, drugs with vasorelaxing effect, corticosteroids, antimicrobials or antiseptics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in wound size or complete healing (wound closure 100% epithelialisation of target ulcer)<br><br>Clinical improvement will be measured through computer planimetry assessments of ulcer size of wound tracings on gradated acetate sheets and digital photography.[At entry to study, each planned study visit (once per week for Cohort 1 or twice per week for Cohort 2) and at 12 weeks or complete healing, which ever happens sooner.]