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

Tissue Therapies Ltd0 个研究点目标入组 58 人开始时间: 2011年2月4日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Tissue Therapies Ltd