None listed
Conditions
Brief summary
This is a multi-centre, clinical trial. A sample size of 40 participants is sought. Up to 58 participants will be recruited to account for an estimated drop out rate of 30%. The study will include patients who have chronic, hard-to-heal, venous leg ulcers and use the following treatment procedure: 1) Cleansing the wound bed using local practices, at dressing change, then topically applying VitroGro ECM and covering with a non-adherent wound dressing. 2) Securing the dressing to the wound with tubifast and compression bandaging Dressings will be changed and the treatment procedure will be repeated once per week for Cohort 1 and twice per week for Cohort 2 when clinical, planimetry and photographic assessments will be made. The effectiveness of the treatment procedure will be evaluated on the basis of a 12 week treatment period. In the case of a wound that has healed before the 12 week end point, the treatment period will be shortened. Additional dressing or bandage changes, outside of the scheduled clinic visits, will be also be documented. The primary end point will be the reduction of ulcer size, or numbers healed at the 12 week point. Secondary end points are; reduction of pain, exudate and smell, condition of wound bed and surrounding skin and patient tolerance to the treatment provided and cost effectiveness.
Interventions
VitroGro ECM is a product that is designed to improve healing of chronic wounds by replacing a degraded extracellular matrix.
VitroGro ECM is a sterile, non-invasive treatment that is biological in origin and applied topically. Participants are allocated based on enrollment number to one of two cohorts on the basis of treatment either once or twice per week for up to 12 weeks or until healed, whichever occurs first.
When applied to the wound bed VitroGro ECM (0.014ug) provides a temporary s
VitroGro ECM is a product that is designed to improve healing of chronic wounds by replacing a degraded extracellular matrix. VitroGro ECM is a sterile, non-invasive treatment that is biological in origin and applied topically. Participants are allocated based on enrollment number to one of two cohorts on the basis of treatment either once or twice per week for up to 12 weeks or until healed, whichever occurs first. When applied to the wound bed VitroGro ECM (0.014ug) provides a temporary scaffold to which the patients wound cells can attach and migrate upon.
Sponsors
Tissue Therapies Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed