Chronic venous ulcers Circulatory System
Conditions
Interventions
A layer of about 2 mm thickness of LHAC1 (HA-Collagenase) was applied on the wound bed once a day.
Treatment continued until complete wound debridement or for a maximum period of 20 days. Prior to app
Sponsors
Fidia Pharmaceutical [Fidia Farmaceutici S.p.A.] (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both sexes, all ethnic backgrounds, both ambulatory and hospitalized 2. Subjects between 18 and 80 years of age 3. Subjects with a diagnosis of chronic venous ulcers (CEAP classification: C6) with areas (or scattered areas) of necrosis (non-viable soft tissue/slough) more than 40% 4. Subjects who have a venous leg ulcer of at least 6 months duration 5. Subjects who have a target wound which is between 2 cm squared to 25 cm squared in area at the baseline assessment 6. Subjects, who are, in the opinion of the Investigator, able to understand this study, cooperate with the study procedures and are willing to return to the centre for all the required visits 7. Subjects who have given their written informed consent in accordance with provisions of pertinent excerpt from the Declaration of Helsinki (revised October 2008) and the Romanian laws
Exclusion criteria
Exclusion criteria: 1. Subjects with venous leg ulcer with presence of black eschar 2. Subjects who have exposed bone, tendon or fascia visible around the target wound 3. Subjects who have an Ankle Brachial Pressure Index lower than 0.8 (ABPI/ABI 35), cachexia and recent burns 12. Participation in any other study involving investigational or marketed products concomitantly or within one month prior to study entrance 13. A history of alcoholism, treatment abuse, psychological or other emotional problems that could invalidate informed consent or limit the subject's compliance with protocol requirements 14. Females who are pregnant, lactating or who have not reached menopause and are not abstinent or practising an acceptable means of birth control as determined by the Investigator for the duration of the study 15. Necessity to have a concomitant therapy with any treatment mentioned in the restrictions 16. Subjects unlikely to be compliant/cooperative during the study, in the judgment of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects (%) with complete debridement (final debridement or final visit vs baseline) evaluated by using the following five-points scale: 1=100% reduction 2= presence of less than 25% of necrotic tissue 3= presence of 26% to 50% of necrotic tissue 4= presence of 51% to 74% of necrotic tissue 5= presence of 75% to 100% of necrotic tissue where the points 1 and 2 were considered a complete debridement rating. This scale was used for the final data analysis and on the basis of measurements obtained during the trial by tracing the wound necrotic area by grid. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction percentage of necrotic area 2. Status of the wound bed (non-necrotic/clean area) and periwound skin 3. Overall final judgments | — |
Countries
Romania
Outcome results
None listed