Performance of the medical device LHAC1 (hyaluronic acid - collagenase) for the management of chronic venous ulcers
- Conditions
- Chronic venous ulcersCirculatory System
- Registration Number
- ISRCTN12579869
- Lead Sponsor
- Fidia Pharmaceutical [Fidia Farmaceutici S.p.A.] (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
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
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< 0.8), measured by Doppler sonography, absent pulses and peripheral arterial disease
4. Subjects using occlusive wound dressings. The elastocompressive bandages are allowed
5. Concomitant use of local antibiotics, hydrogels, hydrocolloids (the administration of oral antibiotics in presence of infection is allowed)
6. Concomitant use of detergents, hexachlorophene, acid solutions, antiseptics containing heavy metal ions (such as mercury, silver, cobalt, magnesium and manganese), or soaks containing metal ions or acidic solutions (such as Burow's aluminium acetate solution)
7. Concomitant use of disinfectants containing quaternary ammonium
8. Subjects with a known hypersensitivity to collagenase or hyaluronic acid
9. Immunocompromised subjects; known seropositivity to human immunodeficiency virus (HIV)
10. Subjects affected by severe renal, dismetabolic or hepatic failure which represents a risk to the subjects
11. Presence of underlying medical conditions that might interfere with study completion, e.g. end-stage malignant disease, unstable diabetes mellitus, aplastic anaemia, sclerodermia, severe obesity (Body Mass Index > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of subjects (%) with complete debridement (final debridement or final visit vs baseline) evaluated by using the following five-points scale:<br>1=100% reduction<br>2= presence of less than 25% of necrotic tissue<br>3= presence of 26% to 50% of necrotic tissue<br>4= presence of 51% to 74% of necrotic tissue<br>5= presence of 75% to 100% of necrotic tissue<br>where the points 1 and 2 were considered a complete debridement rating.<br>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 Outcome Measures
Name Time Method 1. Reduction percentage of necrotic area <br>2. Status of the wound bed (non-necrotic/clean area) and periwound skin <br>3. Overall final judgments