Multicenter, double-blind, randomized, placebo-controlled clinical trial on the performance and tolerability of Bionect Start (hyaluronic acid sodium salt - collagenase) for the management of chronic venous ulcers
- Conditions
- Venous UlcersSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN71239043
- Lead Sponsor
- Fidia Pharmaceuticals (Fidia Farmaceutici S.p.A.) (Italy)
- Brief Summary
2017 results in https://pubmed.ncbi.nlm.nih.gov/28387882/ (added 17/12/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 113
1. Both sexes, all ethnic backgrounds, both ambulatory and hospitalized Subjects, between 18 and 80 years of age
2. Subjects with a diagnosis of chronic venous ulcers (CEAP classification: C6) with devitalized/fibrinous/slough tissue more than 40% of the lesion. Chronic ulcer is defined as that ulcer not reducing its area of at least 20-40% in 4 weeks of optimum treatment (i.e. compession bandaging/stocking).
3. Subjects who have a venous leg ulcer of at least 6 months duration
4. Subjects who have a target wound which is between 5 cm squared to 30 cm squared in area at the baseline assessment
5. 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 center for all the required visits
6. Subjects who have given their written informed consent in accordance with provisions of pertinent excerpt from the Declaration of Helsinki (revised October 2008) and GCP for medical devices
1. Subjects who have exposed bone, tendon or fascia visible around the target wound
2. Subjects who have an Ankle Brachial Pressure Index lower than 0.8 (ABPI < 0.8) measured by Doppler sonography, absent pulses and peripheral arterial disease
3. Concomitant use of local antibiotics, hydrogels, hydrocolloids (it is allowed the administration of oral antibiotics in presence of infection)
4. 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). Concomitant use of disinfectants containing quaternary ammonium
5. Subjects with a known hypersensitivity to Collagenase or Hyaluronic acid.
6. Immunocompromised Subjects; known seropositivity to HIV virus
7. Subjects affected by severe renal, dismetabolic or hepatic failure which represents a risk to the Subjects; presence of underlying medical conditions that might interfere with study completion, e.g. end-stage malignant disease, unstable diabetes mellitus, aplastic anemia, sclerodermia, severe obesity (Body Mass Index > 35), cachexia and recent burns
8. Participation in any other study involving investigational or marketed products concomitantly or within one month prior to study entrance
9. A history of alcoholism, treatment abuse, psychological or other emotional problems that could invalidate informed consent or limit the Subject compliance with protocol requirements.
10. 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
11. Necessity to have a concomitant therapy with any treatment mentioned in the restrictions
12. 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 Mean of debridement rate (in terms of percentage change of devitalized/fibrinous/slough tissue area) measured by digital planimetry system at Day 15. For patients with a complete debridement occurring before Day 15 will be assigned a debridement value equal to 100%.
- Secondary Outcome Measures
Name Time Method