Plain English Summary
Background and study aims
Chronic leg ulcers are sores on the leg or foot that have not healed after 4-6 weeks. Symptoms include pain, itching and swelling. People most at risk of developing a chronic leg ulcer include those that are extremely overweight (obese), have problems getting around (mobility problems), sufferers of varicose veins, people who have recently had leg surgery or have suffered a leg injury, and the elderly. One of the steps in treating leg ulcers is wound-bed preparation (WBP) where dead, damaged or infected skin is removed (debridement). Studies have shown that the topical treatment (medication applied to the skin) Bionect Start is an effective dressing for chronic leg ulcers, due to its debridement activity. We want to see whether Bionect Start removes more dead, damaged and infected tissue from the ulcer wound than a placebo (dummy medication). We also want to find out whether the treatment results in less pain, reduces the size of the ulcer, reduces the amount of odour coming from the ulcer, improves the health of the tissue surrounding the ulcer (periwound), makes the patient feel more comfortable, and leads to an overall improvement in the patients quality of life.
Who can participate?
Adults (aged between 18-85 years) with chronic leg ulcers.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 receive the Bionect Start treatment. Those in group 2 receive the placebo treatment. Each treatment is applied to the participants wounds once a day until complete wound debridement has occurred or for a maximum period of 30 days. After treatment, the wounds are dressed with a non-occlusive non- adherent paraffin gauze free of drugs and then covered with a double-layer compression stocking. Each participants visits the trial centre for treatment for up to 5 visits, where the wound is assessed.
What are the possible benefits and risks of participating?
Participants in the Bionect Start group may benefit from a more effective treatment for their chronic leg ulcer. We do not foresee any particular risks for patients taking part in the study apart from an allergy to the ointments used.
Where is the study run from?
Department of Surgery and Vascular Pathology, Istituto Dermopatico dell'immacolata (Italy)
When is the study starting and how long is it expected to run for?
November 2011 to September 2013
Who is funding the study?
Fidia Pharmaceuticals (Fidia Farmaceutici S.p.A.) (Italy)
Who is the main contact?
Nicola Giordan
ngiordan@fidiapharma.it
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RR-37-11-01
Study information
Scientific title
A double blind randomized study to assess the role of Bionect Start for the management of chronic venous ulcers
Acronym
N/A
Study hypothesis
It is hypothesized that Bionect Start ointment has the capacity to improve wound bed preparation due to its selective effect on devitalized tissue. The purpose of the study is to verify this debridement action comparing it to that of a placebo ointment.
Ethics approval
Comitato Etico dellIstituto dermopatico dellImmacolata IRCCS e dellOspedale San Carlo; 19/09/2011; 117/CE/2011
Study design
Double blind randomized placebo controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please contact details below to request patient information sheet
Condition
Venous Ulcers
Intervention
Patients will be divided in 2 arms: arm A patients will be treated daily with Bionect Start plus compression therapy, arm B patients will be treated daily with placebo plus compression therapy
5 visits are scheduled:
Baseline visit: inclusion visit and first treatment
Visit 1 : during study treatment (FU at the center)
Visit 2: during study treatment (FU at the center)
Visit 3: during study treatment (FU at the center)
Visit 4: during study treatment (FU at the center)
Intervention type
Phase
Not Applicable
Drug names
Primary outcome measure
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
The following variables will be evaluated at baseline and at each subsequent visit:
1. Mean of debridement rate measured by digital planimetry system
2. Pain during the day assessed by VAS scale
3. Pain during the night assessed by VAS scale
4. Pain during the change of dressing medication assessed by VAS scale
5. Wound size at each visit. The mean change (%) in wound size will be measured by digital planimetry system
6. Odour
7. Tissue viability
8. Erythema/redness in periwound skin
9. The following will be evaluated at last visit:
10. Investigators global assessment of wound bed
11. Investigators global assessment of dressing comfort
12. Quality of life by EQ-5D will be assessed at baseline visit and final visit
13. For all the duration of the study safety and tolerability will be assessed by recording all AE
Overall trial start date
10/11/2011
Overall trial end date
18/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
110
Participant exclusion criteria
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
Recruitment start date
10/11/2011
Recruitment end date
18/09/2013
Locations
Countries of recruitment
Italy
Trial participating centre
Department of Surgery and Vascular Pathology, Istituto Dermopatico dell'immacolata
Rome
00167
Italy
Sponsor information
Organisation
Fidia Pharmaceuticals (Fidia Farmaceutici S.p.A.) (Italy)
Sponsor details
Via Ponte della Fabbrica 3/A
35031 Abano Terme (PD)
Padova
35031
Italy
-
ngiordan@fidiapharma.it
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Fidia Pharmaceuticals (Fidia Farmaceutici S.p.A.) (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Paper for publication in draft now
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list