Condition category
Skin and Connective Tissue Diseases
Date applied
23/10/2014
Date assigned
09/12/2014
Last edited
15/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Giorgio Guarnera

ORCID ID

Contact details

Dipartimento di Chirurgia e Patologia Vascolare dell’Istituto Dermopatico dell’Immacolata di Roma
Via Monti di Creta 104
Rome
00167
Italy

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 dell’Istituto dermopatico dell’Immacolata IRCCS e dell’Ospedale 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 measures

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. Investigator’s global assessment of wound bed
11. Investigator’s 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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes