E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The purpose of the trial is to evaluate the effectiveness of BioFOAM maggots in achieving rapid debridement of chronic venous leg ulcers. Removal of slough and necrotic tissue from these wounds is essential if the wound is to heal effectively. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the clinical effectiveness of BioFOAM maggots in the debridement of sloughy venous leg ulcers |
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E.2.2 | Secondary objectives of the trial |
To assess whether the use of maggots expedites healing when compared to standard treatment (compression bandaging). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Patient is at least 18 years of age. 2) Ankle Brachial Pressure Index >/= 0.85 N.B. calculations to be made using Doppler ultrasound measurements from both dorsalis pedis and posterior tibial arteries to minimise error (standard procedure). 3) Patient has a venous leg ulcer, located between the knee and ankle (at the level of, and including, the lateral and medial malleoli). The ulcer must be confirmed as of venous origin by venous duplex ultrasound. 4) Patient’s ulcer is a minimum of 4 cm2 and a maximum of 100 cm2 on initial screening. 5) Patient’s ulcer is covered by a minimum of 20% slough calculated using the manual and computer-aided planimetry method). 6) Patient understands and is willing to participate in the clinical study and can comply with the follow-up regime. 7) Patient has read the patient information leaflet and signed the Local Research Ethics Committee approved informed consent form before screening and commencement of trial treatment.
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E.4 | Principal exclusion criteria |
1) Patient’s ulcer should not show exposed blood vessels, tendon, muscle or bone. 2) Patients with a history of a bleeding disorder that, in the opinion of the researcher, would make compliance with the trial protocol medically unsafe. 3) Patients who are unable to understand the aims and objectives of the trial. 4) Patient has any condition(s), which seriously compromises the patient’s ability to complete this study, or has a known history of poor compliance with medical treatment. 5) Patient has an aversion to maggots, despite careful and informative discussion between researcher and patient and explanation of the benefits of maggots
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is the time to debridement of the study ulcer. Successful debridement is defined as minimal slough that does not, in the clinical opinion of the researcher, require the application of a further treatment specifically for debridement.
All participants will be followed up by the research team for up to 12 weeks or until the study ulcer has healed if this is sooner. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard treatment (compression bandages) for venous leg ulcers |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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This is provided in the protocol. The primary end point for each participant is 12 weeks following randomisation and start of treatment or the date the study ulcer heals if this is sooner. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |