The efficacy of maggots as a debridement agent for venous leg ulcers - Maggot therapy for venous leg ulcers
- Conditions
- 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.
- Registration Number
- EUCTR2007-003915-30-GB
- Lead Sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the clinical effectiveness of BioFOAM maggots in the debridement of sloughy venous leg ulcers;Secondary Objective: To assess whether the use of maggots expedites healing when compared to standard treatment (compression bandaging).;<br> 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.<br><br> 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.<br>
- Secondary Outcome Measures
Name Time Method