Clinical Trial of Maggots for Cleaning Leg Ulcers
- Conditions
- The purpose of the trial is to evaluate the effectiveness of the BioFOAM dressing in achieving rapid debridement of chronic wounds typified by leg ulcers. Removal of slough and necrotic tissue from these wounds is essential if the wound is to heal effectively. Sloughy and/or necrotic ulcers of purely venous or mixed arterial/venous aetiology will be considered.Therapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2007-005775-34-GB
- Lead Sponsor
- ZooBiotic Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 172
People for whom all of the following criteria apply:
- Have a sloughy and/or necrotic leg ulcer (slough and/or necrotic tissue estimated to cover a minimum of 25% of the wound) of purely venous or mixed arterial/venous aetiology that can be identified as the reference ulcer; this ulcer must be at least 5cm away from any other ulcer.
- Have an ulcer with an area of >/= 2 square cm and < 100 square cm.
- Have an ankle brachial pressure index (ABPI) equal to or more than 0.5 where the patient has no concurrent symptoms precluding compression.
- Are aged 18 years or above.
- Are willing and able to give informed written consent.
- People with well controlled diabetes mellitus are eligible (HbA1c equal to or less than 10% measured within the previous 12 weeks). The wound should be on or above the malleoli to ensure it is not a diabetic foot wound.
- People with rheumatoid arthritis are eligible to particpate provided they have ulcers that are deemed to be venous in origin.
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 86
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 86
People who:
- Have previously been entered into the intervention phase of the trial.
- Are women of child bearing potential.
- Are pregnant or lactating women.
- Are allergic to hydrogel dressings or any of their components.
- Have grossly oedematous legs, which in the opinion of the recruiting health care professional would not be suitable for treatment with larval therapy and/or hydrogel.
- Patients on anti-coagulant therapy i.e. Warfarin and Heparin (note that patients on prophylactic low molecular weight Heparin may be included).
- People with diabetes mellitus whose blood sugar is not well controlled (HbA1c greater than 10% as measured within the past 12 weeks).
- Patients with clinical signs of infection on the day of enrolment.
- Patients on antibiotics.
- Patients who have deep wounds with exposed bone, tendon or muscle.
- People for whom particpation would not be in their best interests, in the opinion of the recruiting health professional.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method