A study to assess the efficacy of maggots as a wound debridement agent for venous leg ulcers under graduated compression bandages

Completed

Conditions: Cardiovascular: Venous ulcers
Circulatory System
Venous ulcers

Registration Number: ISRCTN46226449

Lead Sponsor: Department of Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Inclusion criteria as of 04/09/2007:
1. Patient is at least 18 years of age
2. Ankle Brachial Pressure Index greater than or equal to 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 cm^2 and a maximum of 100 cm^2 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

Previous inclusion criteria:
40 subjects aged over 18 with a venous ulcer

Exclusion Criteria

Exclusion criteria as of 04/09/2007:
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

Please note that previous to this addition there were no exclusion criteria.