Cardiovascular: Venous ulcers Circulatory System Venous ulcers
Conditions
Interventions
1. Control group: compression bandages
2. Treatment group: compression bandages and maggots
Sponsors
Department of Health
Eligibility
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 04/09/2007: Percentage area debridement following maggot treatment, compared to standard treatment. Previous primary outcome measures: Maggot survival and reduction in time to heal venous leg ulcers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures: Time to healing (in weeks) Please note that previous to this addition there were no secondary outcome measures. | — |
Countries
United Kingdom
Outcome results
None listed