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| [ Print-friendly version ] |
| A study to assess the efficacy of maggots as a wound debridement agent for venous leg ulcers under graduated compression bandages |
| ISRCTN | ISRCTN46226449 |
| ClinicalTrials.gov identifier | |
| Public title | A study to assess the efficacy of maggots as a wound debridement agent for venous leg ulcers under graduated compression bandages |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N0106142799; MT4VLU07/A-V5 |
| Study hypothesis |
Current hypothesis as of 04/09/2007:
To determine whether or not maggots are able to survive under layers of compression bandages and whether they provide a clinically beneficial debridement therapy for sloughy venous leg ulcers. Please note that as of 04/09/2007 this trial record was amended. The main reason for these changes are due to the change in the classification of maggots (now classified as an investigational medicinal product), and therefore MHRA approval was to be sought. Before this could be performed, however, a licence number for the investigational medicinal product was to be provided and this, at the time, did not exist. However, the maggots used in this trial do now have a licence number and therefore ethics re-approval and MHRA approval are being sought, and this trial will go ahead as planned. Previous hypothesis: To determine whether or not maggots are able to survive under layers of compression bandages and whether they provide a clinically beneficial and cost effectiveness therapy for sloughy venous leg ulcers. |
| Lay summary | |
| Ethics approval | Ethics approval pending from Southmead Research Ethics Committee as of 04/09/2007. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cardiovascular: Venous ulcers |
| Participants - 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 |
| Participants - 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. |
| Anticipated start date | 03/12/2007 |
| Anticipated end date | 02/06/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 40 (20 in control group + 20 in treatment group) |
| Interventions |
1. Control group: compression bandages
2. Treatment group: compression bandages and maggots This trial was originally stopped in November 2006 due to the reasons stated in the hypothesis. The original anticipated start and end dates of this trial were as follows: Anticipated start date: 05/04/2004 Anticipated end date: 06/04/2004 These have now been updated to the dates found above. |
| Primary outcome measure(s) |
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 outcome measure(s) |
Current secondary outcome measures:
Time to healing (in weeks) Please note that previous to this addition there were no secondary outcome measures. |
| Sources of funding |
1. Gloucestershire R&D Consortium (UK)
2. Vascular Department, Cheltenham General Hospital (UK) 3. NHS R&D Support Funding (UK) |
| Trial website | |
| Publications | |
| Contact name | Mr Colin Davies |
| Address |
Senior Clinical Nurse Specialist Manager
Gloucestershire Leg Ulcer Service Cheltenham General Hospital Sandford Road |
| City/town | Cheltenham |
| Zip/Postcode | GL53 7AN |
| Country | United Kingdom |
| Sponsor | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Address |
The Department of Health
Richmond House 79 Whitehall |
| City/town | London |
| Zip/Postcode | SW1A 2NL |
| Country | United Kingdom |
| Tel | +44 (0)20 7307 2622 |
| Fax | +44 (0)20 7307 2623 |
| dhmail@doh.gsi.org.uk | |
| Sponsor website: | http://www.dh.gov.uk/Home/fs/en |
| Date applied | 30/09/2005 |
| Last edited | 01/06/2009 |
| Date ISRCTN assigned | 30/09/2005 |
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