A study to assess the efficacy of maggots as a wound debridement agent for venous leg ulcers under graduated compression bandages
| ISRCTN | ISRCTN46226449 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46226449 |
| Secondary identifying numbers | N0106142799; MT4VLU07/A-V5 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 19/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Colin Davies
Scientific
Scientific
Senior Clinical Nurse Specialist Manager
Gloucestershire Leg Ulcer Service
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A study to assess the efficacy of maggots as a wound debridement agent for venous leg ulcers under graduated compression bandages |
| Study objectives | 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. 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. 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. The original overall trial start and end dates were as follows: Overall trial start date: 05/04/2004 Overall trial end date: 06/04/2004 |
| Ethics approval(s) | Ethics approval pending from Southmead Research Ethics Committee as of 04/09/2007 |
| Health condition(s) or problem(s) studied | Cardiovascular: Venous ulcers |
| Intervention | 1. Control group: compression bandages 2. Treatment group: compression bandages and maggots |
| Intervention type | Other |
| Primary outcome measure | 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 measures | Current secondary outcome measures: Time to healing (in weeks) Please note that previous to this addition there were no secondary outcome measures. |
| Overall study start date | 03/12/2007 |
| Completion date | 02/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 40 (20 in control group + 20 in treatment group) |
| Key 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 |
| Key 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. |
| Date of first enrolment | 03/12/2007 |
| Date of final enrolment | 02/06/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cheltenham General Hospital
Cheltenham
GL53 7AN
United Kingdom
GL53 7AN
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Gloucestershire R&D Consortium (UK)
No information available
Vascular Department, Cheltenham General Hospital (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2015 | Yes | No |
