Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0106142799; MT4VLU07/A-V5
Study information
Scientific title
A study to assess the efficacy of maggots as a wound debridement agent for venous leg ulcers under graduated compression bandages
Acronym
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.
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
Ethics approval pending from Southmead Research Ethics Committee as of 04/09/2007
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular: Venous ulcers
Intervention
1. Control group: compression bandages
2. Treatment group: compression bandages and maggots
Intervention type
Other
Phase
Drug names
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 trial start date
03/12/2007
Overall trial end date
02/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
40 (20 in control group + 20 in treatment group)
Participant 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.
Recruitment start date
03/12/2007
Recruitment end date
02/06/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cheltenham General Hospital
Cheltenham
GL53 7AN
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Gloucestershire R&D Consortium (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Vascular Department, Cheltenham General Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25300315