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
Protocol serial number	N0106142799; MT4VLU07/A-V5
Sponsor	Department of Health
Funders	Gloucestershire R&D Consortium (UK), Vascular Department, Cheltenham General Hospital (UK), NHS R&D Support Funding (UK)

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

Senior Clinical Nurse Specialist Manager
Gloucestershire Leg Ulcer Service
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(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.
Key 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.
Completion date	02/06/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	40
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

United Kingdom
England

Study participating centre

Cheltenham General Hospital

Cheltenham
GL53 7AN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes