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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA study to assess the efficacy of maggots as a wound debridement agent for venous leg ulcers under graduated compression bandages
Study objectivesCurrent 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) studiedCardiovascular: Venous ulcers
Intervention1. Control group: compression bandages
2. Treatment group: compression bandages and maggots
Intervention typeOther
Primary outcome measureCurrent 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 measuresCurrent secondary outcome measures:
Time to healing (in weeks)

Please note that previous to this addition there were no secondary outcome measures.
Overall study start date03/12/2007
Completion date02/06/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
Lower age limit18 Years
SexNot Specified
Target number of participants40 (20 in control group + 20 in treatment group)
Key inclusion criteriaInclusion 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 criteriaExclusion 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 enrolment03/12/2007
Date of final enrolment02/06/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Cheltenham General Hospital
Cheltenham
GL53 7AN
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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