Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
19/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Colin Davies

ORCID ID

Contact details

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25300315

Publication citations

Additional files

Editorial Notes