Condition category
Circulatory System
Date applied
20/04/2009
Date assigned
26/06/2009
Last edited
26/07/2016
Prospective/Retrospective
Retrospectively 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

Prof Christine Moffatt

ORCID ID

Contact details

CRICP
174 Huntingfiled Road
London
SW15 5ES
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UK-08-10-3102343

Study information

Scientific title

Evaluation of the efficacy and the safety of the K-Two® versus Actico® compression systems in the management of venous leg ulcers: a randomised parallel group open label pilot study

Acronym

Study hypothesis

To compare the therapeutic efficacy and the safety of two multilayer compression systems, K-Two® versus Actico®, in the treatment of venous leg ulcers through a randomised controlled clinical trial.

Ethics approval

Not provided at time of registration

Study design

Randomised parallel-group open-label pilot trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Venous leg ulceration

Intervention

Patients will be randomised to either an Actico® bandage or K-Two® bandage system. Follow up will be to a maximum of 12 weeks, or until the trial ulcer heals.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Complete ulcer closure (100% re-epithelialisation) at 12 weeks at the latest.

Secondary outcome measures

1. The time to reach complete ulcer closure
2. The percentage of patients with a reduction of 40% of the leg ulcer area at the last available evaluation compared to baseline
3. The time required to reach this percentage reduction of 40%
4. The absolute leg ulcer surface area reduction (area t0 - area tlast) after the 12 weeks of treatment by the studied compression systems
5. The complete ulcer closure of the studied ulcerated limb
6. The complete ulcer closure of all ulcers located both in studied and controlateral limbs, if existing
7. The local safety of the studied compression systems (emergent local adverse events [LAE])
8. The acceptability of the studied compression systems, by the investigator (characteristics of care dispensed) and by the patient (assessment of pain during dressing changes and between dressing changes)
9. The change frequency of the studied compression systems during the study
10. The slippage of the compression systems at each bandage change
11. The ankle circumference measurements at the following visits: D0, W1, W4 and W12 or at the trial withdrawal in order to follow the evolution of an oedema of the lower limb, if existing
12. The patient's quality of life at baseline and at the end of the treatment period (week 12 or at the end of the treatment whatever reason), using a generic toll, the Venous Leg Ulcer Quality of Life Questionnaire (VLU QoL) in accordance with a standard protocol

Overall trial start date

18/05/2009

Overall trial end date

18/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients over 18 years old, either sex, who have provided his written informed consent
2. Patient who can be followed by the same investigating team for the 12 weeks treatment period
3. Patient who agrees to concord to the study/wear this type of multilayer compression system for at most one week
4. Patient presenting an ankle circumference included between 18 to 32 cm
5. Ulcer between 2 and 50 cm^2 in surface
6. Ulcer duration between 1 and 24 months, for a new leg ulcer (not recurrent)
7. Ulcer duration under 24 months, for a recurrent leg ulcer
8. Venous or mixed leg ulcer (Ankle Brachial Pressure Index greater than 0.8 and less than 1.3 in both legs at inclusion)
9. Ulcer at least 3 cm, from any other wound located on the same limb
10. Leg ulcer treated by a contact layer as a primary dressing (Urgotul®)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

232 (116 in each arm)

Participant exclusion criteria

1. Patient participating in another clinical trial
2. Female patient of childbearing age who does not have any mode of contraception and is able to become pregnant during the study period
3. Patient with known hypersensitivity to one of the components of the tested compression systems
4. Patient with known hypersensitivity to the interface primary dressing (Urgotul®)
5. Patient presenting a neoplasic lesion treated by radiotherapy or chemotherapy or patients treated with immunosuppressive drugs or high-dose corticosteroids
6. Patient who has undergone surgery directly related to his/her venous insufficiency in the 2 months prior to inclusion
7. Patient with a history of deep or superficial vein thrombosis in the 3 months prior to inclusion
8. Patient confined to bed
9. Ulcer for which surgery is scheduled in the 12 weeks after inclusion
10. Ulcer which is clinically infected
11. Ulcer surface area totally (100% of surface) covered with dry fibrinous tissue (sloughy tissue) at inclusion or black necrotic plaque covering more than 10% of ulcer area
12. Cancerous ulcer

Recruitment start date

18/05/2009

Recruitment end date

18/11/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

CRICP
London
SW15 5ES
United Kingdom

Sponsor information

Organisation

Laboratoires Urgo (France)

Sponsor details

42
Rue de Longvic
Chenove
F-21300
France

Sponsor type

Industry

Website

http://www.urgo.com/

Funders

Funder type

Industry

Funder name

Laboratoires Urgo (France)

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

Publication citations

Additional files

Editorial Notes

19/04/2010: the target number of participants was changed from 100 to 232.