Randomized controlled clinical study to assess the clinical efficacy of the 3M* Coban* 2 Layer Compression System compared to a short-stretch compression bandage in the treatment fo venous leg ulcers

Venous leg ulcers are a common clinical problem that increases in prevalence as
thepopulation ages. They are typically a recurring condition and compression
therapy is considered the most effective treatment for such ulcers; in
addition, it is generally believed that compression is also beneficial to
reduce the recurrence of this condition. The cost of chronic venous leg ulcers
is high because of the ongoing care that they require, and the quality of life
of the subjects is jeopardized by this condition. Adequate treatment is
effective at improving the quality of life in these subjects. A new quality of
life tool (the Cardiff Wound Impact Schedule) has been developed specifically
for leg ulcers and diabetic foot ulcers.

The efficacy of a compression bandage is related to how well it holds in place
to provide continued adequate compression and to subject acceptance. The more
comfortable the bandage is, the more likely the subjects are to wear it as
prescribed and to obtain the expected benefit in terms of wound healing. This
protocol compares a new compression bandage with an established short-stretch
compression bandage to evaluate the efficacy with respect to healing rate
(primary endpoint) during a 12-week treatment period.

The objective of the study is to evaluate the clinical efficacy of 3M* Coban* 2
Layer Compression System in the treatment of venous leg ulcers compared to
Rosidal® K shortstretch compression bandage (Lohmann & Rauscher, Rengsdorf,
Germany).

This study will be a prospective, randomized controlled study with blinded
assessment of the primary endpoint. Suitable patients will be randomly
allocated to one compression therapy system based on the size of the ulcer: 3M*
Coban* 2 Layer Compression System or Rosidal® K short-stretch compression
bandage. Subjects will be given a randomization number which serves as a unique
identifier of the subject. When both legs require compression therapy, both
legs receive the same compression therapy. An indendent reviewer, who is
blinded to the subjects treatment, will reassess the healing endpoint.

Study duration:
Each subject will be followed for a treatment period of up to 12 weeks
including a minimum of 13 visits required if treated is performed for a period
of 12 weeks. Due to early healing of the study ulcer the participation of a
subject could be shorter.

Not applicable

The patient needs to attend to study site every 7 days to get the bandages
changed. If necessary the bandages can be changed more often. The patient will
then have to fill in a memory card in order to keep track of the intermittend
bandage changes. He will have to fill in a Quality of life qestionnaire at the
beginning and at the end of the study.

The risks include the possibility of experiencing following side effects: pain,
inflammation, irritation, skin damage, allergic reactions. Moreover the wound
condition may not heal while taking part in the study.

The potential benefit is that the product may prove to be more effective than
the other products. The bandage may require changing less often, which mean
less discomfort for the patient and less disruption to the natural healing
process. The treatment costs can be optimized.