Compression Device Versus 4-layer Compression System

A Phase II Study to Compare the Effect of a Compression Device to That of a 4-layer Compression System on Subjects With Venous Leg Ulcers.

A prospective, Phase II, stratified, randomized study to compare the safety, ulcer healing, patient compliance (concordance) and resource utilisation of a compression device with IPC mode to a Class 3(c) UK standard graduated compression regime (4- layer system) on subjects with venous leg ulcers.

Inclusion Criteria:

• Subjects over 18 years, willing and able to provide written informed consent
• Subjects able to wear the compression device and the comparative regime and follow the requirements of the clinical investigation plan
• Subjects who had an ankle to brachial pressure index (ABPI) of 0.8 or greater
• Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) 2 cm2 in size or greater, who required graduated compression
• Subjects who were outpatients

Exclusion Criteria:

• Subjects with a history of skin sensitivity to any of the components of the study product, comparator product or standard dressings

• *Subjects with more than one ulcer on the test leg

• Subjects who had previously been entered into the study or a previous Amadeus study (U327, U332 or U337) or had participated in a previous clinical study within the past 3 months

• Subjects with any condition that prevented application and removal of the device without external assistance

• Subjects who had an active Deep Vein Thrombosis (DVT) or a recent DVT within the last 3 months

• Subjects who exhibited any other medical condition which, according to the Investigator, justified the subject's exclusion from the study

• Subjects who had leg sizes outside the following range:

  • Ankle - 12cm to 44cm
  • Calf - 22cm to 60cm
  • Below knee - 22cm to 68cm

• Subjects who had an index venous leg ulcer greater in size than 10cm in any one dimension

• Diabetic subjects with advanced small vessel disease

• Denotes the exclusion criterion was amended and approved by the Ethics Committees as follows:

• Amendment #1 dated 27th March 2007:

  *Diabetic subjects who, in the opinion of the investigator, were not in reasonable metabolic control or had a history of hospitalisation within the last six months for the management of blood sugar and/or diabetic subjects with advanced small vessel disease

• Amendment #2 dated 2nd August 2007:

  *Subjects who had an index venous leg ulcer greater in size than 15cm in any one dimension

• Amendment #3 dated 5th October 2007:

  • Deletion of exclusion criterion 'Subjects with more than one ulcer on the test leg' to permit inclusion of subjects with multiple ulcers on the test leg