Compression Device Versus 4-layer Compression System
Condition: Leg Ulcers
MeSH terms: Leg Ulcer
Intervention: Compression Device; Profore
Intervention description: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:
Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.
Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day.; Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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