Leg Ulcers
Conditions
Brief 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.
Interventions
DEVICECompression Device
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.
DEVICEProfore
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.
Sponsors
ConvaTec Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer) | 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Healing Measured by Number of Subjects Healed During the 12 Week Study Period | 12 weeks |
Countries
France, Germany, Ireland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Compression Device The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.
Compression Device: 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. | 38 |
| Profore, 4-layer Bandage A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.
Profore: 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. | 52 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 3 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 3 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Compression Device | Profore, 4-layer Bandage | Total |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 16.72 | 62.6 years STANDARD_DEVIATION 15.41 | 61.89 years STANDARD_DEVIATION 15.9 |
| Region of Enrollment France | 1 participants | 5 participants | 6 participants |
| Region of Enrollment Germany | 9 participants | 12 participants | 21 participants |
| Region of Enrollment Ireland | 5 participants | 5 participants | 10 participants |
| Region of Enrollment United Kingdom | 23 participants | 30 participants | 53 participants |
| Sex: Female, Male Female | 21 Participants | 23 Participants | 44 Participants |
| Sex: Female, Male Male | 17 Participants | 29 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 38 | 47 / 52 |
| serious Total, serious adverse events | 0 / 38 | 3 / 52 |
Outcome results
Primary
Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)
Time frame: 12 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Compression Device | Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer) | 33 Number of Subjects with Adverse Events |
| Profore, 4-layer Bandage | Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer) | 47 Number of Subjects with Adverse Events |
Secondary
Healing Measured by Number of Subjects Healed During the 12 Week Study Period
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Compression Device | Healing Measured by Number of Subjects Healed During the 12 Week Study Period | 12 Number of subjects healed |
| Profore, 4-layer Bandage | Healing Measured by Number of Subjects Healed During the 12 Week Study Period | 22 Number of subjects healed |