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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compression device | Experimental | 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. |
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| Profore, 4-layer bandage | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer) | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Healing Measured by Number of Subjects Healed During the 12 Week Study Period | 12 weeks |
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Inclusion Criteria:
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathon Hopper, MD | ConvaTec Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Practice | Neuilly-sur-Seine | France | ||||
| Groupe Hospitalier Saint-Joseph |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Profore | Device | 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. |
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| Paris |
| France |
| Hautarzt Phlebologe Allergologe | Freiburg im Breisgau | Germany |
| Private Practice | Gilching | Germany |
| Private Practice | Hamburg | Germany |
| The Adelaide & Meath Hospital | Dublin | Ireland |
| Mid-Western Regional Hospital | Limerick | Ireland |
| Cork University Hospital | Wilton | Ireland |
| Dermatology Day Unit; Monklands Hospital | Airdrie | United Kingdom |
| The Wilson Practice, Alton Health Centre | Alton | United Kingdom |
| Wound Healing Research Unit; Cardiff University | Cardiff | United Kingdom |
| Tissue Viability Consultancy | Eastbourne | United Kingdom |
| Institute of Wound Care, The University of Hull | Hull | United Kingdom |
| Diving Diseases Research Centre, Hyperbaric Medical Centre | Plymouth | United Kingdom |
| University Dept of Vascular | Solihull | United Kingdom |
| Medical Physics & Bioengineering, Southampton University Hospital | Southampton | United Kingdom |
| Department of Vascular Surgery, Good Hope Hospital | Sutton Coldfield | United Kingdom |
| Trowbridge Community Hospital | Trowbridge | United Kingdom |
| Arrowe Park Hospital | Upton | United Kingdom |
| Short Health Clinic | Willenhall | United Kingdom |
| FG001 | 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer) | Posted | Number | Number of Subjects with Adverse Events | 12 Weeks |
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| Secondary | Healing Measured by Number of Subjects Healed During the 12 Week Study Period | Posted | Number | Number of subjects healed | 12 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 38 | 33 | 38 | ||
| EG001 | 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. | 3 | 52 | 47 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blisters/ulcer/skin breakdown/weepy under wfr/dsg | Skin and subcutaneous tissue disorders |
| |||
| Deep vein thrombosis | Blood and lymphatic system disorders |
| |||
| Prostatic Procedures | Surgical and medical procedures |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maceration | Skin and subcutaneous tissue disorders |
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| Pain attributed to wound | Skin and subcutaneous tissue disorders |
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| Erythema | Skin and subcutaneous tissue disorders |
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| Eczema/worsening | Skin and subcutaneous tissue disorders |
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| Blisters/ulcer/skin breakdown/weepy under wfr/dsg | Skin and subcutaneous tissue disorders |
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| Oedema | Blood and lymphatic system disorders |
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| Dry/Flaky skin under device | Skin and subcutaneous tissue disorders |
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| Infection, Non-Study Location | Infections and infestations |
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| Infection, Study Location | Infections and infestations |
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| Increase in drainage/exudate | Blood and lymphatic system disorders |
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| Pain lower leg | Vascular disorders |
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| Wound enlarged/deteriorated | Skin and subcutaneous tissue disorders |
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| Necrotic or sloughy wound | Skin and subcutaneous tissue disorders |
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| Hypergranulation | Skin and subcutaneous tissue disorders |
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| Chafing under device | Skin and subcutaneous tissue disorders |
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| Blstrs/ulcr/skin brkdwn/weepy-diff.location | Skin and subcutaneous tissue disorders |
| |||
| Pain/discomf at ankle, study leg | Skin and subcutaneous tissue disorders |
| |||
| Pain/discomf at shin, study leg | Skin and subcutaneous tissue disorders |
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| Pain/discomf at ankle w/irrit, study leg | Skin and subcutaneous tissue disorders |
| |||
| Headache | General disorders |
| |||
| Cellulitis | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Peters, Director of Clinical Affairs | ConvaTec | 07889841338 | kim.peters@convatec.com |
| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D048228 | Intermittent Pneumatic Compression Devices |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Male |
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| Ireland |
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| Germany |
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| United Kingdom |
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