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The primary objective of this study is to evaluate the safety and preliminary performance of EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EASH | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EASH dressing | Device | Apply study dressing for 4 weeks changing at least every 7 days followed by Aquacel for four weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Nature and frequency of adverse events. | All 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer Improvement (wound bed) | Baseline, week 4 and week 8 | |
| Ulcer Improvement (peri-ulcer) | Baseline, week 4 and week 8 or final visit | |
| Healing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Harding | Wound Healing Research Unit, Cardiff University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mikomed | Lodz | Poland | ||||
| Cross Medica |
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| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Reduction in ulcer area |
| Weekly for 4 weeks then biweekly for 4 weeks or final visit |
| Healing | Number of subjects healed | 8 weeks or final visit |
| Healing | Time to healing | 8 weeks or final visit |
| Ulcer pain | Weekly for 4 weeks then biweekly for 4 weeks or final visit |
| Comfort | Weekly for 4 weeks then biweekly for 4 weeks |
| Ease of use | Weekly for 4 weeks then biweekly for 4 weeks |
| Warsaw |
| Poland |
| Medservice | Zabrze | Poland |
| Wound Healing Research Unit | Heathpark | Cardiff | CF14 4XN | United Kingdom |
| Axbridge & Wedmore Medical Practice | Axbridge | Somerset | BS26 2BJ | United Kingdom |
| Arrowe Park Hospital | Upton | Wirral | CH49 5PE | United Kingdom |