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This is a First in Human clinical study on the safety and effectiveness of DermaRep™ wound contact dressing. Patients with venous leg ulcers will be treated with standard of care dressings and compression for 4 weeks to establish a baseline wound healing response. All patients will then be treated with DermaRep™ wound contact dressing in addition to standard of care for a further 8 weeks. If the wound has not healed, patients will continue treatment with standard of care only for a further 4 weeks. All patients will be assessed at the 16 week timepoint, the primary endpoint.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DermaRep™ Wound Contact Device | Device | Treatment of venous leg ulcers once weekly for 8 weeks along with standard of care dressings |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of adverse events following DermaRep™ treatment | Potential adverse events following DermaRep™ treatment will be compared to the pre-treatment phase, the 4 week run-in period. Adverse events will include active bleeding, clinical infection and device deficiencies. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the performance of DermaRep™ in rate of wound healing. | Qualitative evaluation of wound healing progression will be assessed visually by the treating clinician | 12 weeks |
| Assessment of Wound Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin G Mercer, MD | Bradford Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bradford Royal Infirmary | Bradford | BD9 6RJ | United Kingdom | |||
| Countess of Chester Hospital |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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Wound pain will be assessed using a VAS score.
| 12 weeks |
| DermaRep™ Dressing Application | Pain on dressing changes will be assessed using a VAS score | 12 weeks |
| Wound coverage | Wound coverage will be calculated as a percentage from baseline to the end of the study using wound grids for area measurement | 12 weeks |
| Comparison of healing between the run-in period and the treatment period | The rate of progression in wound healing during the treatment phase relative to the pre-treatment run-in phase will be assessed by surface area measurement using wound grids. | 12 weeks |
| Wounds healed at 12 weeks | The number of wounds healed at the final assessment will be assessed. | 12 weeks |
| Reduction in wound area/volume | The % reduction in area and volume of the wound will be assessed by measurement with wound grids and a ruler. | 12 weeks |
| Time to healing | Time to healing for healed wounds will be assessed in weeks. | 12 weeks |
| Exudate levels | Exudate levels will be assessed qualitatively (low, medium, high) by the treating clinician. | 12 weeks |
| Condition of the surrounding skin | The condition of the surrounding skin will be described qualitatively by the treating clinician | 12 weeks |
| Chester |
| Ch2 1UL |
| United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Imperial College Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| Northern General Hospital | Sheffield | S5 7AU | United Kingdom |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |