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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Treatment of venous leg ulcers once weekly for 8 weeks along with standard of care dressings
Bradford Royal Infirmary
Bradford, United Kingdom
Countess of Chester Hospital
Chester, United Kingdom
Royal Free Hospital
London, United Kingdom
Imperial College Charing Cross Hospital
London, United Kingdom
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.
Time frame: 12 weeks
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
Time frame: 12 weeks
Assessment of Wound Pain
Wound pain will be assessed using a VAS score.
Time frame: 12 weeks
DermaRep™ Dressing Application
Pain on dressing changes will be assessed using a VAS score
Time frame: 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
Time frame: 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.
Time frame: 12 weeks
Wounds healed at 12 weeks
The number of wounds healed at the final assessment will be assessed.
Time frame: 12 weeks
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Manchester Royal Infirmary
Manchester, United Kingdom
Northern General Hospital
Sheffield, United Kingdom
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.
Time frame: 12 weeks
Time to healing
Time to healing for healed wounds will be assessed in weeks.
Time frame: 12 weeks
Exudate levels
Exudate levels will be assessed qualitatively (low, medium, high) by the treating clinician.
Time frame: 12 weeks
Condition of the surrounding skin
The condition of the surrounding skin will be described qualitatively by the treating clinician
Time frame: 12 weeks