An interventional study of DermaRep™ Wound Contact Device in Venous Leg Ulcer, sponsored by Biovotec AS. Completed at 6 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-16.
Sponsored by Biovotec AS · Not applicable, Interventional, and Treatment
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.
378 studies on the registry are indexed under Varicose Ulcer; 79 are open to participants now.
This study's enrollment of 39 is below the median of 65 across 324 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →This is the only study on the registry with Biovotec AS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment of venous leg ulcers once weekly for 8 weeks along with standard of care dressings
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
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
Plan to share: Undecided
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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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