Venous Leg Ulcer
Conditions
Brief summary
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.
Interventions
DEVICEDermaRep™ Wound Contact Device
Treatment of venous leg ulcers once weekly for 8 weeks along with standard of care dressings
Sponsors
Biovotec AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient is at least 18 years of age * The patient is male and female not pregnant or lactating and using contraception * The patient has a confirmed venous leg ulcer with:Confirmed actively managed reflux; No exposed tendon or bone; Ulcer surface area between 2cm2 and 80cm; ABPI\>0.8 * The patient agrees to abstain from enrolment in any other clinical trial for the duration of the study * The patient is able to understand the aims and objectives of the trial and is willing to consent
Exclusion criteria
* Study treatment area has exposed bone or tendon * Poorly controlled diabetes * Arterial insufficiency (ABPI\<0.8) * Pregnant/lactating females (tested as per institutional requirements) * The patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma granulosum) * The patient is unable to follow the procedures set by the protocol * The patient has a history of any significant cardiac, pulmonary, renal. hepatic, neurological and/or immune dysfunction that in the opinion of the investigator may compromise patient safety or study objectives * The patient is taking any known medications that in the opinion of the investigator may compromise patient safety or the study objectives * The patient has any known allergies to any of the device materials to be used in the trial (egg allergy) * The patient is a vulnerable or protected adult * The patient is unable to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of adverse events following DermaRep™ treatment | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the performance of DermaRep™ in rate of wound healing. | 12 weeks | Qualitative evaluation of wound healing progression will be assessed visually by the treating clinician |
| Assessment of Wound Pain | 12 weeks | Wound pain will be assessed using a VAS score. |
| DermaRep™ Dressing Application | 12 weeks | Pain on dressing changes will be assessed using a VAS score |
| Wound coverage | 12 weeks | Wound coverage will be calculated as a percentage from baseline to the end of the study using wound grids for area measurement |
| Comparison of healing between the run-in period and the treatment period | 12 weeks | 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. |
| Wounds healed at 12 weeks | 12 weeks | The number of wounds healed at the final assessment will be assessed. |
| Reduction in wound area/volume | 12 weeks | The % reduction in area and volume of the wound will be assessed by measurement with wound grids and a ruler. |
| Time to healing | 12 weeks | Time to healing for healed wounds will be assessed in weeks. |
| Exudate levels | 12 weeks | Exudate levels will be assessed qualitatively (low, medium, high) by the treating clinician. |
| Condition of the surrounding skin | 12 weeks | The condition of the surrounding skin will be described qualitatively by the treating clinician |
Countries
United Kingdom
Outcome results
None listed