DermaRep™ Device in the Treatment of Venous Leg Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-centre, Pilot, Prospective Trial of DermaRep™ Device in the Treatment of Venous Leg Ulcers

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Device: DermaRep™ Wound Contact Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: DermaRep™ Wound Contact Device|Treatment of venous leg ulcers once weekly for 8 weeks along with standard of care dressings|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |