DermaRep™ Device in the Treatment of Venous Leg Ulcers

Not Applicable

Completed

• Conditions: Venous Leg Ulcer

• Registration Number: NCT03699072
• Lead Sponsor: Biovotec AS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Study Start: 2018-11-05
• Primary Completion: 2020-04-01
• Study Completion: 2020-09-16
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Condition of the surrounding skin	12 weeks	The condition of the surrounding skin will be described qualitatively by the treating clinician
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
Exudate levels	12 weeks	Exudate levels will be assessed qualitatively (low, medium, high) 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
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.
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
Wounds healed at 12 weeks	12 weeks	The number of wounds healed at the final assessment will be assessed.
Time to healing	12 weeks	Time to healing for healed wounds will be assessed in weeks.
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.

Trial Locations

Locations (6)

Countess of Chester Hospital; 🇬🇧 Chester, United Kingdom

Bradford Royal Infirmary; 🇬🇧 Bradford, United Kingdom

Royal Free Hospital; 🇬🇧 London, United Kingdom

Imperial College Charing Cross Hospital; 🇬🇧 London, United Kingdom

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom

Northern General Hospital; 🇬🇧 Sheffield, United Kingdom