DermaRep™ Device in the Treatment of Venous Leg Ulcers

Biovotec

Status: Completed

Conditions: Venous Leg Ulcer

Treatments: Device: DermaRep™ Wound Contact Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03699072

BV-CP-01

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)