DermaRep™ Device in the Treatment of Venous Leg Ulcers

NCT ID: NCT03699072

Last Updated: 2020-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2020-09-16

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.

Conditions

Venous Leg Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

DermaRep™ Wound Contact Device

Treatment of venous leg ulcers once weekly for 8 weeks along with standard of care dressings

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biovotec AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin G Mercer, MD

Role: PRINCIPAL_INVESTIGATOR

Bradford Teaching Hospitals NHS Foundation Trust

Locations

Bradford Royal Infirmary

Bradford, , United Kingdom

Countess of Chester Hospital

Chester, , 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

Countries

United Kingdom

Other Identifiers

BV-CP-01

Identifier Type: -

Identifier Source: org_study_id