Clinical trial NCT03699072: DermaRep™ Device in the Treatment of Venous Leg Ulcers
Official title: A Multi-centre, Pilot, Prospective Trial of DermaRep™ Device in the Treatment of Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: Biovotec AS
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Assessment of adverse events following DermaRep™ treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Evaluation of the performance of DermaRep™ in rate of wound healing.
timeFrame: 12 weeks
measure: Assessment of Wound Pain
timeFrame: 12 weeks
measure: DermaRep™ Dressing Application
timeFrame: 12 weeks
measure: Wound coverage
timeFrame: 12 weeks
measure: Comparison of healing between the run-in period and the treatment period
timeFrame: 12 weeks
measure: Wounds healed at 12 weeks
timeFrame: 12 weeks
measure: Reduction in wound area/volume
timeFrame: 12 weeks
measure: Time to healing
timeFrame: 12 weeks
measure: Exudate levels
timeFrame: 12 weeks
measure: Condition of the surrounding skin
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Imperial College Charing Cross Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
affiliation: Bradford Teaching Hospitals NHS Foundation Trust
name: Kevin G Mercer, MD
role: PRINCIPAL_INVESTIGATOR
References: