DermaRep™ Device in the Treatment of Venous Leg Ulcers

Venous Leg Ulcer Clinical Trial

— DermaRep™  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699072
• Other study ID #: BV-CP-01
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: September 16, 2020

Study information

• Verified date: December 2020
• Source: Biovotec AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 16, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Countess of Chester Hospital	Chester
United Kingdom	Imperial College Charing Cross Hospital	London
United Kingdom	Royal Free Hospital	London
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	Northern General Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Biovotec AS

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Assessment of Wound Pain	Wound pain will be assessed using a VAS score.	12 weeks
Secondary	DermaRep™ Dressing Application	Pain on dressing changes will be assessed using a VAS score	12 weeks
Secondary	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
Secondary	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
Secondary	Wounds healed at 12 weeks	The number of wounds healed at the final assessment will be assessed.	12 weeks
Secondary	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
Secondary	Time to healing	Time to healing for healed wounds will be assessed in weeks.	12 weeks
Secondary	Exudate levels	Exudate levels will be assessed qualitatively (low, medium, high) by the treating clinician.	12 weeks
Secondary	Condition of the surrounding skin	The condition of the surrounding skin will be described qualitatively by the treating clinician	12 weeks