DermaRep™ Device in the Treatment of Venous Leg Ulcers (DermaRep™)

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

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.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: DermaRep™ Wound Contact Device

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Bradford Royal Infirmary
  • Chester, United Kingdom, CH2 1UL
    • Countess of Chester Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • London, United Kingdom, W6 8RF
    • Imperial College Charing Cross Hospital
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Infirmary
  • Sheffield, United Kingdom, S5 7AU
    • Northern General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biovotec AS
• Investigators: Principal Investigator: Kevin G Mercer, MD, Bradford Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2018
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): September 16, 2020

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (ACTUAL): October 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: BV-CP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No