Back to resultsDermaRep™ Device in the Treatment of Venous Leg Ulcers (DermaRep™)
Primary Purpose
Venous Leg Ulcer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
DermaRep™ Wound Contact Device
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer
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
Sites / Locations
- Bradford Royal Infirmary
- Countess of Chester Hospital
- Royal Free Hospital
- Imperial College Charing Cross Hospital
- Manchester Royal Infirmary
- Northern General Hospital
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Assessment of Wound Pain
Wound pain will be assessed using a VAS score.
DermaRep™ Dressing Application
Pain on dressing changes will be assessed using a VAS score
Wound coverage
Wound coverage will be calculated as a percentage from baseline to the end of the study using wound grids for area measurement
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.
Wounds healed at 12 weeks
The number of wounds healed at the final assessment will be assessed.
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.
Time to healing
Time to healing for healed wounds will be assessed in weeks.
Exudate levels
Exudate levels will be assessed qualitatively (low, medium, high) by the treating clinician.
Condition of the surrounding skin
The condition of the surrounding skin will be described qualitatively by the treating clinician
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03699072
Brief Title
DermaRep™ Device in the Treatment of Venous Leg Ulcers
Acronym
DermaRep™
Official Title
A Multi-centre, Pilot, Prospective Trial of DermaRep™ Device in the Treatment of Venous Leg Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
September 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biovotec AS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
DermaRep™ Wound Contact Device
Intervention Description
Treatment of venous leg ulcers once weekly for 8 weeks along with standard of care dressings
Primary Outcome Measure Information:
Title
Assessment of adverse events following DermaRep™ treatment
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Evaluation of the performance of DermaRep™ in rate of wound healing.
Description
Qualitative evaluation of wound healing progression will be assessed visually by the treating clinician
Time Frame
12 weeks
Title
Assessment of Wound Pain
Description
Wound pain will be assessed using a VAS score.
Time Frame
12 weeks
Title
DermaRep™ Dressing Application
Description
Pain on dressing changes will be assessed using a VAS score
Time Frame
12 weeks
Title
Wound coverage
Description
Wound coverage will be calculated as a percentage from baseline to the end of the study using wound grids for area measurement
Time Frame
12 weeks
Title
Comparison of healing between the run-in period and the treatment period
Description
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.
Time Frame
12 weeks
Title
Wounds healed at 12 weeks
Description
The number of wounds healed at the final assessment will be assessed.
Time Frame
12 weeks
Title
Reduction in wound area/volume
Description
The % reduction in area and volume of the wound will be assessed by measurement with wound grids and a ruler.
Time Frame
12 weeks
Title
Time to healing
Description
Time to healing for healed wounds will be assessed in weeks.
Time Frame
12 weeks
Title
Exudate levels
Description
Exudate levels will be assessed qualitatively (low, medium, high) by the treating clinician.
Time Frame
12 weeks
Title
Condition of the surrounding skin
Description
The condition of the surrounding skin will be described qualitatively by the treating clinician
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin G Mercer, MD
Organizational Affiliation
Bradford Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Countess of Chester Hospital
City
Chester
ZIP/Postal Code
Ch2 1UL
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Imperial College Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
DermaRep™ Device in the Treatment of Venous Leg Ulcers
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