DermaRep™ Device in the Treatment of Venous Leg Ulcers

NCT03699072 | Completed

• 1 other identifier: BV-CP-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Evaluation of the performance of DermaRep™ in rate of wound healing.

  12 weeks

• Assessment of Wound Pain

  12 weeks

• DermaRep™ Dressing Application

  12 weeks

• Wound coverage

  12 weeks

• Comparison of healing between the run-in period and the treatment period

  12 weeks

Interventions

DermaRep™ Wound Contact Device DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biovotec AS: lead

Study Sites (6)

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Countess of Chester Hospital

Chester, Ch2 1UL, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Imperial College Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kevin G Mercer, MD

  Bradford Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 9, 2018
• Study Start: November 5, 2018
• Primary Completion: April 1, 2020
• Study Completion: September 16, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

GB (6)