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Completed

NCT Number: NCT03699072

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bradford Royal Infirmary, Bradford, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DermaRep™ Wound Contact Device

Device

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

Primary outcomes

  1. Assessment of adverse events following DermaRep™ treatment

    Time frame: 12 weeks

    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 outcomes

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

    Time frame: 12 weeks

    Qualitative evaluation of wound healing progression will be assessed visually by the treating clinician

  2. Assessment of Wound Pain

    Time frame: 12 weeks

    Wound pain will be assessed using a VAS score.

  3. DermaRep™ Dressing Application

    Time frame: 12 weeks

    Pain on dressing changes will be assessed using a VAS score

  4. Wound coverage

    Time frame: 12 weeks

    Wound coverage will be calculated as a percentage from baseline to the end of the study using wound grids for area measurement

  5. Comparison of healing between the run-in period and the treatment period

    Time frame: 12 weeks

    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.

  6. Wounds healed at 12 weeks

    Time frame: 12 weeks

    The number of wounds healed at the final assessment will be assessed.

  7. Reduction in wound area/volume

    Time frame: 12 weeks

    The % reduction in area and volume of the wound will be assessed by measurement with wound grids and a ruler.

  8. Time to healing

    Time frame: 12 weeks

    Time to healing for healed wounds will be assessed in weeks.

  9. Exudate levels

    Time frame: 12 weeks

    Exudate levels will be assessed qualitatively (low, medium, high) by the treating clinician.

  10. Condition of the surrounding skin

    Time frame: 12 weeks

    The condition of the surrounding skin will be described qualitatively by the treating clinician

Sponsors and collaborators

Lead sponsor

Biovotec AS

Industry

Registry information

Official study title

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

Acronym: DermaRep™

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2018
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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