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DermaRep™ Device in the Treatment of Venous Leg Ulcers

NCT03699072 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-12-16

No results posted yet for this study

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

Interventions

DEVICE

DermaRep™ Wound Contact Device

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

Sponsors & Collaborators

  • Biovotec AS

    lead INDUSTRY

Principal Investigators

  • Kevin G Mercer, MD · Bradford Teaching Hospitals NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2020-04-01
Completion
2020-09-16

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03699072 on ClinicalTrials.gov