Treatment of Wounds Using Oasis® ECM

C

Cook Group

Status

Completed

Conditions

Non-healing Wound

Treatments

Device: Oasis Extracellular Matrix

Study type

Observational

Funder types

Industry

Identifiers

NCT03632031
17-001

Details and patient eligibility

About

The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for different types of chronic wounds in the community setting in the United Kingdom.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting

Exclusion criteria

  • Age < 18 years
  • Unable or unwilling to provide informed consent
  • Unable or unwilling to comply with the study follow-up schedule, and procedures
  • Simultaneously participating in another investigational drug or device study
  • Target wound area is < 2 cm2 or > 140 cm2 after baseline debridement
  • Target wound has reduced in area by > 40% with 4 weeks of documented standard of care therapy
  • Known allergy to pig or porcine products
  • Systemic infection
  • Infection of the target wound as determined by the collection of pus
  • Osteomyelitis
  • ABI/TBI < 0.6 obtained within 3 months prior to the screening visit
  • Other exclusions may apply

Trial design

40 participants in 1 patient group

Patients with chronic non-healing wounds
Description:
Patients with chronic non-healing wounds with planned use of OASIS Extracellular Wound Matrix
Treatment:
Device: Oasis Extracellular Matrix

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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