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Completed

NCT Number: NCT03632031

Treatment of Wounds Using Oasis® ECM

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

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Key information

Conditions

Non-healing Wound Cardiovascular Diseases Leg Ulcer Pressure 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

Nursery Park Health Centre, Ashington, United Kingdom

Loading trial locations.

About this study

This prospective randomized controlled clinical study is being performed to evaluate the safety and performance of OASIS Extracellular Matrix when used as a treatment for donor site wounds as compared to standard wound care. This study will consent and treat up to 40 patients with 20 patients assigned to the OASIS treatment group and 20 patients assigned to the standard wound care treatment group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Treatment and study plan

Oasis Extracellular Matrix

Device

Patients will receive OASIS Extracellular Matrix according to the Instruction for Use

Standard Care (in control arm)

Other

Donor site will be treated with standard care.

Primary outcomes

  1. Wound healing

    Time frame: 12 weeks

    To demonstrate the percentage of patients with wounds progressing to at least 50% healing

Secondary outcomes

  1. Wound closure- Percentage

    Time frame: up to 12 weeks

    Percentage of patients with complete wound closure

  2. Wound closure- Mean number of weeks

    Time frame: up to 12 weeks

    mean number of weeks to complete wound closure

  3. Wound closure- Mean Percentage

    Time frame: up to 12 weeks

    Mean percent wound closure

  4. Patient reported Quality of Life measurement

    Time frame: up to 12 weeks

    The Wound Quality of Life (QoL) questionnaire is used for measurement of Health-Related Quality of Life in patients with chronic wounds. The total value of this measurement is derived from an average of 17 questions; each question has a value of a minimum of 1 and a maximum of 5. The lower the score, the better the outcome. Subscales are not combined to compute a total score.

  5. Adverse Events

    Time frame: up to 12 weeks

    Summary of adverse events reported

Sponsors and collaborators

Lead sponsor

Cook Biotech Incorporated

Industry

Registry information

Official study title

Treatment of Wounds Using Oasis® Extracellular Matrix in the Community Setting

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2018
Registry last updated
Feb 18, 2026

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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