Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT03723603
Eligibility Criteria:
Inclusion Criteria:
* Has one of the following types of wounds below the knee: diabetic ulcers, pressure ulcers, venous ulcers, ulcers of mixed-vascular origin, traumatic wounds, or post-surgical wounds
* Wound has been present for at least four weeks
* Wound is free of necrotic tissue or debridement practices will take place prior to initial visit in order to remove necrotic tissue
* Wound has failed at least one wound care treatment
* Wound size is between 1 and 100 square centimeters
* Patient has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, measured within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index greater than 0.8 and no worse than mild disease on segmental pressures.
* Wound is confirmed as being free of infection and absence of osteomyelitis
Exclusion Criteria:
* Pregnant, planning to become pregnant during the study timeframe, or breast feeding
* Unable or unwilling to receive porcine collagen
* Wound is infected or presence of osteomyelitis
* Allergy or sensitivity to collagen
* Inability, in the opinion of the Investigator to follow protocol requirements, attend follow up visits in a timely manner, or otherwise comply with the requirements of the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03723603
Study Brief:
Protocol Section:
NCT03723603