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 @ 7:30 PM
Ignite Modification Date:
2025-12-24 @ 7:30 PM
NCT ID:
NCT03909503
Eligibility Criteria:
Inclusion Criteria:
* Has at least one of the following types of wounds below the knee: diabetic ulcer, pressure ulcer, venous ulcer, ulcer of mixed-vascular origin, traumatic wound, post-surgical wound
* Wound has been present for at least four weeks
* Wound is free of necrotic tissue or it is possible for necrotic tissue to be removed by typical debridement practices prior to or during treatment phase
* Wound has not healed after using at least one other type of advanced wound care treatment
* Wound size is between 1 and 100 cm2
* 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 free of infection and absence of osteomyelitis.
Exclusion Criteria:
* Pregnant, planning to become pregnant during the study timeframe, or breast feeding
* Has a known allergy to porcine products
* Has an allergy or sensitivity to any type of collagen
* Unable or unwilling to receive porcine collagen
* Wound is infected or there is presence of osteomyelitis
* 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:
NCT03909503
Study Brief:
Protocol Section:
NCT03909503