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:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT03232333
Eligibility Criteria:
Inclusion Criteria:
* 18 years old or older at time of initial visit
* Have Type I or Type II diabetes
* Have a neuropathic diabetic foot ulcer with the following characteristics:
* Is greater than 1 cm2 and less than or equal to 12 cm2
* Has failed to close following at least 2 treatments with a biologic
* Has been present for 90 days or longer
* Does not show signs of infection
* Is full thickness (Wagner Grade I or II)
* Located distal to the malleolus
* Depth of less than or equal to 5 mm
* No exposed capsule, tendon or bone
* No tunneling, undermining or sinus tracts
* Not between the toes
* Be willing and able to maintain required off-loading of affected limb
* Be willing and able to perform necessary dressing changes
* Have at least one of the following:
* An Ankle-brachial index (ABI) ≥ 0.8
* TcPO2 of ≥ 30 mmHg
* A toe pressure of ≥ 50 mmHg
Exclusion Criteria:
* Be pregnant or be planning to become pregnant during the study
* Have had a Chopart's Amputation (or higher)
* Have a history of bone cancer of the affected limb
* Be undergoing dialysis
* Have active osteomyelitis or be receiving treatment for osteomyelitis
* Be diagnosed with unstable Charcot Foot on the affected side
* Have an HbA1c level of ≥ 12% within the past 90 days
* Have another ulcer within 2 cm of the study ulcer
* Be immunocompromised or at risk of immunosuppression as determined by the treating investigator
* Have a known collagen vascular disease or connective tissue disease
* Have received treatment of the study ulcer with a skin substitute product or topical growth factor within the past 4 weeks
* Be participating in another medical research study
* Have a sensitivity to porcine material
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03232333
Study Brief:
Protocol Section:
NCT03232333