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 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT03312595
Eligibility Criteria:
Inclusion Criteria:
* Male or female age 18 or older
* Patient's ulcer must be diabetic in origin, located at least in part on the plantar surface and larger than 1cm2 after the run-in period. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement
* Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
* Ulcer must be present for a minimum of four weeks before enrollment/randomization, with documented failure of prior treatment to heal the wound. A two-week run in period will precede enrollment/randomization in the trial to document the indolent nature of the patients selected
* Patient does not exhibit clinical signs / symptoms of infection upon gross observation (at least 3 of the following: pain, redness, purulence, exudate, temperature) or have been diagnosed with an active infection at time of screening
* Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study
* Patient has adequate control of diabetes, as demonstrated by one of the following within 30 days of screening:
* HbA1c \< 12%
* Serum Creatinine \< 3.0mg/dl
* Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days of the first screening visit:
* Dorsum transcutaneous oxygen test (TcPO2) with results
≥30mmHg, OR
* ABIs with results of ≥0.7 and ≤1.5, OR
* Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg
Exclusion Criteria:
* Patients presenting with an ulcer probing to bone (UT Grade IIIA-D)
* Patients whose index diabetic foot ulcers are greater than 25cm2
* Patient has an additional wound within 3cm of the study wound
* Patients not in reasonable metabolic control
* Patients with a known history of poor compliance with medical treatments
* Patients who have been previously enrolled into this study, or are presently participating in a clinical trial with DFU indications
* Patients with known or suspected local skin malignancy to the index diabetic ulcer
* Patients diagnosed with autoimmune connective tissues diseases
* Patients that have received a graft material on the study ulcer within the previous 30 days
* Patients who are pregnant or breast feeding
* Patients who are taking medications that are considered immune system modulator
* Study wound has closed \> 30% over the two-week run-in period
* Patients with a known allergy to resorbable suture materials
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03312595
Study Brief:
Protocol Section:
NCT03312595