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 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT01353495
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria and Population:
* Male or female age 18 or older
* Informed consent must be obtained
* Patient's ulcer must be diabetic in origin and larger than 1cm2. 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).
* Patient's ulcer must exhibit no clinical signs of infection.
* Patient is of legal consenting age.
* 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 circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
* Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR
* ABIs with results of ≥0.7 and ≤1.2, OR
* Doppler arterial waveforms,which are triphasicor biphasic at the ankle of affected leg
Exclusion Criteria:
* Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
* Patients whose index diabetic foot ulcers are greater than 25cm2.
* Patients considered not in reasonable metabolic control, confirmed by an HgA1c greater than 12% within previous 90 days,
* Patients whose serum creatinine levels are 3.0mg/dl or greater.
* Patients with a known history of poor compliance with medical treatments.
* Patients who have been previously randomized into this study, or are presently participating in another clinical trial
* Patients who are currently receiving radiation therapy or chemotherapy.
* Patients with known or suspected local skin malignancy to the index diabetic ulcer.
* Patients on anticoagulant medication will as in any surgical procedure, be monitored According to the protocols employed at the enrolling center.
* Patients diagnosed with autoimmune connective tissues diseases.
* Nonrevascularable surgical sites
* Active infection at site
* Sensitivity to the following antibiotics: Gentamicin, Cefoxilin, Linocmycin, Polymyxin B, Vancomycin
* Any pathology that would limit the blood supply and compromise healing;
* Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01353495
Study Brief:
Protocol Section:
NCT01353495