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 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT02131961
Eligibility Criteria:
Inclusion Criteria:
* Males or females between 18 and 80 years of age (inclusive) with diabetes type 1 or type 2
* Patients must sign an informed consent
* Diabetic medications must be stable for 4 weeks prior to randomization.
* Patients with a plantar ulcer
* Ulcer with an area between ≥ 1 cm2 and ≤ 10 cm2
* Patients must agree to comply with at least daily dressing changes and off-loading according to protocol requirements;
* Ulcer at least 6 weeks but not more than 12 months old
* Diabetic patients who use a medication to lower blood glucose levels who, in the opinion of the investigator, are considered "controlled" diabetics
* Adequate perfusion of the foot with the ulcer
* No prior use of Santyl on the target ulcer or treatment within one month with other bioactive therapies
Exclusion Criteria:
* Patients with more than two ulcers on the same foot
* Patients with ulcer requiring off-loading that cannot be effectively off-loaded
* Patients with ulcer above the plantar foot;
* Patient non-compliance with protocol-required off-loading and dressing change
* Patients with infected ulcers
* Patients with severe edema (defined as inability to fit leg into off-loading device);
* Patients with a gangrenous or ischemic toe that may need to be amputated in the opinion of the investigator;
* Patients with Buerger's disease, vasculitis or connective tissue disease;
* Ankle brachial index \>1.2 (ABI \>1.2 must be confirmed by another method such as Transcutaneous partial pressure oxygen (TcPO2) \> 40 mm Hg at the ankle or Toe pressure of \> 40mm Hg or Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic) or Skin Perfusion Pressure (SPP) \> 40 mm Hg);
* Patients with claudication
* Body mass index (BMI) \> 40 kg/m2
* There is active Charcot's joint by clinical or radiographic criteria.
* Unable or unwilling to provide informed consent.
* Known HIV infection and/or AIDS based on participant self-report.
* Patients with contraindication to contact casting (ie. peripheral vascular disease, Infection)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02131961
Study Brief:
Protocol Section:
NCT02131961