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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT01814267
Eligibility Criteria:
Inclusion Criteria:
* Patients with type 1 or 2 diabetes, at least 18 years old
* Patient with a diabetic foot wound :
* Acute or chronic (evolving for at least 30 days)
* size ≤ to 3 cm²
* Level I, II or III, stage A or B, excluding stages C and D from the University of Texas Wound Classification Systems
* Person affiliated to French Health insurance or equivalent
* Person having signed freely the consent form after receiving sufficient information
* Treatment compliance and 6 months follow-up feasible
Exclusion Criteria:
* Patient with a ischemic wound: Ankle-Brachial Index (ABI) \<0.9 or Transcutaneous oxygen pressure (TcpO2) \< 30 mmHg (stage C and D from the University of Texas Wound Classification Systems)
* Patient with emergency hospitalization indication whatever the reasons.
* Person deprived of liberty by a legal or administrative decision, patients in emergency and people hospitalised without consent and who are not protected by law.
* Pregnant or breastfeeding women
* Patient currently participating in another telemedicine research protocol (such as : Study on the impact of Telemedicine on the management of patients with type 1 diabetes (TELEDIAB-3))
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01814267
Study Brief:
Protocol Section:
NCT01814267