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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT00935051
Eligibility Criteria:
Inclusion Criteria:
* Patients with type 1 or type 2 diabetes
* Age over 40
* Chronic diabetic foot ulcer (duration over 30 days)
* Grade 1 to 3, stage A and C according to the University of Texas Wound Classification, except stage B and D
* Wound area over 0.5 cm²
* Social Security membership or benefit from Social Security
* Informed consent, with a signed and approved form
* Possibility to have clinical follow-up and compliance during 3 months
Exclusion Criteria:
* Urgent need for locoregional surgery
* Clinical criteria for infection, defined by the presence of pus or/and at least 2 local signs among the following: heat, erythema, lymphangitis, lymphadenopathy, oedema, pain
* Other pathology that could interfere with the healing process (vasculitis, connectivitis, dysimmunity, immunosuppressive treatment or corticoids, ongoing radiotherapy or chemotherapy )
* Any severe pathology that would constitute a contra-indication to the patient's inclusion
* Ongoing therapeutic research protocol
* Underage patient, major patient under guardianship or protected by the Law
* Pregnant, parturient or breastfeeding woman
* Person with no freedom (prisoner), person in an emergency situation, person hospitalized without consent and not protected by the Law
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00935051
Study Brief:
Protocol Section:
NCT00935051