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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT04537520
Eligibility Criteria:
Inclusion Criteria:
* Diabetic patients, regardless of the age of their diabetes, with a grade UT 2 or 3 lower limb sore; grade 2: wound penetrating to the tendon or capsule. UT grade 3: wound penetrating to the bone or joint OR hospitalized/ambulatory patients for diabetic foot sores or amputations, which have not closed or are dehiscent.
* Patients who can tolerate aggressive surgical debridement
* Patients without severe ischemia IPS - 0.6 or pressure of the big toe - 50mmHg
* Longness of the wound: 30 days (does not apply to amputation wounds; patients may be included when the wound is less than 30 days old) OR if the amputation level is under the ankle
* Patients willing and able to give informed consent to participate in the clinical trial.
* Male or female over the age of 18
* Patients living at a geographical distance compatible with referral nurse visits
* Negative pregnancy test for women of childbearing age who do not use contraception.
* Patients covered by social security
* Patients who are capable (in the investigator's opinion) and willing to comply with all clinical trial requirements
Exclusion Criteria:
* Patients whose wound surface is not measurable
* Patients with unsealed osteomyelitis
* Patients with fever related to a foot infection (it may be reassessed at a later time when the infection is gone)
* Patients with a necrotic wound that will not tolerate aggressive surgical debridement
* Immunosuppressed patients
* Patients with systemic corticosteroids or other treatments that may delay wound healing
* Pregnant, breast-feeding or planning pregnancy during the clinical trial
* Any other significant disease or disorder that the investigator believes may pose a risk to participants because of their participation in the clinical trial or that may influence the outcome of the clinical trial or the participant's ability to participate in the clinical trial.
* Patients with rheumatoid arthritis
* Patients with systemic lupus
* Patients with a known skin allergy to fish
* Patients deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04537520
Study Brief:
Protocol Section:
NCT04537520