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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT01643967
Eligibility Criteria:
Inclusion Criteria:
* Consent form signed;
* Patients with Diabetes Mellitus Type I or Type II trophic lesions presenting in the lower limbs;
* Injury whose largest diameter is less than 5 cm;
* Patients of both sexes, aged above 18 years;
* Heart rate 60 to 100 bpm.
Exclusion Criteria:
* Presence of severe septic conditions;
* IMC \> 30;
* Presence of Lymphedema;
* Presence of trophic lesions in the lower limbs: exudative, traumatic and parasitic;
* Trophic lesions caused by venous disease requiring treatment;
* Hepatic or renal dysfunction;
* History of alcohol abuse and drugs in the last 6 months;
* Laboratory parameters:
* hemoglobin \< 10 g/dl;
* Glycated hemoglobin \> 9%;
* Diagnosis of hyperthyroidism (TSH \< 0.50 μUI/mL, free T4 \> 1.80 ng/dL);
* Deficit of Glucose 6 Phosphate Dehydrogenase (G6PD) \> 20%;
* Use of immunosuppressive drugs or anticonvulsants;
* Pregnant woman or lactating;
* Any significant medical condition which in the opinion of the Investigator may bring risks to the patient;
* Known hypersensitivity to drugs and/or treatments to be used in the study;
* Inability to compliance with the protocol;
* Participation in another clinical trial for less than 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01643967
Study Brief:
Protocol Section:
NCT01643967