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 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT05953935
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Agree to participate in the study and sign the informed consent form.
* Inpatients or outpatients who can be followed by the research team for the duration of the study
* Ulcers with a surface area of no less than 0.5 cm2 and of at least 4 weeks' duration (CDH), located on the lower limbs in the case of ulcers of venous etiology or on the foot, in the case of diabetic foot ulcers.
* For patients with ulcers of venous etiology: ulcers of venous etiology stage 2, 3 4 with diagnosis of chronic venous insufficiency with open wound CEAP IVC C6 according to CEAP classification (38).
* For patients with diabetic foot ulcers presenting:
* Type 1 and type 2 diabetics with a glycated hemoglobin (HbA1c ≤10% (in a test no longer than 3 months).
* Patients with UPD without PAD or with associated mild or moderate stage PAD (39) according to the criteria of the intersociety consensus for the treatment of peripheral arterial disease (TASC II).
* UPD Grade 1A, 1C, 2A, 2C according to the Texas classification (40).
* Patients who have required previous surgical debridement and 4 weeks have elapsed since such debridement.
* Comorbidity is defined as the presence of at least one of the following criteria:
* Smoking more than 10 cigarettes per day in the last 6 months.
* Immunosuppression: systemic treatment with high-dose corticosteroids in the previous 3 months, severe active infection in the previous month, presence of systemic or organ-specific autoimmune disease.
* Renal failure with creatinine \> 2 mg/dl.
* Respiratory failure with pO2\< 90 mm Hg
* Cardiac failure, grade II or higher
* Anemia or nutritional deficit
* Endocrine disruption under medical treatment
* Neuropathy in the affected area or neurological disease.
* Connective tissue diseases
* Mobility impairment
* Presence of microvascular disease
Exclusion Criteria:
* Pregnancy
* Patients with contraindications for CRET treatments (electronic implants, thrombophlebitis).
* Patients with chronic or pathological wounds that required surgical intervention.
* Ulcers with active infection according to IDSA classification in soft tissues or with clinical and/or radiological signs compatible with osteomyelitis.
* Allergies to standard wound treatment.
* Patients presenting severe renal insufficiency (Glomerular filtration rate ≤30 ml/min in analysis performed in the last 3 months).
* Patient who has presented an acute ischemic event (acute myocardial infarction or stroke, in the 3 months prior to inclusion in the study).
* Patients who present an evolving neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressants at the current moment.
* Patients treated for a chronic condition requiring the intake of strong systemic corticosteroids doses ≥ 40 mg prednisone).
* Critical non-revascularizable ischemia or TcPO2 \< 25mmHg or a digital hallux systolic pressure \< 50 mm Hg in diabetic foot ulcers.
* Patients who do not accept to use the prescribed unloading treatment in the case of diabetic foot ulcers.
* In the case of patients with ulcers of venous etiology, the presence of peripheral arterial disease in any of its stages.
* Patients who do not accept the indicated compressive bandage treatment, in the case of ulcers of venous etiology.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05953935
Study Brief:
Protocol Section:
NCT05953935