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 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT03137966
Eligibility Criteria:
Inclusion Criteria:
* Chronic foot ulcer (\> 1month) (at or below the ankle) grade 1A, 2A (University of Texas Wound Classification System) with an ulcer area between 150-350 mm2.
* No ulcer should present a moderate or severe infection at baseline. Concomitant treatment with systemic antibiotics at baseline is accepted if all ulcers meet none of the criteria defining moderate or severe infection.
* Toe/brachial index \>0.6 and/or Tcp02 \>50mmHg or ankle/brachial index \>0.65, or the pulses at dorsalis pedis/tibialis posterioris clearly palpable.
* If more than one ulcer is present, the largest ulcers that fulfill inclusion criteria will be included
* Patient should be compliant to one of the accepted off-loading system.
* Patients will be able to provide written informed consent
Exclusion Criteria:
* Acute cardiovascular event (myocardial infarction/unstable angina, stroke) within three months prior to randomisation
* Subjects who have undergone vascular reconstruction or angioplasty less than 3 months prior to randomisation
* Decompensated congestive heart failure or functional class 3-4.
* Childbearing potential
* Impaired hepatic function (2 times upper normal limit of ASAT and ALAT)
* Severe renal failure (GFR calculated after Cockcroft's formula \<30 ml/min/1.73 m2)
* Ongoing treatment with immunosuppressive drugs
* HbA1c \>12 % (108 mmol/l)(12%)
* Polyglobulia (EVF\>0.60 men, EVF\> 0.56 women)
* Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol
* Malignancy other than basal-cell carcinoma and cervical carcinoma in situ, requiring any general, local, surgical or radiation therapy.
* History of alcohol or drug abuse
* Osteomyelitis defined as:
1. There is a clinical suspicion of osteomyelitis;
2. Ulcer considered for treatment is located at the site of a past amputation;
3. History of acute osteomyelitis in the past 90 days or history of recurrent osteomyelitis; or
4. A positive "probe to bone" test.
* Participant in another ongoing study
* Known hypersensitivity to deferoxamine
* Unwillingness to participate following oral and written information
* Subjects with any other severe acute or chronic medical or psychiatric condition that make the subject inappropriate for the study in the judgment of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03137966
Study Brief:
Protocol Section:
NCT03137966