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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT04154020
Eligibility Criteria:
Inclusion Criteria
* Patients aged 18 years or above
* Type 1 or 2 diabetes
* Hammer, mallet or claw toe deformity as judged by investigator
* Ulcer associated with above mentioned deformities
* Able to understand written and oral information
* Ability to follow planned visits and treatment
* Able to provide informed consent in Danish and/or English
Exclusion Criteria
* Revascularization procedure in the affected limb planned, or undertaken within the 4 weeks prior to screening
* Hammer, claw and mallet toe that are completely rigid in both MTP and IP joints
* Toe blood pressure lower than 30mmHg
* Infections of the foot ulcer needing surgical treatment
* Prior major amputations on affected or ipsilateral leg
* Other corrective operation is indicated to treat patients foot deformities as deemed by investigator
* Current treatment with cytotoxic drugs or with systemically administered glucocorticoids
* Treatment of foot ulcers with growth factors, stem cells or equivalent preparations within the 8 weeks prior to screening
* Likely inability to comply with the need for planned visits because of planned activity
* Participation in another interventional clinical foot ulcer-healing trial within the 4 weeks prior to screening
* Prior enrolment in this trial
* Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04154020
Study Brief:
Protocol Section:
NCT04154020