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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT06538168
Eligibility Criteria:
Inclusion Criteria:
* Presence of a diabetic foot wound corresponding to Warner 2 - 4 Continuous existence of the diabetic foot lesion for a minimum of 4 weeks \< Participant has given written informed consent
Exclusion Criteria:
* Age \<18 years Pregnancy Present or expected non-compliance with the requirements of the study estimated by investigator at the time point of inclusion indication for amputation above the ankle level of the same Necrotic tissue with eschar present that cannot be debrided untreated osteitis or osteomyelitis Unexplored fistula
* Malignancy of the wound Exposed nerves, vessels, or anastomotic areas
* Ambulant negative pressure wound therapy of patients with anticoagulation therapy or higher grade impaired clotting function and a heightened risk for bleeding with relevant circulatory effects
* Allergy to any disposal component of each treatment arm Severe anemia which is not caused by an infection
* Simultaneous participation in other interventional trials / previous participation in this trial
* Use of negative pressure wound therapy within 6 weeks before randomization
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06538168
Study Brief:
Protocol Section:
NCT06538168