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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07420868
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or above
* Either gender
* Chronic non healing cutaneous ulcer of at least 6 weeks duration
* Ulcer etiology eligible for conservative dressing-based management, including
* Diabetic foot, Venous leg and Pressure ulcer
* Other chronic ulcers considered suitable by the treating dermatologist
* Measurable index ulcer surface area suitable for standardized photography and planimetric assessment
* Clinically acceptable wound bed after initial wound bed preparation
* No requirement for urgent surgical reconstruction at enrolment
* Ability to attend twice weekly dressing visits for 6 weeks
* Provision of written informed consent
Exclusion Criteria:
* Suspected or proven malignant ulceration
* Vasculitic or inflammatory ulcers requiring systemic immunosuppression
* Pyoderma gangrenosum
* Critical limb ischemia or severe perfusion compromise on clinical assessment, with vascular screening where feasible
* Requirement for urgent revascularization
* Active osteomyelitis requiring bony debridement
* Exposed bone with high suspicion of osteomyelitis
* Rapidly spreading soft tissue infection
* Systemic sepsis
* Hematological abnormalities making venesection or platelet rich plasma preparation unsafe, including
* Clinically relevant platelet dysfunction
* Known bleeding diathesis
* Therapeutic anticoagulation where temporary interruption is not clinically appropriate
* Pregnancy or lactation
* Participation in another interventional wound trial
* Inability to comply with follow up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07420868
Study Brief:
Protocol Section:
NCT07420868