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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT03483467
Eligibility Criteria:
Inclusion Criteria:
* Patients with diabetes (according to WHO criteria) aged 18 years or over
* At least one full thickness ulcer below the malleolus of either foot, present for 4 weeks or more.
* At least one palpable pulse on the foot of the index limb or an ABPI \>0.9
* Minimum ulcer diameter of 5 mm
* Maximum ulcer diameter of 20 mm.
* Able to attend clinic on a fortnightly basis
Exclusion Criteria:
* eGFR \<20
* HbA1c \>108
* Planned revascularisation during the course of the study or within the 4 weeks preceding the start of the study
* An ulcer of aetiology other than diabetes
* Depth of ulcer to bone, suspected or confirmed osteomyelitis
* Severe infection of the index ulcer
* Active Charcot of the foot of the index ulcer
* The need for negative pressure wound therapy
* On treatment with systemic steroids at a dose \> equivalent of 5mg prednisolone for more than 5 days and/or systemic cytotoxic agents
* Unwilling or unable to attend all trial visits.
* Unwilling or unable to give written informed consent.
* Lacks the mental capacity to give consent
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, may influence the result of the trial or the participant's ability to participate in the trial
* Participants who have participated in another research trial involving a wound healing product within the past 12 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03483467
Study Brief:
Protocol Section:
NCT03483467