This trial will examine the feasibility of conducting a definitive randomized clinical trial that tests whether inforatio technique will reduce time to healing of diabetic foot ulcers. Inforatio technique is a procedure where small punch biopsies are taken from the wound bed near the edge of the wound. With this technique, the investigators wish to initiate an acute inflammatory response that increases the generation of granulation tissue with subsequent healing by scar formation. Thus, the investigators hypothesize that inforatio technique will promote healing of diabetic foot ulcers. Based on clinical experience, the investigators have previously detected a reduction in time to healing as an unexpected effect when multiple punch biopsies are taken from the wound bed of diabetic foot ulcers. To the knowledge of the investigators, methods similar to the inforatio technique has not previously been studied.
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Eligibility rates
Timeframe: The first 2 months of the trial (untill the last patient has been recruited)
Refusal rates
Timeframe: The first 2 months of the trial (untill the last patient has been recruited)
Time from identification to inclusion
Timeframe: The first 2 months of the trial (untill the last patient has been recruited)
Qualitative assessment of unexpected factors that must cause exclusion
Timeframe: 10 months
Rate of unexpected exclusion
Timeframe: 10 months
Retention rates
Timeframe: 10 months
Number of missed trial follow-up visits
Timeframe: 10 months
Drop-out rates
Timeframe: 10 months
Rate of eligible patients that accept participation
Timeframe: At baseline, each follow-up visit and when patients drop out.
Qualitative assessment of patient acceptability
Timeframe: 10 months
Observed harms and unexpected effects
Timeframe: 10 months
Patient-reported potential side effects
Timeframe: 10 months
Qualitative assessment of logistics issues regarding outpatient clinic visits
Timeframe: 10 months
Time to healing of punch biopsy scars
Timeframe: 10 months
Qualitative assessment of the method of wound assessment.
Timeframe: 10 months
Qualitative assessment of the extent of qualitative patient measures
Timeframe: 10 months
Qualitative assessment of the feasibility of culturing 3 biopsies from each round of inforatio technique applications for a future definitive trial.
Timeframe: 10 months
Rates of wound treatments at trial visits that deviate from the trial standard treatment definition
Timeframe: 10 months
Qualitative assessment of wound care treatments received between trial visits and the deviations from the trial definition of standard treatment.
Timeframe: 10 months
Time to healing of the foot ulcers
Timeframe: 10 months
Patient-reported experience of trial participation and the inforatio technique
Timeframe: 10 months
Staff acceptability
Timeframe: 10 months
Qualitative assessment of the inforatio technique
Timeframe: 5 months. At baseline application and at the 21-day applications.