Inforatio Technique to Promote Wound Healing of Diabetic Foot Ulcers (NCT05189470) | Clinical Trial Compass
CompletedNot Applicable
Inforatio Technique to Promote Wound Healing of Diabetic Foot Ulcers
Denmark100 participantsStarted 2022-03-10
Plain-language summary
This randomized clinical trial will examine the effect of inforatio technique on healing of diabetic foot ulcers (DFUs).
Inforatio technique is a novel procedure developed by the research group. The definition of inforatio technique is application of small cuts in wound beds with punch biopsy tools without involving surrounding epithelia. The aim is to initiate an acute inflammatory response that will promote healing of the ulcers.
Who can participate
Age range18 Years
SexALL
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INCLUSION CRITERIA
* Age ≥ 18 years
* Diabetes mellitus
* Non-surgical ulcer located distal to the malleoli
* Wound diameter \>4 millimeters
* Patient-reported wound duration ≥ 6 weeks
Only one ulcer will be included from each participant. If a patient has more than one eligible ulcer, the largest ulcer is included. In case of equally sized ulcers, the ulcer with the most recent onset is included.
EXCLUSION CRITERIA
* Dementia or other reasons that cause inability to give informed consent
* Malignant disease
* Current treatment with systemic immunosuppressive drugs.
Exclusion criteria related to the index extremity:
* Diagnosed with or awaiting evaluation of suspected acute phase Charcot arthropathy or osteomyelitis
* Non-palpable pulse in both arteria dorsalis pedis and arteria tibialis posterior accompanied by systolic toe pressure \<30 mmHg in the index foot.
* Amputation at midfoot level or proximal to midfoot level
* Revascularization procedure awaits or has been undertaken within the last 8 weeks or the patient awaits a vascular surgeons' decision on revascularization
* Gangrene
Exclusion criteria related to the index ulcer
* Infection of the ulcer defined according to IWGDF/IDSA (International Working Group on the Diabetic Foot/ Infectious Diseases Society of America system) classification as presence of at least 2 of the following; 1) local swelling or induration; 2) erythema \>0.5 to ≤2 cm around the ulcer; 3) local tenderness or pain; 4) local warmth; or 5) …