Inforatio Technique to Promote Wound Healing of Diabetic Foot Ulcers
A legfontosabb adatok
- Ki végzi
- Zealand University Hospital
- Hol
- Dánia4 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 100 fő vett részt
- Kezdés
- 2022. márc. 10.
- Befejezés
- 2025. aug. 14.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- Inforatio technique
- Usual care of the respective outpatient clinics
- A regiszteradat frissítve
- 2026. március 25.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 18 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Current treatment with systemic immunosuppressive drugs
- Dementia or other reasons that cause inability to give informed consent
- Malignant disease
- 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) purulent discharge. Current antibiotic treatment due to infection of the index ulcer will also be considered as an ongoing infection regardless of presence of clinical signs of infection
- Interdigital ulcer location
- 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
- Positive probe-to-bone test
- Exposed joint or tendon
- The soft tissue layer covering bone or joint is evaluated to be too thin to allow for inforatio technique anywhere in the wound bed
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
This randomized clinical trial will examine the effect of inforatio technique on healing of diabetic foot ulcers (DFUs).
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- Control groupEgyéb csoport
These participants will receive the usual care of the respective outpatient clinics.
Kezelés: Usual care of the respective outpatient clinics
- Intervention groupA vizsgált kezelés
Participants that are randomized to the intervention group will receive both inforatio technique and usual care. Inforatio technique will be applied at baseline, 3, 6, 9 and 12 week- follow-up as long as the ulcers have a diameter of minimum four mms and have not developed infection, necrosis, positive probe-to-bone test, exposure of joint or tendon; or underlying osteomyelitis. In addition, inforatio technique will not be applied on ulcers that are covered by scab if the wound care staff assess that the scab should not be removed from the ulcer.
Kezelés: Inforatio technique és Usual care of the respective outpatient clinics
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Inforatio Technique to Promote Wound Healing of Diabetic Foot Ulcers: a Parallel-group, Evaluator-blinded, Randomized Clinical Trial
- Publikációk
- A regiszteradat frissítve
- 2026. március 25.