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Study aim
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Determining the safety and feasibility of bi-layered allogenic cultured keratinocyte and fibroblast skin substitute application in the treatment of chronic diabetic foot ulcer
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Design
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In this first phase, single group, not randomized open-label clinical trial study, five patients will be enrolled in regular order according to standard protocols. The first patient will be monitored for one month, and if cell therapy is safe, the next patient will be Entered the study. Again, provided the treatment is safe during this period, the second and then the third patient will enter the study. In the absence of severe and life-threatening complications, subsequent patients will be included in the study.
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Settings and conduct
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Intervention site and patient visit: Diabetic foot ulcer clinic of Tehran University of Medical Sciences
Intervention: Debridement and skin substitute grafting to the dimensions of patients' wounds in the wound area
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with chronic diabetic foot ulcer on the plantar surface of the foot that is grade 2A in University of Texas score with the size of 2 to 20 cm2, that not treated despite two weeks of standard treatment, and with Conscious consent
Exclusion criteria: Pregnant patients, with weakened immune systems or uncontrolled underlying disease, evidence of infection, osteomyelitis, or gangrene
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Intervention groups
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The intervention group consisted of diabetic patients with chronic diabetic foot ulcers that receive skin substitute transplantation at the beginning and on the 14th day if the wound did not heal.
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Main outcome variables
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Evaluation of side effects, including short-term and long-term, systemic or local, severe or mild, and related and unrelated side effects of cell therapy at times 3, 7, 14, 18, 21, 28 days, and 6, 8, 12, 16, 20 and 24 weeks after the intervention