Cellular Reprogramming-Enhanced Skin Grafting for Diabetic Foot Ulcers
China108 participantsStarted 2017-08-01
Plain-language summary
Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in clinical practice. This study was conducted to have a prospective, randomised, controlled study compare the safety and efficacy of the autologous skin cell with skin graft (experiment group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot ulcers.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. .Adults aged ≥18 years with type 1 or type 2 diabetes mellitus, diagnosed according to WHO criteria.
✓. .Presence of a chronic diabetic foot ulcer located below the ankle, classified as Wagner grade 2-3, with a post-debridement area of 5-80 cm².
✓. .Target ulcer present for ≥4 weeks and unhealed despite ≥4 weeks of standard wound care prior to randomization.
✓. .HbA1c \<12%, measured at screening or within 3 months prior to randomization.
✓. .Any revascularization of the affected limb completed ≥4 weeks before randomization.
✓. .Ability to provide written informed consent and comply with all study procedures and follow-up requirements.
Exclusion criteria
✕. .Active infection of the target ulcer requiring systemic antibiotics, or presence of non-removable necrosis, purulence, or sinus tracts.
✕. .Significant peripheral arterial disease, defined as ABI \<0.7 or \>1.3.
✕. .End-stage renal disease or eGFR \<20 mL/min/1.73 m².
✕. .Active malignancy, uncontrolled autoimmune disease, or current use of systemic immunosuppressive therapy.
✕. .Hematologic disorders that may impair wound healing.