This study is a randomized, double blind, placebo controlled trial at a single site. The primary objective is to evaluate the safety of ST266 in diabetic subjects with deep burns. The secondary objectives of this study are to (1) evaluate efficacy of ST266 in healing burns and (2) evaluate whether treatment with ST266 results in less scarring, in subjects with diabetes separately comparing healing of the skin graft and the skin graft donor site using ST266 plus a burn dressing versus placebo and a burn dressing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
The Burn Unit of the Wexner Medical Center at The Ohio State University.
Columbus, Ohio, United States
Safety
The primary objective of this study is to evaluate the safety of ST266 in treating burns in diabetic subjects by evaluating adverse events and serious adverse events. Physical examination, hematology, serum chemistry, urinalysis, vital signs, Adverse Event monitoring, and concomitant medications, cytokine and antibody levels will be monitored at baseline and during the study.
Time frame: Beginning at enrollment and continuing 12 months after last treatment
Healing of skin graft
Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing the time to complete healing of the skin graft.
Time frame: Up to 2 weeks of treatment
Healing of skin graft donor site
Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing the healing of the skin graft donor site.
Time frame: Up to 2 weeks of treatment
Scarring of skin graft
Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing scarring of the skin graft at six months and one year using a validated scar scale.
Time frame: One year following treatment
Scarring of skin graft donor site
Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing scarring of the skin graft donor site at six months and one year using a validated scar scale.
Time frame: One year following treatment
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