Study of ST266 in Diabetic Subjects With Deep Burns Managed With Skin Grafts (NCT01715012) | Clinical Trial Compass
TerminatedPhase 2
Study of ST266 in Diabetic Subjects With Deep Burns Managed With Skin Grafts
Stopped: Enrollment futility
United States1 participantsStarted 2012-10
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed and dated Institutional Review Board-approved written Informed Consent
* 18 - 75 years of age.
* Thermal or scald burn, either full thickness or deep partial thickness, which in the opinion of the burn surgeon, requires a meshed skin graft to heal.
* Target burn area for treatment equal to or less than three percent total body surface area.
* A skin graft site harvested at 10/1000ths of an inch and a skin graft meshed at 2:1.
* Total Body Surface Area (TBSA) burn of less than or equal to 20 percent total body surface.
* Patient must have a known history of diabetes, or be found to have diabetes at the time of admission, confirmed by a Hemoglobin A1C of greater than 6.5 percent.
* If a woman of child-bearing potential (WOCBP), she and her partner must be willing to employ either a highly effective form of birth control (e.g., implants, injectable medications, a hormone combination oral contraceptive, etc.), sexual abstinence, or a vasectomised partner, in combination with a barrier method, for the entire duration of the study (through study discharge). Male subjects with a WOCBP partner must be willing to use a condom during sexual activity for the entire duration of the study (through study discharge).
* Willing to participate in the clinical study and comply with the requirements of the trial.
Exclusion Criteria:
* Full thickness burns involving tendon, ligament, bone, or joint capsule.
* Burns of the face, neck, palmer surface of the hands an…
What they're measuring
1
Safety
Timeframe: Beginning at enrollment and continuing 12 months after last treatment