Clinical trial NCT01715012: Study of ST266 in Diabetic Subjects With Deep Burns Managed With Skin Grafts
Official title: A Phase 2a Randomized, Double Blind, Placebo Controlled, Single-center Study of ST266 Spray in Diabetic Subjects With Deep Burns Managed With Meshed Skin Grafts.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Third Degree Burns
Diabetes
Keywords: Burn
Diabetes
Skin graft
Donor site
Lead sponsor: Noveome Biotherapeutics, formerly Stemnion
Sponsor class: INDUSTRY
First posted: 2012-10-26
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 and plantar surface of the foot.
* Burn from chemical, electrical or radiation causes.
* Subjects with any immune deficiency including current treatment with corticosteroid medication, chemotherapeutic agents, anti-viral therapy, or concurrent radiation therapy within 30 days of signing the informed consent.
* Active cancer or a history of cancer in the five years prior to signing the informed consent form. (History of basal cell carcinoma is allowed).
* Life expectancy of less than one year.
* Patients requiring care in the Intensive Care Unit.
* Inhalation injury requiring mechanical ventilation.
* Multiple trauma (significant traumatic injury to a solid organ in addition to skin).
* Psychiatric condition or substance abuse which in the Investigator's opinion may pose a threat to subject compliance.
* History of non-compliance with treatment or clinical visit attendance.
* Participation in an investigational trial within 30 days of study entry.
* Women who are pregnant or lactating
* Prisoners
* Acute clinically significant infection (including viral infections) in the six weeks prior to administration of study drug or any clinically significant ongoing chronic infection (excluding fungal infections of the nail beds).
* Evidence or history of skin conditions that would interfere with evaluations.
* Any other uncontrolled concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to individuals in this study or interfere with the interpretation of study data.

Primary outcomes:
measure: Safety
timeFrame: Beginning at enrollment and continuing 12 months after last treatment
Secondary outcomes:
measure: Healing of skin graft
timeFrame: Up to 2 weeks of treatment
measure: Healing of skin graft donor site
timeFrame: Up to 2 weeks of treatment
measure: Scarring of skin graft
timeFrame: One year following treatment
measure: Scarring of skin graft donor site
timeFrame: One year following treatment
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Burn Unit of the Wexner Medical Center at The Ohio State University.
state: Ohio
Study officials:
affiliation: Ohio State University
name: Larry Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: