The objective of this protocol is to perform a safety and dose-determination efficacy clinical trial in patients having a degree of partial-thickness burn wounds. The trial will be a prospectively randomized and double-blind trial of ST266 compared with standardized care using 0.9% NaCl (normal saline) solution in the same three treatment regimens.
A Phase I/II multi-center clinical trial will be performed in 99 adults with partial-thickness burns. Two similar partial-thickness burn areas in a single patient will be selected. One burn will be randomly assigned to receive either test drug ST266 or normal saline in one of three treatment regimens. The three treatment arms will be: 1. ST266 0.01 mL/cm2 every 7th day vs. normal saline 0.01 mL/cm2 every 7th day; 2. ST266 0.01 mL/cm2 every 4th day vs. normal saline 0.01 mL/cm2 every 4th day; and 3. ST266 0.01 mL/cm2 every other day vs. normal saline 0.01 mL/cm2 every other day. Two different preclinical studies of partial-thickness burns on guinea pigs have demonstrated accelerated epithelialization with topical treatment with ST266. Similarly, preclinical studies in Yorkshire pigs have demonstrated more rapid maturity of epithelialization and better quality healing of partial-thickness skin graft donor sites with ST266 treatment. In the preclinical studies, ST266 given in a dose of 0.01 mL/cm2 wound area appeared to saturate the wound adequately without excess and simultaneously improve healing. In preclinical toxicity studies, the dose of 0.01 mL/cm2 was shown to be safe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
ST266 is a clear liquid containing more than 200 proteins, cytokines, and growth factors in solution. Patients will be treated for 21 days unless both wounds have healed prior to 21 days, at which time a punch biopsy of the epithelialized area of each wound will be performed. A study evaluation visit for assessment of the biopsy site will occur on day 28 or within 7 days of the punch biopsies, whichever occurs first. Six months after the punch biopsy, the patient will return to the burn center for a final examination and photographs of the study wounds.
University of South Alabama Dept. of Surgery
Mobile, Alabama, United States
LAC - USC Medical Center
Los Angeles, California, United States
The primary endpoint will be the percentage of each wound that has epithelialized during the 21-day treatment period comparing the ST266-treated wound with the saline-treated wound.
Time frame: 21 days
The number of totally epithelialized (100%) wounds in the ST266-treated wounds versus the number in the normal saline-treated wounds
Time frame: 21 days
The percentage conversion to full-thickness wounds in the ST266-treated wounds versus the conversion in the normal saline-treated wounds
Time frame: 21 days
Quality of healing, including pruritis, and scar hypertrophy, and reduction in pain in the ST266-treated wounds as compared to saline-treated wounds
Time frame: 21 days
Quality of healing as assessed by hemoxylin and eosin staining of the punch biopsy taken on Day 21 in the ST266-treated wounds as compared to saline-treated wounds
Time frame: 21 days
Assessment of change in arterial circulation using a laser Doppler from baseline to Day 21 in the ST266-treated wounds as compared to saline-treated wounds
Time frame: 21 days
Determination of levels of 6 cytokines present in blood prior to treatment (baseline) and within one-hour of the first treatment for the initial 12 patients
Time frame: 21 days
The primary safety endpoint will be the incidence of adverse events post-treatment.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Shands Burn Center at the University of Florida
Gainesville, Florida, United States
University of South Florida / Tampa General Hospital
Tampa, Florida, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Johns Hopkins Burn Center
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Missouri Health Care
Columbia, Missouri, United States
Acute & Critical Care Surgery Barnes Jewish Hospital, Washington University Medical Center
St Louis, Missouri, United States
...and 4 more locations