Study of ST266 in Diabetic Subjects With Deep Burns Managed With Skin Grafts
NCT01715012 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2019-05-15
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.
Conditions
- Third Degree Burns
- Diabetes
Interventions
- BIOLOGICAL
-
ST266
ST266 is applied daily by spray to burn wound and skin graft donor site
- DRUG
-
Saline
Saline is applied daily by spray to burn wound and skin graft donor site
Sponsors & Collaborators
-
Noveome Biotherapeutics, formerly Stemnion
lead INDUSTRY
Principal Investigators
-
Larry Jones, MD · Ohio State University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2015-01-31
- Completion
- 2015-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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