NCT01715012

Study of ST266 in Diabetic Subjects With Deep Burns Managed With Skin Grafts

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Noveome Biotherapeutics, formerly Stemnion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-01-01
• Completion: 2015-03-01
• First posted: 2012-10-26
• Last updated: 2019-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study