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

NCT01715012 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: ST-03-12
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Third Degree Burns; Diabetes

Keywords

Burn; Diabetes; Skin graft; Donor site

Outcome Measures

Primary Outcomes (1)

• Safety

  The primary objective of this study is to evaluate the safety of ST266 in treating burns in diabetic subjects by evaluating adverse events and serious adverse events. Physical examination, hematology, serum chemistry, urinalysis, vital signs, Adverse Event monitoring, and concomitant medications, cytokine and antibody levels will be monitored at baseline and during the study.

  Beginning at enrollment and continuing 12 months after last treatment

Secondary Outcomes (4)

• Healing of skin graft

  Up to 2 weeks of treatment

• Healing of skin graft donor site

  Up to 2 weeks of treatment

• Scarring of skin graft

  One year following treatment

• Scarring of skin graft donor site

  One year following treatment

Study Arms (2)

ST266

EXPERIMENTAL

ST266 sprayed to the skin graft and donor site

Biological: ST266

Saline

PLACEBO COMPARATOR

Saline (placebo)sprayed to the skin graft and donor site

Drug: Saline

Interventions

ST266 BIOLOGICAL

ST266 is applied daily by spray to burn wound and skin graft donor site

ST266

Saline DRUG

Saline is applied daily by spray to burn wound and skin graft donor site

Also known as: Placebo

Saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated Institutional Review Board-approved written Informed Consent
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Noveome Biotherapeutics, formerly Stemnion: lead

Study Sites (1)

The Burn Unit of the Wexner Medical Center at The Ohio State University.

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Burns

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Larry Jones, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 26, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)