Third Degree BurnsPhase 2NCT01715012
Study of ST266 in Diabetic Subjects With Deep Burns Managed With Skin Grafts
A Phase 2 study testing ST266 and Saline in people with Third Degree Burns and Diabetes, run by Noveome Biotherapeutics, formerly Stemnion at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Third Degree Burns, Diabetes
- What is being tested?
- ST266 and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Mar 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Burn Unit of the Wexner Medical Center at The Ohio State University.
Columbus, Ohio, 43210
About this study
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.
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
- Being tested
- ST266, Saline
- Keywords
- Burn, Diabetes, Skin graft, Donor site
- Medical subject headings
- Diabetes Mellitus, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST266Biological
ST266 is applied daily by spray to burn wound and skin graft donor site
SalineDrug
Also called Placebo
Saline is applied daily by spray to burn wound and skin graft donor site
| Study group | Role | What they receive |
|---|---|---|
| ST266 | Experimental | ST266 sprayed to the skin graft and donor site Receives: Biological: ST266 |
| Saline | Placebo comparator | Saline (placebo)sprayed to the skin graft and donor site Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Beginning at enrollment and continuing 12 months after last treatment
Secondary outcomes (4)
Healing of skin graft
Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing the time to complete healing of the skin graft.
Measured: Up to 2 weeks of treatment
Healing of skin graft donor site
Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing the healing of the skin graft donor site.
Measured: Up to 2 weeks of treatment
Scarring of skin graft
Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing scarring of the skin graft at six months and one year using a validated scar scale.
Measured: One year following treatment
Scarring of skin graft donor site
Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing scarring of the skin graft donor site at six months and one year using a validated scar scale.
Measured: One year following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2015
- Study completionMar 2015
Why it stopped: Enrollment futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Degree BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noveome Biotherapeutics, formerly Stemnion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry Jones, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715012
- Sponsor's protocol ID
- ST-03-12
- Status last verified
- May 2019
- First submitted
- 22 Oct 2012
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01715012
- Acronym / sponsor ID
- ST-03-12
- Conditions
- Third Degree Burns, Diabetes
- Keywords
- Burn, Diabetes, Skin graft, Donor site
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment futility
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Noveome Biotherapeutics, formerly StemnionIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ST266 | Experimental | Biological: ST266ST266 sprayed to the skin graft and donor site |
| Saline | Placebo comparator | Drug: SalineSaline (placebo)sprayed to the skin graft and donor site |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST266ST266 is applied daily by spray to burn wound and skin graft donor site | Biological | ST266 |
| SalineAlso: PlaceboSaline is applied daily by spray to burn wound and skin graft donor site | Drug | Saline |
Primary outcome
Safety
Time frame: Beginning at enrollment and continuing 12 months after last treatment
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.
4 secondary outcomes
Healing of skin graft
Time frame: Up to 2 weeks of treatment
Healing of skin graft donor site
Time frame: Up to 2 weeks of treatment
Scarring of skin graft
Time frame: One year following treatment
Scarring of skin graft donor site
Time frame: One year following treatment
Results and safety
The study was stopped early (reason given: Enrollment futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry Jones, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ST266 and Saline in people with Third Degree Burns and Diabetes, run by Noveome Biotherapeutics, formerly Stemnion at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Beginning at enrollment and continuing 12 months after last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.