Study of the Efficacy and Safety of Granexin® Gel to Improve Burn Wound Healing

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of Granexin® gel to promote accelerated healing of second-degree (deep partial thickness) thermal burns.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FirstString Research, Inc.
• Collaborator: United States Department of Defense

Criteria

Subjects will be eligible for randomization in the study if they meet all of the following inclusion criteria:

1. Aged 18 years or older

2. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and must agree to use hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence from the time of informed consent through Day 28 of the study; or female subjects must be postmenopausal (defined as 12 months since last menstruation) or surgically sterilized.

Male subjects must abstain from sex with WOCBP or use an adequate method of contraception (as described above) from the time of informed consent through Day 28 of the study.

3. Must have two comparable (similar body location, similar burn area and burn severity), noncontiguous deep second-degree thermal burns (target burns) caused by a fire/flame, scalds, or a hot object.

4. Must have two target burns:

1. No single target burn less than 1% TBSA

2. All burns less than 20% cumulative TBSA

5. Any treatment administered prior to randomization must be similar to both target burns and must be removed or discontinued prior to randomization.

6. Signed informed consent form

Subjects will not be eligible for randomization in the study if any of the following exclusion criteria are met:

1. Chemical, radiation, or electrical burns

2. Burns older than 36 hours prior to study randomization

3. Target burns more severe than deep second-degree

4. Target burns to the hands, face, neck, or feet. Burn area may include hands and feet where target burn will only include areas extending above the wrist or ankle.

5. Target burns that are superficial second-degree burn wounds expected to heal within two weeks

6. Evidence of active infection, including cellulitis, at the site of the target burns

7. Known collagen vascular diseases

8. Any history of malignancy within the last 5 years or the presence of any active systemic cancer (exception will be basal cell skin cancer in a non-burned area)

9. History of clinically significant cardio/pulmonary conditions

10. Clinically significant medical conditions as determined by the clinical Investigator, which would impair wound healing including renal, hepatic, hematologic, neurologic, or immune disease

11. Known inability or unavailability to complete required study visits

12. Critical illnesses such as those requiring ventilator support, or having a systemic infection or hemodynamic instability, defined as a mean arterial pressure less than 60 mm Hg or requiring vasoactive medications to support blood pressure

13. Major acute or chronic medical illnesses that could affect wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)

14. Currently receiving treatment with medications that inhibit or compromise wound healing. Examples include immunosuppressive agents, topical growth factors, therapeutic anticoagulants, antiplatelet drugs, and systemic steroids such as warfarin, clopidogrel, or prednisone. The use of anticoagulants does not include deep vein thrombosis (DVT) prophylaxis. Subjects may use aspirin or lovenox.

15. Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study

16. Clinically relevant serious co-morbid medical conditions including, but not limited to: unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active central nervous system (CNS) disease uncontrolled by standard of care

17. Known positive status for human immunodeficiency virus (HIV), or active hepatitis B or C, or cirrhosis

18. Psychiatric illness/social situations that would limit compliance with study requirements

19. Pregnant or breastfeeding

20. Treatment with another investigational drug within 30 days or 5 half-lives of drug prior to Screening, whichever is longer

21. Known hypersensitivity to the ingredients in Granexin® or ACTICOAT Flex 3TM

22. Known hypersensitivity or allergy to silver or polyester

23. Any other factor, which may, in the opinion of the Investigator, compromise participation and follow-up in the study.