Safety and Efficacy of GRANEXIN GEL plus Standard of Care in comparison to Standard of Care alone in the Treatment of Diabetic Foot Ulcer

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 92

Inclusion Criteria

1. Male or female aged 18 years and older.

2a. Female subjects must be post-menopausal or surgically sterilized.

or

2b. Female of child-bearing potential must have negative pregnancy test at screening, and agrees to use hormonal contraceptive or intra-uterine device (IUD) or diaphragm with spermicide or condom with spermicide or abstinence throughout the study.

3. Diabetes mellitus (type I or II) with an HbA1c < 10.0%.

4. Diagnosis of neuropathic foot ulcer.

5. Cutaneous, full thickness (University of Texas grade A1), below ankle surface ulcer between 0.5 cm2 and 40 cm2 post debridement.

6. A viable, granulating wound as per investigators discretion.

7. Ulcer present for at least 4 weeks prior to screening day.

8. An Ankle Brachial Index between 0.70 and 1.3 measured at screening.

9. Signed informed consent form.

Exclusion Criteria

1. Decrease or increase in the ulcer size by 30% or more during 7 day screening period.

2. Cannot tolerate the off-loading method or comply with standard of care.

3. An ulcer which shows signs of severe clinical infection, defined as pus oozing from the ulcer site.

4. The ulcer to be treated requires operative debridement.

5. An ulcer positive for _-hemolytic streptococcus upon culture.

6. Requirement for total contact casts.

7. The ulcer has more than 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure.

8. Highly exuding wounds (wounds that require a daily dressing change).

9. ABPI 0.7 or 1.3 or ankle systolic pressure 70 mm Hg.

10. Subjects with systemic infections.1

1. One of the following findings (only 1 out of 3 tests is required):

a. On Doppler waveform analysis on the dorsalis pedis and posterior tibial arteries monophasic or biphasic flow (with loss of reverse flow) in either foot artery, or

b. A toe: brachial index 0.7 or 1.3, or

c. Transcutaneous oxygen pressure (TcpO2) 40 mm Hg

12. Presence of an active systemic or local cancer or tumor of any kind (with the exception of nonmelanoma skin cancer).

13. Subjects with Congestive heart failure New York Heart Association class II to IV or Coronary heart disease with ST segment elevation myocardial infarction (STEMI) or Coronary Artery Bypass Graft (CABG) or Percutaneous Transluminal Coronary Angioplasty (PTCA) within the last 6 months.

14. Subjects with active osteomyelitis of the study foot.

15. Subjects with active connective tissue disease.

16. Subjects with Acute Charcots neuro-arthropathy as determined by clinical and/or radiographic examination.

17. Active treatment with systemic corticosteroids.

18. Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation.

19. Pregnant or nursing subjects.

20. Subjects with Uncontrolled anemia (Hb 10 g/dL in females and 12 g/dL in males).

21. Subjects with eGFR 25 mL/min.

22. Subjects with poor nutritional status defined as an albumin 25 g/L.

23. Subjects with significant peripheral edema as per Investigators discretion.

24. Known prior inability or unavailability to complete required study visits during study participation.

25. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the subjects medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance.

26. Use of a platelet-derived growth factor within the 28 days prior to screening.

27. Use of any investigational drug or therapy within the 28 days prior to screening.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean percent wound closure from baseline to 12 weeksTimepoint: The mean percent wound closure from baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Mean percent wound closure at 4 weeksTimepoint: at 4 weeks;Subject self-assessment of intensity of pain.Timepoint: during enitre study;Time taken for 50% wound closure.Timepoint: during enitre study;Time to complete wound closure where complete wound closure will be defined as 100% epithelialization of the wound and the absence of drainage from the woundTimepoint: during enitre study