| Eligibility |
Inclusion Criteria:
1. Men and women at least 18 years of age and up to 80 years of age, inclusive.
2. Voluntary written consent, given before performance of any clinical
investigation-related procedure, and with the understanding that consent may be
withdrawn at any time without prejudice to future medical care.
3. Non-hospitalized ambulatory subjects suffering from diabetes mellitus, Type I or II
per ADA criteria.
4. The target ulcer is classified as grade 1 ulcer according to a Wagner Scale. These
ulcers are superficial, full-thickness ulcers limited to the dermis, not extending to
the subcutis.
5. Target ulcer is between 2 and 10 cm2 post debridement at screening and baseline.
6. The target ulcer must be no higher than the ankle (on or below the malleolus (ankle
bone) with =50% below the malleolus.
7. Presence of a persistent cDFU for at least 4 weeks and not more than 1 year that has
failed to respond to standard of care.
8. Adequate vascular perfusion as evidenced by one of the following:
1. Dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure
(SPP) measurement of = 40 mmHg.
2. Ankle Branchial Index (ABI) between 0.7 and 1.3 within 3 months of Screening
using the extremity with the target ulcer.
3. Arterial Doppler ultrasound evaluating for biphasic or triphasic dorsalis pedis
and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial
Index) of > 0.6 is acceptable.
9. Subject has a caregiver who is able to attend baseline visit and apply wound treatment
and study dressings for the study duration.
10. Subject completed protocol-defined standardized wound care during the Screening and
Run-in periods leading up to Day 0.
11. Must meet one of the following criteria:
a. Female subjects of Non-Child-Bearing Potential defined as: i. Postmenopausal for at
least 1 year, or surgically sterilized (i.e., hysterectomy or bilateral oophorectomy
more than 3 months prior to Screening), or ii. Bilateral tubal ligation more than 6
months prior to Screening iii. Must have a negative serum ß-hCG pregnancy test at
screening and not be breastfeeding prior to being administered with the study drug.
b. Male subjects of Non-Childbearing Potential defined as those vasectomized subjects
whose vasectomy was performed 6 months prior to Screening or those diagnosed as
sterile by a physician.
c. Females and Males of Childbearing Potential who practice an acceptable method of
contraception defined as the use of any form of hormonal contraceptive, a barrier
method with spermicide, condoms, intrauterine device, or abstinence from sexual
intercourse starting at least 60 days prior to Screening and continuing at least 30
days following the last treatment.
12. Subjects must be willing to undergo all clinical investigation-related procedures and
attend all required visits.
Exclusion Criteria:
1. Ulceration with exposed tendon, capsule, or bone.
2. Suspicion of bone or joint infection by clinical or other criteria.
3. Unable or unwilling to utilize the standardized offloading RCW as required per
protocol.
4. Target ulcer has decreased in area by =30% between Screening (V1) and Baseline (V3)
visits.
5. Any subject that is currently on/requires oral, systemic or topical antibiotics, or is
anticipated to require use during the course of the trial.
6. Any subject that has vascular compromise requiring surgical intervention or has
undergone vascular reconstruction or angioplasty less than 1 month prior to
randomization. Any planned surgical procedures during the study participation.
7. Serum Creatinine level >3.0 mg/dL.
8. Hemoglobin A1c (HbA1c) >12%.
9. Aspartate Aminotransferase (AST, GOT) and/or Alanine Aminotransferase (ALT, GPT) >3x
the upper limit of normal.
10. Acute active Charcot foot.
11. The target ulcer is within 3 cm of any other ulcer.
12. Any subject that would be unable to safely monitor the infection status at home, and
return for scheduled visits.
13. History of immunosuppression or taking immunosuppressive agents including systemic
corticosteroids, except stable daily doses of 5 mg/day or less for chronic conditions.
14. Any subject with a life expectancy = 6 months.
15. Pregnancy, including a positive pregnancy test at Screening or Baseline, or lactation.
16. Use of investigational drugs within 28 days prior to screening.
17. History of concurrent condition that, in the Investigator's opinion, would jeopardize
the safety of the subject or compliance with the protocol.
18. Likely inability to comply with the protocol or cooperate fully with the investigator
and site personnel.
19. Known or suspected active abuse of alcohol, narcotics, or non-prescription drugs.
20. Prior randomization in this clinical trial, or a previous Bisphosphocin study.
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