Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)

A Multicenter, Randomized Trial Evaluating Dehydrated Human Placenta Tissue (dHPT) and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers

The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.

Chronic wounds affect a significant percentage of patients over their lifetime. For example, diabetic foot ulcers (DFU) are a major health complication that affect up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of chronic wounds is extremely challenging as ulcers such as DFUs may not respond to standard of care (SOC) treatment and frequently become infected.

Advanced wound products like Dehydrated Human Placental Tissue (dHPTs) have become an important strategy in the treatment of these chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.

This study will evaluate the clinical utility of Amnion-Intermediate-Chorion (AIC) in the closure of diabetic foot ulcers in subjects in comparison to Standard of Care treatment.

Inclusion Criteria:

Subjects will be eligible to participate in the study if the following conditions exist:

Inclusion Criteria:

1. 18 years of age or older.

2. Diagnosis of type 1 or 2 Diabetes mellitus.

3. Hemoglobin A1c (HbA1c) level is < 12% (108 mmol/mol).

4. Target ulcer with a surface area at randomization of 0.7 cm2 to 20.0 cm2 measured post debridement.

5. Target ulcer present for minimum of 4 weeks prior to screening visit.

6. Target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.

7. Target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.

8. Affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the screening visit are acceptable:

   1. ABI ≥ 0.7 and ≤ 1.3;
   2. TBI ≥ 0.6;
   3. TCOM ≥ 40 mmHg;
   4. PVR: biphasic or triphasic.

9. Subject with two or more ulcers must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.

10. Subject must consent to using the prescribed off-loading method for the duration of the study.

11. Subject must agree to attend study visits required by the protocol.

12. Subject must be willing and able to participate in the informed consent process.

Exclusion Criteria:

Subjects will be excluded from participation in the study if any of the following conditions exist:

1. Known life expectancy of < 6 months.
2. Target ulcer is not secondary to diabetes.
3. Target ulcer is infected or there is cellulitis in the surrounding skin.
4. Evidence of osteomyelitis complicating the target ulcer.
5. Infection in the target ulcer or a location that requires systemic antibiotic therapy.
6. Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
7. Topical application of steroids to the ulcer surface within one month of screening.
8. Previous partial amputation on the affected foot if the resulting deformity impedes proper offloading of the target ulcer.
9. Surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to screening visit ("historical" run-in period). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
10. Mini Nutritional Assessment (MNA) score of less than 17.
11. Acute Charcot foot or an inactive Charcot foot that impedes proper offloading of the target ulcer.
12. Women of childbearing potential (WOCBP) who are pregnant, considering becoming pregnant within the next 4 months, or are unwilling to use an appropriate form of contraception.
13. Currently require dialysis or planning to start dialysis.
14. Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.
15. Treated with hyperbaric oxygen therapy or a dehydrated human placental tissue (dHTP) in the 30 days prior to screening visit.
16. Known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.