Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing

A Randomized, Open-Label Trial Evaluating the Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing Compared to Matched Historical Controls Receiving Standard of Care

Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing

Inclusion Criteria.

1. Patient has signed the informed consent form.

2. Male or female patient at least 18 years of age or older, as of the date of the screening visit.

3. Confirmed diagnosis of Type 1 or Type 2 DM.

4. Has a DFU that is located below the malleoli ranging in size from 1.0 cm2 to 20.0 cm2, post debridement, when measured by the investigator staff at the screening visit using the eKare device.

5. The DFU has been present for ≥4 weeks and ≤12 months.

6. The DFU is non-healing as defined as <30% reduction in size in response to standard of care from Screening (Visit 1) to Study Day 1 (Visit 2).

7. If more than one ulcer is present the selected target ulcer must be at least 2 cm from the nearest edge of any adjacent ulcers.

8. The depth of the target foot ulcer is graded as Wagner Grade I or II, i.e., with no evidence of exposed muscle, tendon, bone, or joint capsule.

9. Arterial supply adequacy to the foot with the target ulcer confirmed by any one of the following and documented in medical record/EMR:

   1. Great toe pressure ≥ 40 mm/Hg
   2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.70 ≤ 1.20
   3. TcPO2 ≥ 30 mmHg from the foot
   4. Toe Brachial Index or TBI ≥ 0.65

10. Willing to follow all instructions given by the Investigator, return for all visits, and adhere to off-loading protocols while on the study.

Exclusion Criteria

1. Hemoglobin A1c (HbA1c) level is > 10%.
2. Chronic oral steroid use of > 7.5 mg daily within the previous 30 days preceding screening.
3. Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.
4. Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
5. Has malignancy or history of cancer in 5 years preceding the screening visit other than non- melanoma skin cancer.
6. Pregnant or lactating women.
7. Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
8. Currently on dialysis or planning to start dialysis.
9. Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
10. Has used wound treatments with enzymes, growth factors, living skin, dermal substitutes including other amniotic or umbilical cord tissue therapies, or other advanced biological therapies within the last 30 days.
11. Current use of topical anti-microbial or silver-containing products.
12. Target ulcer is over an active or inactive Charcot deformity.
13. The depth of the target ulcer is graded as Wagner Grade III or higher, i.e., with evidence of exposed muscle, tendon, bone, and/or joint capsule.
14. Gangrene is present on any part of the affected foot.
15. Current suspicion of osteomyelitis, cellulitis, or other clinical signs or symptoms of target ulcer infection.
16. Any previous use of human placental membrane applied to the target ulcer.