Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)

1. Males and females ≥ 18 years of age

2. Properly obtained written informed consent

3. Documented history of Type I or Type II Diabetes Mellitus, requiring oral and/or insulin replacement therapy

4. The index ulcer is classified as Wagner grade 1 ulcer and remains Wagner 1 Grade between Screening and Randomization/Baseline visit (Visit 1 through Visit 3)

5. These ulcers are superficial, full-thickness ulcers limited to the dermis, not extending to the subcutaneous tissue

6. Area of index ulcer must be between 1 cm2 to 15 cm2 post debridement at screening and baseline

7. The index ulcer must be located anatomically on the foot with ≥ 50% of the wound area below the medial or lateral malleolus

8. Presence of a persistent nonhealing DFU for at least 4 weeks from Randomization and not more than 1 year that has failed to respond to SOC at any point during this timeframe

9. Adequate vascular perfusion as evidenced by one of the following:

1. Dorsal transcutaneous oxygen measurement (TCOM/TcPO2) measurement of

≥ 40 mmHg within 90 days of Screening (Visit 1 or 2)

2. Ankle Branchial Index (ABI) between 0.7 and 1.3 within 90 days of Screening (Visit 1 or 2) using the extremity on which the index ulcer is located

3. Arterial Doppler ultrasound evaluating for biphasic or triphasic dorsalis pedis and/or posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable within 90 days of Screening (Visit 1 or 2)

10. The index ulcer has been offloaded with protocol defined offloading device during Screening (Run-In) period through Randomization/Baseline visit.

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 (Subject verbal confirmation acceptable), or surgically sterilized (i.e., hysterectomy or bilateral oophorectomy more than 3 months prior to Screening (Visit 1 or 2)), or ii. Bilateral tubal ligation more than 6 months prior to Screening (Visit 1 or 2), or iii. Must have a negative serum β-hCG pregnancy test at Visit 1 and not be breastfeeding prior to being administered with the study drug b. Male subjects of Non-Childbearing Potential are defined as those vasectomized subjects whose vasectomy was performed 6 months prior to Screening (Visit 1 or 2) 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.

Female will undergo a negative serum β-hCG pregnancy test at Visit 1 and an additional urine test at Baseline/Randomization (Visit 3 or Day 0) and must not be breastfeeding prior to being administered with the study drug

12. Ability to comply with the study protocol as per investigator discretion

Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)

What this study is about

Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)

What this study is about