Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care

Not Applicable

Not yet recruiting

• Conditions: Diabetic Foot Ulcer; Diabetic Foot; Foot Ulcer; Ulcer Foot

• Registration Number: NCT06564831
• Lead Sponsor: Applied Biologics, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Subjects must be at least 18 years of age or older,<br><br> 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.<br><br> 3. At randomization subjects must have a target ulcer with a minimum surface area of<br> 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.<br><br> 4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52<br> weeks of standard of care prior to the initial screening visit.<br><br> 5. The target ulcer must be located on the foot with at least 50% of the ulcer below<br> the malleolus.<br><br> 6. The target ulcer must be Wager 1 or 2 grade, extending at least through the dermis<br> or subcutaneous tissue and may involve the muscle, provided it is below the medial<br> aspect of the malleolus. The ulcer may not include exposed tendon or bone.<br><br> 7. The affected limb must have adequate perfusion confirmed by vascular assessment. Any<br> of the following methods performed within 3 months of the first screening visit are<br> acceptable:<br><br> 1. ABI = 0.7 and = 1.3;<br><br> 2. TBI = 0.6;<br><br> 3. TCOM = 40 mmHg;<br><br> 4. PVR: biphasic.<br><br> 8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The<br> largest ulcer satisfying the inclusion and exclusion criteria will be designated as<br> the target ulcer.<br><br> 9. The subject must consent to using the prescribed off-loading method for the duration<br> of the study.<br><br> 10. The subject must agree to attend the weekly study visits required by the protocol.<br><br> 11. The subject must be willing and able to participate in the informed consent process.<br><br>Exclusion Criteria:<br><br> 1. A subject known to have a life expectancy of < 6 months is excluded.<br><br> 2. The subject is excluded if the target ulcer is not secondary to diabetes.<br><br> 3. If the target ulcer is infected or if there is cellulitis in the surrounding skin,<br> the subject is excluded.<br><br> 4. If there is evidence of osteomyelitis complicating the target ulcer, the subject is<br> excluded.<br><br> 5. A potential subject cannot have an infection in the target ulcer or in a remote<br> location that requires systemic antibiotic therapy.<br><br> 6. A subject receiving immunosuppressants (including systemic corticosteroids at doses<br> greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is<br> excluded.<br><br> 7. The topical application of steroids to the ulcer surface within one month of initial<br> screening is not permitted.<br><br> 8. A subject with a previous partial amputation on the affected foot is excluded if the<br> resulting deformity impedes proper offloading of the target ulcer.<br><br> 9. The potential subject has a glycated hemoglobin (HbA1c) greater than or equal to 12%<br> within 3 months of the initial screening visit.<br><br> 10. The subject is excluded if the surface area of the target ulcer has reduced in size<br> by more than 20% in the 2 weeks prior to the initial screening visit (historical<br> run-in period). Photographic planimetry is not required for measurements taken<br> during the historical run-in period (e.g. calculating surface area using length x<br> width is acceptable).<br><br> 11. The subject is excluded if the surface area measurement of the Target ulcer<br> decreases by 20% or more during the 2-week screening phase: the 2 weeks from the<br> initial screening visit (S1) to the TV-1/randomization visit during which time the<br> subject received SOC.<br><br> 12. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes<br> proper offloading of the target ulcer is excluded.<br><br> 13. Women who are pregnant or considering becoming pregnant within the next 6 months are<br> excluded.<br><br> 14. A potential subject with end stage renal disease requiring dialysis is excluded.<br><br> 15. A subject who, in the opinion of the investigator, has a medical or psychological<br> condition that may interfere with study assessments is excluded.<br><br> 16. A Subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product<br> (CTP) in the 30 days prior to the initial screening visit is excluded.<br><br> 17. The potential subject has a malnutrition indicator score <17 as measured on the Mini<br> Nutritional Assessment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of target ulcers achieving complete wound closure in 12 weeks.

Secondary Outcome Measures

Name	Time	Method
The time to heal for target ulcers.;Wound Area Reduction;Adverse Events;Change in pain in the target ulcer;Change in quality of life