Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers

AutoloGel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds.
Prospective observational studies of the effectiveness of AutoloGel have demonstrated
promising results in regard to the healing of DFUs, including severe Wagner grade 3 and 4
ulcers. The aim of this trial is to demonstrate the effectiveness of complete wound healing
in a prospective, open-label, case-matched cohort trial in which diabetic foot ulcers will
be treated using AutoloGel to determine the time to heal at 12 weeks. Comparison will be
made with a case-matched concurrent cohort of patients receiving undefined Usual and
Customary Care (UCC).

Inclusion Criteria:

1. Medicare/Medicaid eligible

2. ≥18 years of age

3. Type I or II diabetes requiring medical treatment as determined by the physician

4. The largest non-healing wound, if multiple wounds are present, or the single wound to
be treated (Index Ulcer) is a Wagner 1-5 DFU (see Appendix 9 for Wagner
Classification) that is located on the dorsal, plantar, medial, or lateral aspect of
the foot or heel (including all toe surfaces)

5. For subjects with potentially multiple eligible DFUs, the largest ulcer will be
selected There must be at least 4 cm between the Index Ulcer and other ulcers; if all
ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)

6. Debrided ulcer size between 0.5 cm2 and 50 cm2

7. Demonstrated adequate offloading regimen

8. Duration ≥ 1 month at first visit

9. Subject must be willing to comply with the Protocol, which will be assessed by
enrolling clinician.

Exclusion Criteria:

1. Subjects known to be sensitive to AutoloGel components (calcium chloride, thrombin,
ascorbic acid) and/or materials of bovine origin

2. Presence of another wound that is concurrently treated and might interfere with
treatment of the index wound by AutoloGel (malignancy in nearby wound)

3. Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid,
collagen vascular disease, pressure, or arterial etiology)

4. Any malignancy other than non-melanoma skin cancer

5. Subjects who are cognitively impaired and do not have a healthcare proxy

6. Serum albumin of less than 2.5 g/dL

7. Plasma Platelet count of less than 100 x 109/L

8. Hemoglobin of less than 10.5 g/dL

9. Subject has inadequate venous access for repeated blood draw required for AutoloGel
Administration.