Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner gd 1 and 2 Diabetic Foot Ulcers.

Autologel is a platelet-rich plasma gel used in the treatment of no-healing chronic wounds.
Prospective observational studies of the effectiveness of Autologel have demonstrated
promising results in regard to the healing of diabetic foot ulcers including severe Wagner
grade 3 and 4 ulcers. The aim of the current trial is to compare the efficacy, measured as
wound healing in a single-blind (assessor) randomized controlled trial, of usual and
customary care with and without Autologel in treating Wagner 1 and 2 diabetic foot ulcers.

Inclusion Criteria:

1. Medicare 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 or 2 Diabetic Foot Ulcer (DFU; see Appendix 9
for Wagner Classification) that is located on the plantar, medial, or lateral aspect
of the foot (including all toe surfaces but not on the heel). Subjects who have heel
ulcers may be included if another, eligible wound is the index ulcer

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 20 cm2

7. Demonstrated adequate offloading regimen

8. Duration ≥ 1 month at first visit (screening period)

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. Wagner 3, 4, or 5 DFU (see Appendix 9 for Wagner Classification) Page 15 of 58

3. Any clinically infected index ulcer that is apparent on Day 0. The presence of
infection is defined by ≥ 2 classic findings of inflammation (erythema, warmth,
tenderness, pain, or induration) or purulent secretions (Lipsky, 2012, or see
Appendix 4)

4. Presence of another wound that is concurrently treated and might interfere with index
wound

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

6. Presence of underlying osteomyelitis, or if osteomyelitis is suspected

7. Received systemic corticosteroids or immunosuppressive agents, hyperbaric oxygen
therapy (HBOT), electrostimulation, growth factors, or any cell or tissue-derived
products for wounds during the 30 days preceding the screening visit; received
radiation therapy or chemotherapy within previous 6 months

8. Any malignancy other than non-melanoma skin cancer

9. Ischemic ulcer defined as an ankle brachial index (ABI; handheld or Arterial Doppler)
< 0.8 (note: if ABI is ≥ 1, then an skin perfusion pressure (SPP) or transcutaneous
oximetry (TCOM) must be performed or the subject cannot be enrolled), TCOM < 30 mm
Hg, or SPP < 30 mm Hg; toe pressure < 45 mm Hg. These measurements may be concurrent
with the initial evaluation of the index ulcer or obtained within 90 days of study
enrollment if done prior to that concurrence.

10. Subject has radiographic evidence consistent with diagnosis of active Charcot foot

11. Untreated Charcot foot or DFUs associated with a treated Charcot deformity in which
reconstruction or offloading has not taken place

12. Ulcer expected to be treated with any advanced therapeutics (e.g., HBOT)

13. Ulcer area decreases by ≥ 30% during 2-week screening/run-in period

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

15. Serum albumin of less than 2.5 g/dL

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

17. Hemoglobin of less than 10.5 g/dL

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

19. Subject requires or is anticipated to require interventions directed at improvement
of arterial perfusion to affected area.