Allogenic Dermis Versus Standard Care in the Management of Diabetic Foot Ulcers

This is a prospective, randomized, comparative, parallel group, Multi-center clinical trial
comparing the proportion of ulcers completely healed by use of allogenic dermal graft versus
the standard protocol of wound care in diabetic patients with a diabetic foot ulcer with
adequate arterial perfusion, for wound healing to the affected limb. The primary objective of
this study is to compare the proportion of ulcers completely healed by the allogenic dermal
graft protocol of care to the standard protocol of care in the management of indolent
diabetic ulcers at 6 weeks. The secondary objectives of this study are to compare the
proportion of healing at 4 weeks, 12 weeks and, the mean time to healing. Patient after
signing IRB approve informed consent, upon meeting inclusion/exclusion criteria will be
randomized into one of two group. One group receiving standard of care protocol, with an
offloading boot, and one group received human allogenic dermis application, with compressive
dressing and offloading boot. Patients will be seen weekly or until complete healing occurs.
Measurements will be taken of the diabetic ulcers using the a centimeter ruler measuring
length by width.

Inclusion Criteria:

1. Patients age 18 or older.

2. Patient is willing to provide informed consent and is willing to participate in all
procedures and follow up evaluations necessary to complete the study.

3. Patient's ulcer must be diabetic in origin and larger than 1 cm2.

4. Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes
mellitus per ADA).

5. Ulcer must be present for a minimum of four weeks before enrollment randomization,
with documented failure of conventional ulcer therapy to heal the wound.

6. A two week run-in period will precede enrollment/ randomization in the trial to
document the indolent nature of the wounds selected.

7. Additional wounds may be present but not within 3 cm of the study wound.

8. Wound must be present anatomically on the foot as defined by beginning below the
malleoli of the ankle and be neuropathic in origin.

9. Patient's ulcer must exhibit no clinical signs of infection.

10. Serum Creatinine less than 3.0mg/dl within last six months.

11. HbA1c less than or equal to 12% within last 90 days.

12. Patient has adequate circulation to the affected extremity, as demonstrated by one of
the following within the past 60 days:

1. Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg,

2. ABIs with results of ≥0.7 and ≤1.2, OR

3. Doppler arterial waveforms, which are triphasic or biphasic at the ankle of
affected leg.

Exclusion Criteria:

1. Patients presenting with an ulcer probing to tendon, muscle, capsule or bone (UT Grade
IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt
with a sterile, ophthalmological probe.

2. Patients whose index diabetic foot ulcers are greater than 25 cm2.

3. Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater
than 12% within previous 90 days.

4. Patients whose serum creatinine levels are 3.0mg/dl or greater within the last six
months.

5. Patients with a known history of poor compliance with medical treatments.

6. Patients who have been previously randomized into this study, or are presently
participating in another clinical trial.

7. Patients who are currently receiving radiation therapy or chemotherapy.

8. Patients with known or suspected local skin malignancy to the index diabetic ulcer.

9. Patients diagnosed with autoimmune connective tissues diseases.

10. Non-revascularizable surgical sites.

11. Active infection at site.

12. Any pathology that would limit the blood supply and compromise healing.

13. Patients that have received a biomedical or topical growth factor for their wound
within the previous 30 days.

14. Patients who are pregnant or breast feeding.

15. Patients who are taking medications that are considered immune system modulators which
could affect graft incorporation.

16. Patients with known hypersensitivity to components of any treatment used in the trial.

17. Wounds greater than one year in duration without intermittent healing.

18. Wounds improving greater than 20% over the first two weeks (run-in period) of the
trial using standard of care dressing and camboot.

19. Patients taking Cox-2 inhibitors.