Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers

Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Age Range:18 - Any
Start Date:September 2012
Contact:Charles M Zelen, DPM

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A Prospective, Randomized, Comparative Study of Amniotic Membrane Wound Graft With Weekly Versus BiWeekly Application In the Management of Diabetic Foot Ulcers

The purpose of this study is to determine whether a weekly application of EpiFix human
amniotic membrane is more effective than a biweekly application (every two weeks) in the
treatment of diabetic foot ulcers.

Inclusion Criteria:

1. Male or female age 18 or older

2. Informed consent must be obtained

3. Patient's ulcer must be diabetic in origin and larger than 1cm2. Debridement will be
done prior to randomization. Subject's informed consent for participating in this
study, must be obtained prior to proceeding with sharp debridement.

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 prior treatment to heal the wound. A two week run in
period will precede enrollment/randomization in the trial to document the indolent
nature of the wounds selected

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

7. Wound must be present anatomically on the plantar surface of the foot

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

9. Patient is of legal consenting age.

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

11. Serum Creatine less then 3.0mg/dl

12. HbA1c less than 12%

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

- Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR

- ABIs with results of ≥0.7 and ≤1.2, OR

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

Exclusion Criteria:

1. Patients presenting with an ulcer probing to 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 25cm2.

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.

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. Patient who are pregnant or breast feeding

15. Patient who are taking medications that are considered immune system modulator which
could affect graft incorporation.

16. Allergy to Gentamycin or Streptomycin

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

18. Wound improving greater than 20% over the first two weeks of the trial using standard
of care dressing and Cam Boot
We found this trial at
Roanoke, VA
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