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. 2014 Feb 21;11(2):122–128. doi: 10.1111/iwj.12242

Table 1.

Major inclusion and exclusion criteria

Inclusion criteria Exclusion criteria
  • Age 18 or older

  • Type 1 or Type 2 diabetes

  • Able and willing to provide consent and agrees to comply with study procedures and follow‐up evaluations

  • Foot ulcer size >1 cm2 and <25 cm2

  • Ulcer duration of ≥4 weeks, unresponsive to standard wound care

  • No clinical signs of infection

  • Serum creatinine <3·0 mg/dl

  • HgA1c <12%

  • Adequate circulation to the affected extremity as demonstrated by dorsum transcutaneous oxygen test (TcPO2) ≥ 30 mmHg, or ABI between 0·7 and 1·2, or triphasic or biphasic doppler arterial waveforms at the ankle of affected leg

  • Participating in another clinical trial

  • Charcot foot

  • Index ulcer probing to bone

  • Currently receiving radiation or chemotherapy

  • Known or suspected malignancy of current ulcer

  • Diagnosis of autoimmune connective tissue disease

  • Received a biomedical or topical growth factor for their wound within the previous 30 days

  • Pregnant or breast feeding

  • Taking medications considered to be immune system modulators

  • Allergy to gentamicin or streptomycin.