A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers.

"A prospective, stratified, randomised, comparative, parallel group, non blinded clinical trial comparing the proportion of ulcers completely healed with the use of dehydrated human amniotic membrane allograft (EpiFix®, MiMedx, Kennesaw, GA) versus a standard protocol of wound care (moist wound therapy) in diabetic patients with a foot ulcer was conducted. The single‐centre trial was conducted in Southwest Virginia under the direction of a senior clinician with expertise in diabetic foot care with continuous enrolment of all eligible patients who wished to participate. Patients read and signed an IRB‐approved informed consent form prior to any study involvement. The study design conformed to the ethical guidelines of the 1975 Declaration of Helsinki and was reviewed and approved by Western IRB and preregistered in ClinicalTrials.gov (NCT01552499). The study population was comprised of patients with a history of type 1 or type 2 diabetes presenting for care of a diabetic ulcer located anywhere on the foot. Study inclusion criteria were as follows: age 18 or older; able and willing to provide consent and agree to comply with study procedures and follow‐up evaluations; ulcer size >1 and <25 cm2; ulcer duration of ≥4 weeks; no clinical signs of infection; serum creatinine < 3·0 mg/dl; glycosylated haemoglobin (HbA1c) < 12%; adequate circulation to the affected extremity as demonstrated by dorsum transcutaneous oxygen test (TcPO2) ≥ 30 mmHg, ankle‐brachial index (ABI) between 0·7 and 1·2 or triphasic or biphasic Doppler arterial waveforms at the ankle of affected leg. Patients were excluded if any of the following were present: 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 and allergy to gentamicin or streptomycin. Screening evaluations consisted of a medical history and physical examination, an infection assessment, wound site measurement, serum creatinine, HbA1c and a vascular assessment including circulation to the affected extremity (dorsum TcPO2, ABIs or Doppler arterial waveforms) within the last 60 days. Eligible patients meeting criteria were then randomised to receive either the EpiFix allograft material in addition to the standard regimen of wound care or a standard regimen of wound care alone in a 1:1 ratio. The randomisation schedule was balanced and permuted in blocks of 10."