SLR - April 2018 - Rebecca V. DeSimone

A Prospective, Multicenter, Open-Label, Single-Arm Clinical Trial for Treatment of Chronic Complex Diabetic Foot Wounds with Exposed Tendon and/or Bone: Positive Clinical Outcomes of Viable Cryopreserved Human Placental Membrane

Reference: Frykberg R, Gibbons G, Walters J, Wukich D, Milstein F. A Prospective, Multicenter, Open-Label, Single-Arm Clinical Trial for Treatment of Chronic Complex Diabetic Foot Wounds with Exposed Tendon and/or Bone: Positive Clinical Outcomes of Viable Cryopreserved Human Placental Membrane. International Wound Journal. 2017. 14(3); 569–577.

Scientific Literature Review

Reviewed By: Rebecca V. DeSimone, DPM
Residency Program: Temple University Hospital, Philadelphia, PA

Podiatric Relevance: Diabetes has become a leading cause of morbidity in the American population considering the multisystem organ involvement. With the rising number of people living with diabetes in our population, podiatrists are seeing a growing number of patients with diabetic wounds of the foot and ankle in conjunction with comorbidities, such as peripheral vascular disease, that leads to delayed healing. These wounds can be present for weeks to years and involve soft tissue, sometimes extending to underlying layers of tendons and bone, which make them challenging to treat. Podiatrists have become the physicians at the front line of treating and preventing severe wounds that lead to morbidity and mortality of this population of patients. This study focuses on a new treatment option utilizing human placental membrane (HPM) for complicated diabetic wounds with exposed tendon or bone.

Methods: A level 1 prospective, open-label, single-arm clinical trial was conducted on 27 patients with diabetic wounds with exposure of underlying soft tissue and/or bone (including tendon, muscle, fascia, joint capsule and bone). This was accomplished via application of human placental membrane wound graft over these wounds weekly over a period of 16 weeks or until the wound achieved 100 percent granulation, which was the primary outcome of this study. All of the patients in this study were diabetic, had a wound with total surface area of <15cm2 and had ankle brachial index (ABI) ≥0.5 and ≤1.2 or toe systolic pressure ≥40 mmHg or TcPO2/skin perfusion pressure >30 mmHg. Each week, the wounds were debrided, cleansed, measured and had HPM applied along with an absorptive foam dressing. Patients ambulated in a fixed-ankle, offloading boot or postoperative surgical shoe for those with dorsal foot wounds.

Results: By the end of the 16-week trial, 93.3 percent of participants had 100 percent granulation of the original wound with coverage of previously exposed layers of tendon, fascia, muscle or bone. It took an average of six to eight weeks for 100 percent granulation. Complete wound closure occurred in 59.3 percent of all patients enrolled in the trial. At the eight-week mark, wounds had decreased in size by an average of 72.8 percent and by the last application at 16 weeks, wounds had deceased by an average of 92.3 percent.

Conclusions:
Use of human placental membrane wound dressing is a reasonable and effective treatment for management of deep diabetic foot wounds with exposed underlying structures. The patients in this study had comorbidities that are frequently exclusion criteria for clinical trials, including conditions like history of prior amputation, hypertension, renal disease and cardiac disease. These patients are more susceptible to infections and morbidity from open, deep foot wounds. The results of this prospective study give physicians a viable treatment option for wound management and early granulation in complex diabetic foot wounds.

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