A prospective, multicentre, 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

Abstract

Complex diabetic foot ulcers (DFUs) with exposed tendon or bone remain a challenge. They are more susceptible to complications such as infection and amputation and require treatments that promote rapid development of granulation tissue and, ultimately, reepithelialisation. The clinical effectiveness of viable cryopreserved human placental membrane (vCHPM) for DFUs has been established in a level 1 trial. However, complex wounds with exposed deeper structures are typically excluded from randomised controlled clinical trials despite being common in clinical practice. We report the results of a prospective, multicentre, open-label, single-arm clinical trial to establish clinical outcomes when vCHPM is applied weekly to complex DFUs with exposed deep structures. Patients with type 1 or type 2 diabetes and a complex DFU extending through the dermis with evidence of exposed muscle, tendon, fascia, bone and/or joint capsule were eligible for inclusion. Of the 31 patients enrolled, 27 completed the study. The mean wound area was 14·6 cm , and mean duration was 7·5 months. For patients completing the protocol, the primary endpoint, 100% wound granulation by week 16, was met by 96·3% of patients in a mean of 6·8 weeks. Complete wound closure occurred in 59·3% (mean 9·1 weeks). The 4-week percent area reduction was 54·3%. There were no product-related adverse events. Four patients (13%) withdrew, two (6·5%) for non-compliance and two (6·5%) for surgical intervention.

Effectiveness of viable cryopreserved placental membranes for management of diabetic foot ulcers in a real world setting

“…The results of this retrospective cohort study are similar to retrospective cohort studies and prospective RCTs in patients with DFUs . Almost 60% of DFUs achieved closure with a median time to closure of 42.0 days with a median of 4 applications of vCPM.…”

Novel Approach for Enterocutaneous Fistula Treatment with the Use of Viable Cryopreserved Placental Membrane

“…The chorionic membrane is jelly-like that allows easy application into a narrow fistula's tract. Our hypothesis is that the soft chorionic graft fills fistula and supports formation of granulation tissue followed by the closure of the fistula similar as it was reported for complex leg wounds [31]. …”

“…Retrospective and prospective clinical studies have demonstrated benefits of Grafix Prime for wounds of various etiology including venous stasis ulcers, diabetic foot ulcers, pressure ulcers, and surgical dehiscence [29, 30]. The clinical effectiveness of viable cryopreserved chorionic membrane for complex wounds with exposed tendon and/or bone has been demonstrated in a recent prospective multicenter clinical trial [31]. In this study 96.3% patients achieved 100% granulation of the wound bed, and 59.3% of patients completely closed their wounds [31].…”

“…The clinical effectiveness of viable cryopreserved chorionic membrane for complex wounds with exposed tendon and/or bone has been demonstrated in a recent prospective multicenter clinical trial [31]. In this study 96.3% patients achieved 100% granulation of the wound bed, and 59.3% of patients completely closed their wounds [31]. Because ECF is a surgical wound and placental membranes are beneficial for wounds including surgical ones [32], we hypothesized that placental membranes might be beneficial for ECF management.…”

Nonsurgical management of a large necrotic nasal tip wound using a viable cryopreserved placental membrane

“…Scientific studies show that vCPM retain all components and properties of native fresh tissue 9. Retrospective and prospective clinical studies report positive outcomes with vCPM in management of acute and chronic wounds including complex wounds with exposed bone, tendon, or joint capsule 10, 11, 12, 13. Previously we reported vCPM use for outpatient management of two complex burn wounds that prevented potential amputation in one patient and formation of finger contracture in the second patient.…”